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The five biggest changes in the 2023 adult vaccine schedules
This transcript has been edited for clarity.
Hello. I’m Dr Sandra Fryhofer. Welcome to Medicine Matters.
It’s a new year, which means a new ACIP adult immunization schedule – a valuable resource collating ACIP’s most up-to-date vaccination recommendations.
Here are this year’s five most important changes:
- COVID vaccines now front and center
- New emphasis on polio vaccination
- Inclusion of some nonvaccine products (such as monoclonal antibody products)
- Pharmacists group has approved the schedule for the first time
- New shared clinical decision-making option for pneumococcal vaccines
The schedule’s organization remains the same. It still has four sections:
- Table 1: vaccinations by age
- Table 2: vaccinations by medical condition and other indications
- The Notes section (alphabetically ordered by vaccine type)
- Appendix listing of vaccine-specific contraindications and precautions
But what’s unique this year is that some of the abbreviations have historical implications. The first change is no big surprise in light of what we’ve gone through in the past few years. COVID vaccines are listed first on the cover page by brand name for those authorized and by company name for those still under US emergency use authorization. They’re also listed first on the graphics and in the notes.
COVID and mRNA and protein-based vaccines have now been assigned official abbreviations based on vaccine platform and valency.
- 1vCOV-mRNA: Comirnaty/Pfizer-BioNTech and Spikevax Moderna COVID-19 vaccines
- 2vCOV-mRNA: Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines
- 1vCOV-aPS: Novavax COVID-19 vaccine
Also remarkable is the absence of COVID viral vector vaccines on the list. However, the viral vector COVID vaccine (which has been available but is not preferred) does have a CDC website link in the Notes section.
A sad but necessary inclusion was triggered by recent polio cases in New York. Polio was believed to be eradicated, and we thought adults no longer needed to be vaccinated against polio. In the new schedule, the polio vaccine is listed on the cover page but is not included in the tables. Current polio vaccination recommendations are now in the Notes section.
Also of historical significance and something that may set a precedent is the inclusion of nonvaccine products. The value of COVID preexposure prophylaxis with products including monoclonal antibodies (such as Evusheld) for people who are moderately or severely immunocompromised is mentioned in the Notes section.
For the first time ever, the schedule has been approved by the American Pharmacists Association, which validates pharmacists as established partners in vaccine administration.
Color-code key
One aspect of the schedule that has not changed is the color-code key:
- Yellow: Recommended if the patient meets the age requirement
- Purple: Indicated for those with additional risk factors or another indication
- Blue: Recommended based on shared clinical decision-making
- Orange: Precaution
- Red: Contraindicated or not recommended; the vaccine should not be administered. Overlays on the red more precisely clarify whether a vaccine is really contraindicated or just not recommended. An asterisk on red means vaccinate after pregnancy if indicated.
- Gray: No recommendation or not applicable
Vaccinations by age
Table 1 lists recommended vaccinations by age. There is one major change. COVID vaccines are on the first row of the graphic, with the need for both a primary series and boosters emphasized on the overlay. The notes have hyperlinks to the most up-to-date COVID vaccination recommendations.
Pneumococcal vaccination. Pneumococcal vaccination is routinely recommended starting at age 65. Current recommendations for those not previously vaccinated have not changed since last year. But on Table 1, the bottom half of the row for those 65 or older is now blue (and that’s new). This new color blue means shared clinical decision-making and applies to people who were previously considered fully vaccinated with the now extinct combination of PCV13 and PPSV23. These patients now have the option of getting a dose of PCV20 five years after completing their PCV13-PPSV23 combo series. This option is blue because the decision is up to you and your patient.
Check the notes for more pneumococcal vaccination details. For example, for those partially vaccinated using lower valency vaccines, there’s an option of substituting PCV20 for PPSV23 to broaden and increase durability of protection.
The pneumococcal vaccination recommendation options are complicated. A new pneumococcal vaccination app can help.
Hepatitis B. For adults under age 60, the color code for the hepatitis B vaccine is yellow, meaning it’s indicated for all. For older patients, the color code is purple. If a patient who is age 60 or older wants the hepatitis B vaccine, they can have it even in the absence of additional risk indications.
Vaccinations by medical condition or other indications
Other than a few minor word changes on the overlay, the only thing that’s new is the COVID vaccine row.
This table is helpful for matching vaccine recommendations with specific medical conditions, including pregnancy, immunocompromise, HIV (with specifics according to CD4 count), asplenia, complement deficiencies, heart disease, lung disease, alcoholism, chronic liver disease, diabetes, health care personnel, and men who have sex with men.
Use this table to dot the i’s and cross the t’s when it comes to vaccination recommendations. For example, take a look at the pregnancy column. Live virus vaccines, including LAIV, MMR, and varicella, are contraindicated and color-coded red. MMR and varicella also have an asterisk, meaning vaccinate after pregnancy if indicated. HPV vaccines are not live virus vaccines, but the overlay says they are not recommended during pregnancy. The asterisk indicates that you can vaccinate after pregnancy.
Vaccine notes
The notes are in alphabetical order, and their organization (routine, special situations, and shared clinical decision-making when indicated) has not changed. They are concise and succinct, but sometimes they’re not enough. That’s why vaccine-specific links to more complete recommendations are so convenient.
Notes for hepatitis B contain nuances on specific dosing for vaccinating patients on dialysis, as well as a reminder that newer hepatitis C vaccines such as Heplisav and PreHevbrio are not recommended during pregnancy due to lack of safety data.
For influenza, everyone 6 months or older still needs yearly flu vaccination with an age- and health-appropriate flu vaccine. But for those aged 65 or older, the notes specify the three vaccine versions now preferred: high-dose, recombinant, or adjuvanted versions. However, if these aren’t available, it’s better to get any flu vaccine than to go without.
Under meningococcal vaccines, the notes for MenACWY and MenB are combined. For MenB, trade names Bexsero and Trumenba are specified because the products are not interchangeable. Booster intervals for those still at risk are different for each vaccine type: every 5 years for MenACWY boosters, and every 2-3 years for boosts of MenB.
The recent polio cases in New York have put polio vaccination in the spotlight. ACIP has now reinstated its Polio Vaccine Work Group. The new schedule lists polio vaccines on the cover page. Current recommendations have been added to the notes section. Routine vaccination for adults is not necessary, at least for now. However, those at increased risk for exposure to polio fall in the special-situation category. For those at increased risk who have completed a polio vaccine series, a single lifetime IPV booster can be given. For those at increased risk who have not completed their polio vaccine series, now would be the time to finish the series.
Appendix
The final step in using the new schedule is checking the appendix and its list of vaccine-specific contraindications and precautions.
I hope this review of the new ACIP adult immunization schedule has been helpful. For Medicine Matters, I’m Dr. Sandra Fryhofer.
Dr. Fryhofer is clinical associate professor of medicine, Emory University, Atlanta. She reported numerous conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. I’m Dr Sandra Fryhofer. Welcome to Medicine Matters.
It’s a new year, which means a new ACIP adult immunization schedule – a valuable resource collating ACIP’s most up-to-date vaccination recommendations.
Here are this year’s five most important changes:
- COVID vaccines now front and center
- New emphasis on polio vaccination
- Inclusion of some nonvaccine products (such as monoclonal antibody products)
- Pharmacists group has approved the schedule for the first time
- New shared clinical decision-making option for pneumococcal vaccines
The schedule’s organization remains the same. It still has four sections:
- Table 1: vaccinations by age
- Table 2: vaccinations by medical condition and other indications
- The Notes section (alphabetically ordered by vaccine type)
- Appendix listing of vaccine-specific contraindications and precautions
But what’s unique this year is that some of the abbreviations have historical implications. The first change is no big surprise in light of what we’ve gone through in the past few years. COVID vaccines are listed first on the cover page by brand name for those authorized and by company name for those still under US emergency use authorization. They’re also listed first on the graphics and in the notes.
COVID and mRNA and protein-based vaccines have now been assigned official abbreviations based on vaccine platform and valency.
- 1vCOV-mRNA: Comirnaty/Pfizer-BioNTech and Spikevax Moderna COVID-19 vaccines
- 2vCOV-mRNA: Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines
- 1vCOV-aPS: Novavax COVID-19 vaccine
Also remarkable is the absence of COVID viral vector vaccines on the list. However, the viral vector COVID vaccine (which has been available but is not preferred) does have a CDC website link in the Notes section.
A sad but necessary inclusion was triggered by recent polio cases in New York. Polio was believed to be eradicated, and we thought adults no longer needed to be vaccinated against polio. In the new schedule, the polio vaccine is listed on the cover page but is not included in the tables. Current polio vaccination recommendations are now in the Notes section.
Also of historical significance and something that may set a precedent is the inclusion of nonvaccine products. The value of COVID preexposure prophylaxis with products including monoclonal antibodies (such as Evusheld) for people who are moderately or severely immunocompromised is mentioned in the Notes section.
For the first time ever, the schedule has been approved by the American Pharmacists Association, which validates pharmacists as established partners in vaccine administration.
Color-code key
One aspect of the schedule that has not changed is the color-code key:
- Yellow: Recommended if the patient meets the age requirement
- Purple: Indicated for those with additional risk factors or another indication
- Blue: Recommended based on shared clinical decision-making
- Orange: Precaution
- Red: Contraindicated or not recommended; the vaccine should not be administered. Overlays on the red more precisely clarify whether a vaccine is really contraindicated or just not recommended. An asterisk on red means vaccinate after pregnancy if indicated.
- Gray: No recommendation or not applicable
Vaccinations by age
Table 1 lists recommended vaccinations by age. There is one major change. COVID vaccines are on the first row of the graphic, with the need for both a primary series and boosters emphasized on the overlay. The notes have hyperlinks to the most up-to-date COVID vaccination recommendations.
Pneumococcal vaccination. Pneumococcal vaccination is routinely recommended starting at age 65. Current recommendations for those not previously vaccinated have not changed since last year. But on Table 1, the bottom half of the row for those 65 or older is now blue (and that’s new). This new color blue means shared clinical decision-making and applies to people who were previously considered fully vaccinated with the now extinct combination of PCV13 and PPSV23. These patients now have the option of getting a dose of PCV20 five years after completing their PCV13-PPSV23 combo series. This option is blue because the decision is up to you and your patient.
Check the notes for more pneumococcal vaccination details. For example, for those partially vaccinated using lower valency vaccines, there’s an option of substituting PCV20 for PPSV23 to broaden and increase durability of protection.
The pneumococcal vaccination recommendation options are complicated. A new pneumococcal vaccination app can help.
Hepatitis B. For adults under age 60, the color code for the hepatitis B vaccine is yellow, meaning it’s indicated for all. For older patients, the color code is purple. If a patient who is age 60 or older wants the hepatitis B vaccine, they can have it even in the absence of additional risk indications.
Vaccinations by medical condition or other indications
Other than a few minor word changes on the overlay, the only thing that’s new is the COVID vaccine row.
This table is helpful for matching vaccine recommendations with specific medical conditions, including pregnancy, immunocompromise, HIV (with specifics according to CD4 count), asplenia, complement deficiencies, heart disease, lung disease, alcoholism, chronic liver disease, diabetes, health care personnel, and men who have sex with men.
Use this table to dot the i’s and cross the t’s when it comes to vaccination recommendations. For example, take a look at the pregnancy column. Live virus vaccines, including LAIV, MMR, and varicella, are contraindicated and color-coded red. MMR and varicella also have an asterisk, meaning vaccinate after pregnancy if indicated. HPV vaccines are not live virus vaccines, but the overlay says they are not recommended during pregnancy. The asterisk indicates that you can vaccinate after pregnancy.
Vaccine notes
The notes are in alphabetical order, and their organization (routine, special situations, and shared clinical decision-making when indicated) has not changed. They are concise and succinct, but sometimes they’re not enough. That’s why vaccine-specific links to more complete recommendations are so convenient.
Notes for hepatitis B contain nuances on specific dosing for vaccinating patients on dialysis, as well as a reminder that newer hepatitis C vaccines such as Heplisav and PreHevbrio are not recommended during pregnancy due to lack of safety data.
For influenza, everyone 6 months or older still needs yearly flu vaccination with an age- and health-appropriate flu vaccine. But for those aged 65 or older, the notes specify the three vaccine versions now preferred: high-dose, recombinant, or adjuvanted versions. However, if these aren’t available, it’s better to get any flu vaccine than to go without.
Under meningococcal vaccines, the notes for MenACWY and MenB are combined. For MenB, trade names Bexsero and Trumenba are specified because the products are not interchangeable. Booster intervals for those still at risk are different for each vaccine type: every 5 years for MenACWY boosters, and every 2-3 years for boosts of MenB.
The recent polio cases in New York have put polio vaccination in the spotlight. ACIP has now reinstated its Polio Vaccine Work Group. The new schedule lists polio vaccines on the cover page. Current recommendations have been added to the notes section. Routine vaccination for adults is not necessary, at least for now. However, those at increased risk for exposure to polio fall in the special-situation category. For those at increased risk who have completed a polio vaccine series, a single lifetime IPV booster can be given. For those at increased risk who have not completed their polio vaccine series, now would be the time to finish the series.
Appendix
The final step in using the new schedule is checking the appendix and its list of vaccine-specific contraindications and precautions.
I hope this review of the new ACIP adult immunization schedule has been helpful. For Medicine Matters, I’m Dr. Sandra Fryhofer.
Dr. Fryhofer is clinical associate professor of medicine, Emory University, Atlanta. She reported numerous conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hello. I’m Dr Sandra Fryhofer. Welcome to Medicine Matters.
It’s a new year, which means a new ACIP adult immunization schedule – a valuable resource collating ACIP’s most up-to-date vaccination recommendations.
Here are this year’s five most important changes:
- COVID vaccines now front and center
- New emphasis on polio vaccination
- Inclusion of some nonvaccine products (such as monoclonal antibody products)
- Pharmacists group has approved the schedule for the first time
- New shared clinical decision-making option for pneumococcal vaccines
The schedule’s organization remains the same. It still has four sections:
- Table 1: vaccinations by age
- Table 2: vaccinations by medical condition and other indications
- The Notes section (alphabetically ordered by vaccine type)
- Appendix listing of vaccine-specific contraindications and precautions
But what’s unique this year is that some of the abbreviations have historical implications. The first change is no big surprise in light of what we’ve gone through in the past few years. COVID vaccines are listed first on the cover page by brand name for those authorized and by company name for those still under US emergency use authorization. They’re also listed first on the graphics and in the notes.
COVID and mRNA and protein-based vaccines have now been assigned official abbreviations based on vaccine platform and valency.
- 1vCOV-mRNA: Comirnaty/Pfizer-BioNTech and Spikevax Moderna COVID-19 vaccines
- 2vCOV-mRNA: Pfizer-BioNTech and Moderna bivalent COVID-19 vaccines
- 1vCOV-aPS: Novavax COVID-19 vaccine
Also remarkable is the absence of COVID viral vector vaccines on the list. However, the viral vector COVID vaccine (which has been available but is not preferred) does have a CDC website link in the Notes section.
A sad but necessary inclusion was triggered by recent polio cases in New York. Polio was believed to be eradicated, and we thought adults no longer needed to be vaccinated against polio. In the new schedule, the polio vaccine is listed on the cover page but is not included in the tables. Current polio vaccination recommendations are now in the Notes section.
Also of historical significance and something that may set a precedent is the inclusion of nonvaccine products. The value of COVID preexposure prophylaxis with products including monoclonal antibodies (such as Evusheld) for people who are moderately or severely immunocompromised is mentioned in the Notes section.
For the first time ever, the schedule has been approved by the American Pharmacists Association, which validates pharmacists as established partners in vaccine administration.
Color-code key
One aspect of the schedule that has not changed is the color-code key:
- Yellow: Recommended if the patient meets the age requirement
- Purple: Indicated for those with additional risk factors or another indication
- Blue: Recommended based on shared clinical decision-making
- Orange: Precaution
- Red: Contraindicated or not recommended; the vaccine should not be administered. Overlays on the red more precisely clarify whether a vaccine is really contraindicated or just not recommended. An asterisk on red means vaccinate after pregnancy if indicated.
- Gray: No recommendation or not applicable
Vaccinations by age
Table 1 lists recommended vaccinations by age. There is one major change. COVID vaccines are on the first row of the graphic, with the need for both a primary series and boosters emphasized on the overlay. The notes have hyperlinks to the most up-to-date COVID vaccination recommendations.
Pneumococcal vaccination. Pneumococcal vaccination is routinely recommended starting at age 65. Current recommendations for those not previously vaccinated have not changed since last year. But on Table 1, the bottom half of the row for those 65 or older is now blue (and that’s new). This new color blue means shared clinical decision-making and applies to people who were previously considered fully vaccinated with the now extinct combination of PCV13 and PPSV23. These patients now have the option of getting a dose of PCV20 five years after completing their PCV13-PPSV23 combo series. This option is blue because the decision is up to you and your patient.
Check the notes for more pneumococcal vaccination details. For example, for those partially vaccinated using lower valency vaccines, there’s an option of substituting PCV20 for PPSV23 to broaden and increase durability of protection.
The pneumococcal vaccination recommendation options are complicated. A new pneumococcal vaccination app can help.
Hepatitis B. For adults under age 60, the color code for the hepatitis B vaccine is yellow, meaning it’s indicated for all. For older patients, the color code is purple. If a patient who is age 60 or older wants the hepatitis B vaccine, they can have it even in the absence of additional risk indications.
Vaccinations by medical condition or other indications
Other than a few minor word changes on the overlay, the only thing that’s new is the COVID vaccine row.
This table is helpful for matching vaccine recommendations with specific medical conditions, including pregnancy, immunocompromise, HIV (with specifics according to CD4 count), asplenia, complement deficiencies, heart disease, lung disease, alcoholism, chronic liver disease, diabetes, health care personnel, and men who have sex with men.
Use this table to dot the i’s and cross the t’s when it comes to vaccination recommendations. For example, take a look at the pregnancy column. Live virus vaccines, including LAIV, MMR, and varicella, are contraindicated and color-coded red. MMR and varicella also have an asterisk, meaning vaccinate after pregnancy if indicated. HPV vaccines are not live virus vaccines, but the overlay says they are not recommended during pregnancy. The asterisk indicates that you can vaccinate after pregnancy.
Vaccine notes
The notes are in alphabetical order, and their organization (routine, special situations, and shared clinical decision-making when indicated) has not changed. They are concise and succinct, but sometimes they’re not enough. That’s why vaccine-specific links to more complete recommendations are so convenient.
Notes for hepatitis B contain nuances on specific dosing for vaccinating patients on dialysis, as well as a reminder that newer hepatitis C vaccines such as Heplisav and PreHevbrio are not recommended during pregnancy due to lack of safety data.
For influenza, everyone 6 months or older still needs yearly flu vaccination with an age- and health-appropriate flu vaccine. But for those aged 65 or older, the notes specify the three vaccine versions now preferred: high-dose, recombinant, or adjuvanted versions. However, if these aren’t available, it’s better to get any flu vaccine than to go without.
Under meningococcal vaccines, the notes for MenACWY and MenB are combined. For MenB, trade names Bexsero and Trumenba are specified because the products are not interchangeable. Booster intervals for those still at risk are different for each vaccine type: every 5 years for MenACWY boosters, and every 2-3 years for boosts of MenB.
The recent polio cases in New York have put polio vaccination in the spotlight. ACIP has now reinstated its Polio Vaccine Work Group. The new schedule lists polio vaccines on the cover page. Current recommendations have been added to the notes section. Routine vaccination for adults is not necessary, at least for now. However, those at increased risk for exposure to polio fall in the special-situation category. For those at increased risk who have completed a polio vaccine series, a single lifetime IPV booster can be given. For those at increased risk who have not completed their polio vaccine series, now would be the time to finish the series.
Appendix
The final step in using the new schedule is checking the appendix and its list of vaccine-specific contraindications and precautions.
I hope this review of the new ACIP adult immunization schedule has been helpful. For Medicine Matters, I’m Dr. Sandra Fryhofer.
Dr. Fryhofer is clinical associate professor of medicine, Emory University, Atlanta. She reported numerous conflicts of interest.
A version of this article first appeared on Medscape.com.
AAP approves 2023 child and adolescent immunization schedule
The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2023.
In a policy statement published online in the journal Pediatrics, the AAP said the updated recommendations do not include major changes from those released in 2022 by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
In one small shift, COVID-19 is now addressed in the main text instead of being relegated to the notes section.
“And a new vaccine – Priorix [GlaxoSmithKline] – has been added for MMR [measles, mumps, rubella], so now there are two available,” Sean T. O’Leary, MD, MPH, chair of the AAP’s Committee on Infectious Diseases, told this news organization. “There’s also a second pneumococcal conjugate vaccine listed, PCV15, and this and PCV13 can essentially be used interchangeably.”
Minor updates to the schedule, reflected on the cover page, relate to vaccines for COVID-19, dengue fever, and pneumococcal disease, added Dr. O’Leary, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado, Aurora.
The committee also changed layouts to improve the usability of the schedule. Updated annually, the guidance provides a table on recommended pediatric immunizations from birth to age 18 years, and catch-up recommendations for children aged 4 months to 18 years who start their vaccinations late or are more than 1 month behind the recommended age for vaccine administration.
“We hope this annual update will encourage clinicians to make sure all their patients are up to date on their routine vaccinations,” Dr. O’Leary said. “It’s an opportunity to develop strategies to improve vaccination rates.”
The 2023 schedule follows news from the CDC that kindergarten vaccination rates declined during the 2021-2022 school year. Only 93% of kindergarteners obtained full vaccinations, representing a drop of 1 percentage point from the year before and 2 percentage points from the 2019-2020 school year.
The dip in coverage has been attributed to disruptions caused by the COVID-19 pandemic. AAP advises health care professionals to urge families to make sure their child’s vaccines are current.
Among other additions:
In Table 1
- MMR: Second vaccine added (Priorix, GlaxoSmithKline Biologicals)
- Pneumococcal disease: second conjugate vaccine, PCV15, added (Vaxneuvance, Merck Sharp & Dohme).
- COVID-19: New row added.
- Dengue: Text changed from “Seropositive in endemic areas only” to “Seropositive in endemic dengue areas.”
- Inactivated polio vaccine: “See Notes” added to the column for children aged 18 years.
In Table 2
- PCV: Dose 3 to dose 4 interval revised to align with ACIP’s recommendation for dose 4. This dose is necessary only for children ages 12-59 months regardless of risk, or age 60-71 months with any risk who received three doses before age 12 months.
A parent-friendly vaccine schedule for children and adolescents is available on the CDC’s website.
“Vaccines are essential for the health of our whole society, including children and adolescents,” Dr. O’Leary said in a press release from AAP. “These schedules provide a road map [that] parents and pediatricians can follow to help children get the vaccines they need so their immune systems will be ready to recognize and resist diseases.”
As previously, the 2023 schedule was adjusted to ensure consistency between the formats of the childhood/adolescent and adult immunization guidance. A meeting of stakeholder organizations in October 2022 harmonized the two formats.
A version of this article first appeared on Medscape.com.
The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2023.
In a policy statement published online in the journal Pediatrics, the AAP said the updated recommendations do not include major changes from those released in 2022 by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
In one small shift, COVID-19 is now addressed in the main text instead of being relegated to the notes section.
“And a new vaccine – Priorix [GlaxoSmithKline] – has been added for MMR [measles, mumps, rubella], so now there are two available,” Sean T. O’Leary, MD, MPH, chair of the AAP’s Committee on Infectious Diseases, told this news organization. “There’s also a second pneumococcal conjugate vaccine listed, PCV15, and this and PCV13 can essentially be used interchangeably.”
Minor updates to the schedule, reflected on the cover page, relate to vaccines for COVID-19, dengue fever, and pneumococcal disease, added Dr. O’Leary, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado, Aurora.
The committee also changed layouts to improve the usability of the schedule. Updated annually, the guidance provides a table on recommended pediatric immunizations from birth to age 18 years, and catch-up recommendations for children aged 4 months to 18 years who start their vaccinations late or are more than 1 month behind the recommended age for vaccine administration.
“We hope this annual update will encourage clinicians to make sure all their patients are up to date on their routine vaccinations,” Dr. O’Leary said. “It’s an opportunity to develop strategies to improve vaccination rates.”
The 2023 schedule follows news from the CDC that kindergarten vaccination rates declined during the 2021-2022 school year. Only 93% of kindergarteners obtained full vaccinations, representing a drop of 1 percentage point from the year before and 2 percentage points from the 2019-2020 school year.
The dip in coverage has been attributed to disruptions caused by the COVID-19 pandemic. AAP advises health care professionals to urge families to make sure their child’s vaccines are current.
Among other additions:
In Table 1
- MMR: Second vaccine added (Priorix, GlaxoSmithKline Biologicals)
- Pneumococcal disease: second conjugate vaccine, PCV15, added (Vaxneuvance, Merck Sharp & Dohme).
- COVID-19: New row added.
- Dengue: Text changed from “Seropositive in endemic areas only” to “Seropositive in endemic dengue areas.”
- Inactivated polio vaccine: “See Notes” added to the column for children aged 18 years.
In Table 2
- PCV: Dose 3 to dose 4 interval revised to align with ACIP’s recommendation for dose 4. This dose is necessary only for children ages 12-59 months regardless of risk, or age 60-71 months with any risk who received three doses before age 12 months.
A parent-friendly vaccine schedule for children and adolescents is available on the CDC’s website.
“Vaccines are essential for the health of our whole society, including children and adolescents,” Dr. O’Leary said in a press release from AAP. “These schedules provide a road map [that] parents and pediatricians can follow to help children get the vaccines they need so their immune systems will be ready to recognize and resist diseases.”
As previously, the 2023 schedule was adjusted to ensure consistency between the formats of the childhood/adolescent and adult immunization guidance. A meeting of stakeholder organizations in October 2022 harmonized the two formats.
A version of this article first appeared on Medscape.com.
The American Academy of Pediatrics said it supports the Recommended Childhood and Adolescent Immunization Schedule: United States, 2023.
In a policy statement published online in the journal Pediatrics, the AAP said the updated recommendations do not include major changes from those released in 2022 by the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.
In one small shift, COVID-19 is now addressed in the main text instead of being relegated to the notes section.
“And a new vaccine – Priorix [GlaxoSmithKline] – has been added for MMR [measles, mumps, rubella], so now there are two available,” Sean T. O’Leary, MD, MPH, chair of the AAP’s Committee on Infectious Diseases, told this news organization. “There’s also a second pneumococcal conjugate vaccine listed, PCV15, and this and PCV13 can essentially be used interchangeably.”
Minor updates to the schedule, reflected on the cover page, relate to vaccines for COVID-19, dengue fever, and pneumococcal disease, added Dr. O’Leary, a professor of pediatrics at the University of Colorado Anschutz Medical Campus and Children’s Hospital Colorado, Aurora.
The committee also changed layouts to improve the usability of the schedule. Updated annually, the guidance provides a table on recommended pediatric immunizations from birth to age 18 years, and catch-up recommendations for children aged 4 months to 18 years who start their vaccinations late or are more than 1 month behind the recommended age for vaccine administration.
“We hope this annual update will encourage clinicians to make sure all their patients are up to date on their routine vaccinations,” Dr. O’Leary said. “It’s an opportunity to develop strategies to improve vaccination rates.”
The 2023 schedule follows news from the CDC that kindergarten vaccination rates declined during the 2021-2022 school year. Only 93% of kindergarteners obtained full vaccinations, representing a drop of 1 percentage point from the year before and 2 percentage points from the 2019-2020 school year.
The dip in coverage has been attributed to disruptions caused by the COVID-19 pandemic. AAP advises health care professionals to urge families to make sure their child’s vaccines are current.
Among other additions:
In Table 1
- MMR: Second vaccine added (Priorix, GlaxoSmithKline Biologicals)
- Pneumococcal disease: second conjugate vaccine, PCV15, added (Vaxneuvance, Merck Sharp & Dohme).
- COVID-19: New row added.
- Dengue: Text changed from “Seropositive in endemic areas only” to “Seropositive in endemic dengue areas.”
- Inactivated polio vaccine: “See Notes” added to the column for children aged 18 years.
In Table 2
- PCV: Dose 3 to dose 4 interval revised to align with ACIP’s recommendation for dose 4. This dose is necessary only for children ages 12-59 months regardless of risk, or age 60-71 months with any risk who received three doses before age 12 months.
A parent-friendly vaccine schedule for children and adolescents is available on the CDC’s website.
“Vaccines are essential for the health of our whole society, including children and adolescents,” Dr. O’Leary said in a press release from AAP. “These schedules provide a road map [that] parents and pediatricians can follow to help children get the vaccines they need so their immune systems will be ready to recognize and resist diseases.”
As previously, the 2023 schedule was adjusted to ensure consistency between the formats of the childhood/adolescent and adult immunization guidance. A meeting of stakeholder organizations in October 2022 harmonized the two formats.
A version of this article first appeared on Medscape.com.
FROM PEDIATRICS
Young children quickly outgrow the need for ear tubes
About half a million children between the ages of 1 and 3 years old have ear tube surgery in the United States every year at an annual cost exceeding $2 billion. It is the most common childhood surgery performed with anesthesia. It is a surgery commonly performed on children in most other high- and middle-income countries.
My group recently published a paper on the timing and necessity of tympanostomy tubes for recurrent otitis media in young children. The primary objective was to quantitatively examine recurrent acute otitis media (AOM) incidence with respect to age of occurrence, the influence of daycare attendance, and other risk factors in individual children. We introduced the concept of a “window of susceptibility” to AOM as new terminology referring to a child who has two or more closely spaced AOM occurrences during a window of time. We sought to know what to expect and how to advise the parent when a child presents with closely spaced AOMs.
A secondary objective was to develop models to predict the risk and timing of AOM recurrences based on the natural history of disease in young children who do not get tympanostomy tubes. Prediction models were developed to assist clinicians in understanding and explaining to parents the benefit of tympanostomy tubes based on the child’s age and number of AOMs.
The children were all from a primary care pediatric practice in Rochester, N.Y., which comprised a typical mixed demographic of largely middle-class, health care–insured families that was broadly representative of the racial/ethnic diversity in the community. The sample included both wealthy families and those living below the poverty line. The diagnosis of AOM was made based on the American Academy of Pediatrics guidance in which a presumed middle ear effusion and a full or bulging tympanic membrane were required. Almost all episodes (> 85%) of clinically diagnosed AOM cases were confirmed by culture of middle ear fluid collected by tympanocentesis to ensure diagnostic accuracy.
286 children who had ear infections were studied. We found that 80% of ear infections occurred during a very narrow window of susceptibility – age 6-21 months. About 72% of children had a window of susceptibility to ear infections that lasted 5 months or less; 97% of children had a window of susceptibility that lasted 10 months or less.
From this result, we observed that about 90% of children have a window of time lasting about 10 months when they get repeated ear infections. By the time a child gets three ear infections in 6 months (a period of time recommended by the AAP and American Academy of Otolaryngology–Head and Neck Surgery when ear tubes might be considered) and then a referral for ear tubes is made and the child gets an appointment with the ear, nose, and throat doctor, and surgery is scheduled, the ear infections were going to stop anyway.
In other words, millions of children worldwide have been getting ear tubes and physicians and parents saw that the ear infections stopped. So they concluded the ear tubes stopped the infections. We found the infections were going to stop anyway even if the child did not receive ear tubes because their susceptibility to ear infections is over by the time the surgery is performed. The child outgrew ear infections.
An exception was children in daycare at an early age. Our study found that children in daycare who are around 6 months old and start getting ear infections at that age are likely destined to have three or more ear infections in the first year of life. If children are going to be in daycare, perhaps those who need them should receive ear tubes early. Analysis of other demographic and risk factor covariates – sex, race/ethnicity, breastfeeding, siblings in the home, smoking in the home, atopy, and family history of otitis media – were not significantly associated with the number of AOMs in the child population we studied.
We developed a prediction model for doctors, so they could input a child’s age, number of ear infections, and daycare attendance and receive back an estimate of the number of likely future ear infections for that child. With that knowledge, physicians and parents can make more informed decisions.
Our message to clinicians and parents is to reconsider the necessity and timing of ear tube surgery for children with recurrent ear infections because the future is not predicted by the past. Children having several ear infections in a short time does not predict that they will have a similar number of ear infections in the future.
The study was supported by the National Institutes of Health awarded to Rochester Regional Health. Dr. Pichichero was principal investigator for the award.
Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.
About half a million children between the ages of 1 and 3 years old have ear tube surgery in the United States every year at an annual cost exceeding $2 billion. It is the most common childhood surgery performed with anesthesia. It is a surgery commonly performed on children in most other high- and middle-income countries.
My group recently published a paper on the timing and necessity of tympanostomy tubes for recurrent otitis media in young children. The primary objective was to quantitatively examine recurrent acute otitis media (AOM) incidence with respect to age of occurrence, the influence of daycare attendance, and other risk factors in individual children. We introduced the concept of a “window of susceptibility” to AOM as new terminology referring to a child who has two or more closely spaced AOM occurrences during a window of time. We sought to know what to expect and how to advise the parent when a child presents with closely spaced AOMs.
A secondary objective was to develop models to predict the risk and timing of AOM recurrences based on the natural history of disease in young children who do not get tympanostomy tubes. Prediction models were developed to assist clinicians in understanding and explaining to parents the benefit of tympanostomy tubes based on the child’s age and number of AOMs.
The children were all from a primary care pediatric practice in Rochester, N.Y., which comprised a typical mixed demographic of largely middle-class, health care–insured families that was broadly representative of the racial/ethnic diversity in the community. The sample included both wealthy families and those living below the poverty line. The diagnosis of AOM was made based on the American Academy of Pediatrics guidance in which a presumed middle ear effusion and a full or bulging tympanic membrane were required. Almost all episodes (> 85%) of clinically diagnosed AOM cases were confirmed by culture of middle ear fluid collected by tympanocentesis to ensure diagnostic accuracy.
286 children who had ear infections were studied. We found that 80% of ear infections occurred during a very narrow window of susceptibility – age 6-21 months. About 72% of children had a window of susceptibility to ear infections that lasted 5 months or less; 97% of children had a window of susceptibility that lasted 10 months or less.
From this result, we observed that about 90% of children have a window of time lasting about 10 months when they get repeated ear infections. By the time a child gets three ear infections in 6 months (a period of time recommended by the AAP and American Academy of Otolaryngology–Head and Neck Surgery when ear tubes might be considered) and then a referral for ear tubes is made and the child gets an appointment with the ear, nose, and throat doctor, and surgery is scheduled, the ear infections were going to stop anyway.
In other words, millions of children worldwide have been getting ear tubes and physicians and parents saw that the ear infections stopped. So they concluded the ear tubes stopped the infections. We found the infections were going to stop anyway even if the child did not receive ear tubes because their susceptibility to ear infections is over by the time the surgery is performed. The child outgrew ear infections.
An exception was children in daycare at an early age. Our study found that children in daycare who are around 6 months old and start getting ear infections at that age are likely destined to have three or more ear infections in the first year of life. If children are going to be in daycare, perhaps those who need them should receive ear tubes early. Analysis of other demographic and risk factor covariates – sex, race/ethnicity, breastfeeding, siblings in the home, smoking in the home, atopy, and family history of otitis media – were not significantly associated with the number of AOMs in the child population we studied.
We developed a prediction model for doctors, so they could input a child’s age, number of ear infections, and daycare attendance and receive back an estimate of the number of likely future ear infections for that child. With that knowledge, physicians and parents can make more informed decisions.
Our message to clinicians and parents is to reconsider the necessity and timing of ear tube surgery for children with recurrent ear infections because the future is not predicted by the past. Children having several ear infections in a short time does not predict that they will have a similar number of ear infections in the future.
The study was supported by the National Institutes of Health awarded to Rochester Regional Health. Dr. Pichichero was principal investigator for the award.
Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.
About half a million children between the ages of 1 and 3 years old have ear tube surgery in the United States every year at an annual cost exceeding $2 billion. It is the most common childhood surgery performed with anesthesia. It is a surgery commonly performed on children in most other high- and middle-income countries.
My group recently published a paper on the timing and necessity of tympanostomy tubes for recurrent otitis media in young children. The primary objective was to quantitatively examine recurrent acute otitis media (AOM) incidence with respect to age of occurrence, the influence of daycare attendance, and other risk factors in individual children. We introduced the concept of a “window of susceptibility” to AOM as new terminology referring to a child who has two or more closely spaced AOM occurrences during a window of time. We sought to know what to expect and how to advise the parent when a child presents with closely spaced AOMs.
A secondary objective was to develop models to predict the risk and timing of AOM recurrences based on the natural history of disease in young children who do not get tympanostomy tubes. Prediction models were developed to assist clinicians in understanding and explaining to parents the benefit of tympanostomy tubes based on the child’s age and number of AOMs.
The children were all from a primary care pediatric practice in Rochester, N.Y., which comprised a typical mixed demographic of largely middle-class, health care–insured families that was broadly representative of the racial/ethnic diversity in the community. The sample included both wealthy families and those living below the poverty line. The diagnosis of AOM was made based on the American Academy of Pediatrics guidance in which a presumed middle ear effusion and a full or bulging tympanic membrane were required. Almost all episodes (> 85%) of clinically diagnosed AOM cases were confirmed by culture of middle ear fluid collected by tympanocentesis to ensure diagnostic accuracy.
286 children who had ear infections were studied. We found that 80% of ear infections occurred during a very narrow window of susceptibility – age 6-21 months. About 72% of children had a window of susceptibility to ear infections that lasted 5 months or less; 97% of children had a window of susceptibility that lasted 10 months or less.
From this result, we observed that about 90% of children have a window of time lasting about 10 months when they get repeated ear infections. By the time a child gets three ear infections in 6 months (a period of time recommended by the AAP and American Academy of Otolaryngology–Head and Neck Surgery when ear tubes might be considered) and then a referral for ear tubes is made and the child gets an appointment with the ear, nose, and throat doctor, and surgery is scheduled, the ear infections were going to stop anyway.
In other words, millions of children worldwide have been getting ear tubes and physicians and parents saw that the ear infections stopped. So they concluded the ear tubes stopped the infections. We found the infections were going to stop anyway even if the child did not receive ear tubes because their susceptibility to ear infections is over by the time the surgery is performed. The child outgrew ear infections.
An exception was children in daycare at an early age. Our study found that children in daycare who are around 6 months old and start getting ear infections at that age are likely destined to have three or more ear infections in the first year of life. If children are going to be in daycare, perhaps those who need them should receive ear tubes early. Analysis of other demographic and risk factor covariates – sex, race/ethnicity, breastfeeding, siblings in the home, smoking in the home, atopy, and family history of otitis media – were not significantly associated with the number of AOMs in the child population we studied.
We developed a prediction model for doctors, so they could input a child’s age, number of ear infections, and daycare attendance and receive back an estimate of the number of likely future ear infections for that child. With that knowledge, physicians and parents can make more informed decisions.
Our message to clinicians and parents is to reconsider the necessity and timing of ear tube surgery for children with recurrent ear infections because the future is not predicted by the past. Children having several ear infections in a short time does not predict that they will have a similar number of ear infections in the future.
The study was supported by the National Institutes of Health awarded to Rochester Regional Health. Dr. Pichichero was principal investigator for the award.
Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.
A new (old) drug joins the COVID fray, and guess what? It works
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
At this point, with the monoclonals found to be essentially useless, we are left with remdesivir with its modest efficacy and Paxlovid, which, for some reason, people don’t seem to be taking.
Part of the reason the monoclonals have failed lately is because of their specificity; they are homogeneous antibodies targeted toward a very specific epitope that may change from variant to variant. We need a broader therapeutic, one that has activity across all variants — maybe even one that has activity against all viruses? We’ve got one. Interferon.
The first mention of interferon as a potential COVID therapy was at the very start of the pandemic, so I’m sort of surprised that the first large, randomized trial is only being reported now in the New England Journal of Medicine.
Before we dig into the results, let’s talk mechanism. This is a trial of interferon-lambda, also known as interleukin-29.
The lambda interferons were only discovered in 2003. They differ from the more familiar interferons only in their cellular receptors; the downstream effects seem quite similar. As opposed to the cellular receptors for interferon alfa, which are widely expressed, the receptors for lambda are restricted to epithelial tissues. This makes it a good choice as a COVID treatment, since the virus also preferentially targets those epithelial cells.
In this study, 1,951 participants from Brazil and Canada, but mostly Brazil, with new COVID infections who were not yet hospitalized were randomized to receive 180 mcg of interferon lambda or placebo.
This was a relatively current COVID trial, as you can see from the participant characteristics. The majority had been vaccinated, and nearly half of the infections were during the Omicron phase of the pandemic.
If you just want to cut to the chase, interferon worked.
The primary outcome – hospitalization or a prolonged emergency room visit for COVID – was 50% lower in the interferon group.
Key secondary outcomes, including death from COVID, were lower in the interferon group as well. These effects persisted across most of the subgroups I was looking out for.
Interferon seemed to help those who were already vaccinated and those who were unvaccinated. There’s a hint that it works better within the first few days of symptoms, which isn’t surprising; we’ve seen this for many of the therapeutics, including Paxlovid. Time is of the essence. Encouragingly, the effect was a bit more pronounced among those infected with Omicron.
Of course, if you have any experience with interferon, you know that the side effects can be pretty rough. In the bad old days when we treated hepatitis C infection with interferon, patients would get their injections on Friday in anticipation of being essentially out of commission with flu-like symptoms through the weekend. But we don’t see much evidence of adverse events in this trial, maybe due to the greater specificity of interferon lambda.
Putting it all together, the state of play for interferons in COVID may be changing. To date, the FDA has not recommended the use of interferon alfa or -beta for COVID-19, citing some data that they are ineffective or even harmful in hospitalized patients with COVID. Interferon lambda is not FDA approved and thus not even available in the United States. But the reason it has not been approved is that there has not been a large, well-conducted interferon lambda trial. Now there is. Will this study be enough to prompt an emergency use authorization? The elephant in the room, of course, is Paxlovid, which at this point has a longer safety track record and, importantly, is oral. I’d love to see a head-to-head trial. Short of that, I tend to be in favor of having more options on the table.
Dr. Perry Wilson is associate professor, department of medicine, and director, Clinical and Translational Research Accelerator, at Yale University, New Haven, Conn. He disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
At this point, with the monoclonals found to be essentially useless, we are left with remdesivir with its modest efficacy and Paxlovid, which, for some reason, people don’t seem to be taking.
Part of the reason the monoclonals have failed lately is because of their specificity; they are homogeneous antibodies targeted toward a very specific epitope that may change from variant to variant. We need a broader therapeutic, one that has activity across all variants — maybe even one that has activity against all viruses? We’ve got one. Interferon.
The first mention of interferon as a potential COVID therapy was at the very start of the pandemic, so I’m sort of surprised that the first large, randomized trial is only being reported now in the New England Journal of Medicine.
Before we dig into the results, let’s talk mechanism. This is a trial of interferon-lambda, also known as interleukin-29.
The lambda interferons were only discovered in 2003. They differ from the more familiar interferons only in their cellular receptors; the downstream effects seem quite similar. As opposed to the cellular receptors for interferon alfa, which are widely expressed, the receptors for lambda are restricted to epithelial tissues. This makes it a good choice as a COVID treatment, since the virus also preferentially targets those epithelial cells.
In this study, 1,951 participants from Brazil and Canada, but mostly Brazil, with new COVID infections who were not yet hospitalized were randomized to receive 180 mcg of interferon lambda or placebo.
This was a relatively current COVID trial, as you can see from the participant characteristics. The majority had been vaccinated, and nearly half of the infections were during the Omicron phase of the pandemic.
If you just want to cut to the chase, interferon worked.
The primary outcome – hospitalization or a prolonged emergency room visit for COVID – was 50% lower in the interferon group.
Key secondary outcomes, including death from COVID, were lower in the interferon group as well. These effects persisted across most of the subgroups I was looking out for.
Interferon seemed to help those who were already vaccinated and those who were unvaccinated. There’s a hint that it works better within the first few days of symptoms, which isn’t surprising; we’ve seen this for many of the therapeutics, including Paxlovid. Time is of the essence. Encouragingly, the effect was a bit more pronounced among those infected with Omicron.
Of course, if you have any experience with interferon, you know that the side effects can be pretty rough. In the bad old days when we treated hepatitis C infection with interferon, patients would get their injections on Friday in anticipation of being essentially out of commission with flu-like symptoms through the weekend. But we don’t see much evidence of adverse events in this trial, maybe due to the greater specificity of interferon lambda.
Putting it all together, the state of play for interferons in COVID may be changing. To date, the FDA has not recommended the use of interferon alfa or -beta for COVID-19, citing some data that they are ineffective or even harmful in hospitalized patients with COVID. Interferon lambda is not FDA approved and thus not even available in the United States. But the reason it has not been approved is that there has not been a large, well-conducted interferon lambda trial. Now there is. Will this study be enough to prompt an emergency use authorization? The elephant in the room, of course, is Paxlovid, which at this point has a longer safety track record and, importantly, is oral. I’d love to see a head-to-head trial. Short of that, I tend to be in favor of having more options on the table.
Dr. Perry Wilson is associate professor, department of medicine, and director, Clinical and Translational Research Accelerator, at Yale University, New Haven, Conn. He disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
At this point, with the monoclonals found to be essentially useless, we are left with remdesivir with its modest efficacy and Paxlovid, which, for some reason, people don’t seem to be taking.
Part of the reason the monoclonals have failed lately is because of their specificity; they are homogeneous antibodies targeted toward a very specific epitope that may change from variant to variant. We need a broader therapeutic, one that has activity across all variants — maybe even one that has activity against all viruses? We’ve got one. Interferon.
The first mention of interferon as a potential COVID therapy was at the very start of the pandemic, so I’m sort of surprised that the first large, randomized trial is only being reported now in the New England Journal of Medicine.
Before we dig into the results, let’s talk mechanism. This is a trial of interferon-lambda, also known as interleukin-29.
The lambda interferons were only discovered in 2003. They differ from the more familiar interferons only in their cellular receptors; the downstream effects seem quite similar. As opposed to the cellular receptors for interferon alfa, which are widely expressed, the receptors for lambda are restricted to epithelial tissues. This makes it a good choice as a COVID treatment, since the virus also preferentially targets those epithelial cells.
In this study, 1,951 participants from Brazil and Canada, but mostly Brazil, with new COVID infections who were not yet hospitalized were randomized to receive 180 mcg of interferon lambda or placebo.
This was a relatively current COVID trial, as you can see from the participant characteristics. The majority had been vaccinated, and nearly half of the infections were during the Omicron phase of the pandemic.
If you just want to cut to the chase, interferon worked.
The primary outcome – hospitalization or a prolonged emergency room visit for COVID – was 50% lower in the interferon group.
Key secondary outcomes, including death from COVID, were lower in the interferon group as well. These effects persisted across most of the subgroups I was looking out for.
Interferon seemed to help those who were already vaccinated and those who were unvaccinated. There’s a hint that it works better within the first few days of symptoms, which isn’t surprising; we’ve seen this for many of the therapeutics, including Paxlovid. Time is of the essence. Encouragingly, the effect was a bit more pronounced among those infected with Omicron.
Of course, if you have any experience with interferon, you know that the side effects can be pretty rough. In the bad old days when we treated hepatitis C infection with interferon, patients would get their injections on Friday in anticipation of being essentially out of commission with flu-like symptoms through the weekend. But we don’t see much evidence of adverse events in this trial, maybe due to the greater specificity of interferon lambda.
Putting it all together, the state of play for interferons in COVID may be changing. To date, the FDA has not recommended the use of interferon alfa or -beta for COVID-19, citing some data that they are ineffective or even harmful in hospitalized patients with COVID. Interferon lambda is not FDA approved and thus not even available in the United States. But the reason it has not been approved is that there has not been a large, well-conducted interferon lambda trial. Now there is. Will this study be enough to prompt an emergency use authorization? The elephant in the room, of course, is Paxlovid, which at this point has a longer safety track record and, importantly, is oral. I’d love to see a head-to-head trial. Short of that, I tend to be in favor of having more options on the table.
Dr. Perry Wilson is associate professor, department of medicine, and director, Clinical and Translational Research Accelerator, at Yale University, New Haven, Conn. He disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Pound of flesh buys less prison time
Pound of flesh buys less prison time
We should all have more Shakespeare in our lives. Yeah, yeah, Shakespeare is meant to be played, not read, and it can be a struggle to herd teenagers through the Bard’s interesting and bloody tragedies, but even a perfunctory reading of “The Merchant of Venice” would hopefully have prevented the dystopian nightmare Massachusetts has presented us with today.
The United States has a massive shortage of donor organs. This is an unfortunate truth. So, to combat this issue, a pair of Massachusetts congresspeople have proposed HD 3822, which would allow prisoners to donate organs and/or bone marrow (a pound of flesh, so to speak) in exchange for up to a year in reduced prison time. Yes, that’s right. Give up pieces of yourself and the state of Massachusetts will deign to reduce your long prison sentence.
Oh, and before you dismiss this as typical Republican antics, the bill was sponsored by two Democrats, and in a statement one of them hoped to address racial disparities in organ donation, as people of color are much less likely to receive organs. Never mind that Black people are imprisoned at a much higher rate than Whites.
Yeah, this whole thing is what people in the business like to call an ethical disaster.
Fortunately, the bill will likely never be passed and it’s probably illegal anyway. A federal law from 1984 (how’s that for a coincidence) prevents people from donating organs for use in human transplantation in exchange for “valuable consideration.” In other words, you can’t sell your organs for profit, and in this case, reducing prison time would probably count as valuable consideration in the eyes of the courts.
Oh, and in case you’ve never read Merchant of Venice, Shylock, the character looking for the pound of flesh as payment for a debt? He’s the villain. In fact, it’s pretty safe to say that anyone looking to extract payment from human dismemberment is probably the bad guy of the story. Apparently that wasn’t clear.
How do you stop a fungi? With a deadly guy
Thanks to the new HBO series “The Last of Us,” there’s been a lot of talk about the upcoming fungi-pocalypse, as the show depicts the real-life “zombie fungus” Cordyceps turning humans into, you know, zombies.
No need to worry, ladies and gentleman, because science has discovered a way to turn back the fungal horde. A heroic, and environmentally friendly, alternative to chemical pesticides “in the fight against resistant fungi [that] are now resistant to antimycotics – partly because they are used in large quantities in agricultural fields,” investigators at the Leibniz Institute for Natural Product Research and Infection Biology in Jena, Germany, said in a written statement.
We are, of course, talking about Keanu Reeves. Wait a second. He’s not even in “The Last of Us.” Sorry folks, we are being told that it really is Keanu Reeves. Our champion in the inevitable fungal pandemic is movie star Keanu Reeves. Sort of. It’s actually keanumycin, a substance produced by bacteria of the genus Pseudomonas.
Really? Keanumycin? “The lipopeptides kill so efficiently that we named them after Keanu Reeves because he, too, is extremely deadly in his roles,” lead author Sebastian Götze, PhD, explained.
Dr. Götze and his associates had been working with pseudomonads for quite a while before they were able to isolate the toxins responsible for their ability to kill amoebae, which resemble fungi in some characteristics. When then finally tried the keanumycin against gray mold rot on hydrangea leaves, the intensely contemplative star of “The Matrix” and “John Wick” – sorry, wrong Keanu – the bacterial derivative significantly inhibited growth of the fungus, they said.
Additional testing has shown that keanumycin is not highly toxic to human cells and is effective against fungi such as Candida albicans in very low concentrations, which makes it a good candidate for future pharmaceutical development.
To that news there can be only one response from the substance’s namesake.
High fat, bye parasites
Fat. Fat. Fat. Seems like everyone is trying to avoid it these days, but fat may be good thing when it comes to weaseling out a parasite.
The parasite in this case is the whipworm, aka Trichuris trichiura. You can find this guy in the intestines of millions of people, where it causes long-lasting infections. Yikes … Researchers have found that the plan of attack to get rid of this invasive species is to boost the immune system, but instead of vitamin C and zinc it’s fat they’re pumping in. Yes, fat.
The developing countries with poor sewage that are at the highest risk for contracting parasites such as this also are among those where people ingest cheaper diets that are generally higher in fat. The investigators were interested to see how a high-fat diet would affect immune responses to the whipworms.
And, as with almost everything else, the researchers turned to mice, which were introduced to a closely related species, Trichuris muris.
A high-fat diet, rather than obesity itself, increases a molecule on T-helper cells called ST2, and this allows an increased T-helper 2 response, effectively giving eviction notices to the parasites in the intestinal lining.
To say the least, the researchers were surprised since “high-fat diets are mostly associated with increased pathology during disease,” said senior author Richard Grencis, PhD, of the University of Manchester (England), who noted that ST2 is not normally triggered with a standard diet in mice but the high-fat diet gave it a boost and an “alternate pathway” out.
Now before you start ordering extra-large fries at the drive-through to keep the whipworms away, the researchers added that they “have previously published that weight loss can aid the expulsion of a different gut parasite worm.” Figures.
Once again, though, signs are pointing to the gut for improved health.
Pound of flesh buys less prison time
We should all have more Shakespeare in our lives. Yeah, yeah, Shakespeare is meant to be played, not read, and it can be a struggle to herd teenagers through the Bard’s interesting and bloody tragedies, but even a perfunctory reading of “The Merchant of Venice” would hopefully have prevented the dystopian nightmare Massachusetts has presented us with today.
The United States has a massive shortage of donor organs. This is an unfortunate truth. So, to combat this issue, a pair of Massachusetts congresspeople have proposed HD 3822, which would allow prisoners to donate organs and/or bone marrow (a pound of flesh, so to speak) in exchange for up to a year in reduced prison time. Yes, that’s right. Give up pieces of yourself and the state of Massachusetts will deign to reduce your long prison sentence.
Oh, and before you dismiss this as typical Republican antics, the bill was sponsored by two Democrats, and in a statement one of them hoped to address racial disparities in organ donation, as people of color are much less likely to receive organs. Never mind that Black people are imprisoned at a much higher rate than Whites.
Yeah, this whole thing is what people in the business like to call an ethical disaster.
Fortunately, the bill will likely never be passed and it’s probably illegal anyway. A federal law from 1984 (how’s that for a coincidence) prevents people from donating organs for use in human transplantation in exchange for “valuable consideration.” In other words, you can’t sell your organs for profit, and in this case, reducing prison time would probably count as valuable consideration in the eyes of the courts.
Oh, and in case you’ve never read Merchant of Venice, Shylock, the character looking for the pound of flesh as payment for a debt? He’s the villain. In fact, it’s pretty safe to say that anyone looking to extract payment from human dismemberment is probably the bad guy of the story. Apparently that wasn’t clear.
How do you stop a fungi? With a deadly guy
Thanks to the new HBO series “The Last of Us,” there’s been a lot of talk about the upcoming fungi-pocalypse, as the show depicts the real-life “zombie fungus” Cordyceps turning humans into, you know, zombies.
No need to worry, ladies and gentleman, because science has discovered a way to turn back the fungal horde. A heroic, and environmentally friendly, alternative to chemical pesticides “in the fight against resistant fungi [that] are now resistant to antimycotics – partly because they are used in large quantities in agricultural fields,” investigators at the Leibniz Institute for Natural Product Research and Infection Biology in Jena, Germany, said in a written statement.
We are, of course, talking about Keanu Reeves. Wait a second. He’s not even in “The Last of Us.” Sorry folks, we are being told that it really is Keanu Reeves. Our champion in the inevitable fungal pandemic is movie star Keanu Reeves. Sort of. It’s actually keanumycin, a substance produced by bacteria of the genus Pseudomonas.
Really? Keanumycin? “The lipopeptides kill so efficiently that we named them after Keanu Reeves because he, too, is extremely deadly in his roles,” lead author Sebastian Götze, PhD, explained.
Dr. Götze and his associates had been working with pseudomonads for quite a while before they were able to isolate the toxins responsible for their ability to kill amoebae, which resemble fungi in some characteristics. When then finally tried the keanumycin against gray mold rot on hydrangea leaves, the intensely contemplative star of “The Matrix” and “John Wick” – sorry, wrong Keanu – the bacterial derivative significantly inhibited growth of the fungus, they said.
Additional testing has shown that keanumycin is not highly toxic to human cells and is effective against fungi such as Candida albicans in very low concentrations, which makes it a good candidate for future pharmaceutical development.
To that news there can be only one response from the substance’s namesake.
High fat, bye parasites
Fat. Fat. Fat. Seems like everyone is trying to avoid it these days, but fat may be good thing when it comes to weaseling out a parasite.
The parasite in this case is the whipworm, aka Trichuris trichiura. You can find this guy in the intestines of millions of people, where it causes long-lasting infections. Yikes … Researchers have found that the plan of attack to get rid of this invasive species is to boost the immune system, but instead of vitamin C and zinc it’s fat they’re pumping in. Yes, fat.
The developing countries with poor sewage that are at the highest risk for contracting parasites such as this also are among those where people ingest cheaper diets that are generally higher in fat. The investigators were interested to see how a high-fat diet would affect immune responses to the whipworms.
And, as with almost everything else, the researchers turned to mice, which were introduced to a closely related species, Trichuris muris.
A high-fat diet, rather than obesity itself, increases a molecule on T-helper cells called ST2, and this allows an increased T-helper 2 response, effectively giving eviction notices to the parasites in the intestinal lining.
To say the least, the researchers were surprised since “high-fat diets are mostly associated with increased pathology during disease,” said senior author Richard Grencis, PhD, of the University of Manchester (England), who noted that ST2 is not normally triggered with a standard diet in mice but the high-fat diet gave it a boost and an “alternate pathway” out.
Now before you start ordering extra-large fries at the drive-through to keep the whipworms away, the researchers added that they “have previously published that weight loss can aid the expulsion of a different gut parasite worm.” Figures.
Once again, though, signs are pointing to the gut for improved health.
Pound of flesh buys less prison time
We should all have more Shakespeare in our lives. Yeah, yeah, Shakespeare is meant to be played, not read, and it can be a struggle to herd teenagers through the Bard’s interesting and bloody tragedies, but even a perfunctory reading of “The Merchant of Venice” would hopefully have prevented the dystopian nightmare Massachusetts has presented us with today.
The United States has a massive shortage of donor organs. This is an unfortunate truth. So, to combat this issue, a pair of Massachusetts congresspeople have proposed HD 3822, which would allow prisoners to donate organs and/or bone marrow (a pound of flesh, so to speak) in exchange for up to a year in reduced prison time. Yes, that’s right. Give up pieces of yourself and the state of Massachusetts will deign to reduce your long prison sentence.
Oh, and before you dismiss this as typical Republican antics, the bill was sponsored by two Democrats, and in a statement one of them hoped to address racial disparities in organ donation, as people of color are much less likely to receive organs. Never mind that Black people are imprisoned at a much higher rate than Whites.
Yeah, this whole thing is what people in the business like to call an ethical disaster.
Fortunately, the bill will likely never be passed and it’s probably illegal anyway. A federal law from 1984 (how’s that for a coincidence) prevents people from donating organs for use in human transplantation in exchange for “valuable consideration.” In other words, you can’t sell your organs for profit, and in this case, reducing prison time would probably count as valuable consideration in the eyes of the courts.
Oh, and in case you’ve never read Merchant of Venice, Shylock, the character looking for the pound of flesh as payment for a debt? He’s the villain. In fact, it’s pretty safe to say that anyone looking to extract payment from human dismemberment is probably the bad guy of the story. Apparently that wasn’t clear.
How do you stop a fungi? With a deadly guy
Thanks to the new HBO series “The Last of Us,” there’s been a lot of talk about the upcoming fungi-pocalypse, as the show depicts the real-life “zombie fungus” Cordyceps turning humans into, you know, zombies.
No need to worry, ladies and gentleman, because science has discovered a way to turn back the fungal horde. A heroic, and environmentally friendly, alternative to chemical pesticides “in the fight against resistant fungi [that] are now resistant to antimycotics – partly because they are used in large quantities in agricultural fields,” investigators at the Leibniz Institute for Natural Product Research and Infection Biology in Jena, Germany, said in a written statement.
We are, of course, talking about Keanu Reeves. Wait a second. He’s not even in “The Last of Us.” Sorry folks, we are being told that it really is Keanu Reeves. Our champion in the inevitable fungal pandemic is movie star Keanu Reeves. Sort of. It’s actually keanumycin, a substance produced by bacteria of the genus Pseudomonas.
Really? Keanumycin? “The lipopeptides kill so efficiently that we named them after Keanu Reeves because he, too, is extremely deadly in his roles,” lead author Sebastian Götze, PhD, explained.
Dr. Götze and his associates had been working with pseudomonads for quite a while before they were able to isolate the toxins responsible for their ability to kill amoebae, which resemble fungi in some characteristics. When then finally tried the keanumycin against gray mold rot on hydrangea leaves, the intensely contemplative star of “The Matrix” and “John Wick” – sorry, wrong Keanu – the bacterial derivative significantly inhibited growth of the fungus, they said.
Additional testing has shown that keanumycin is not highly toxic to human cells and is effective against fungi such as Candida albicans in very low concentrations, which makes it a good candidate for future pharmaceutical development.
To that news there can be only one response from the substance’s namesake.
High fat, bye parasites
Fat. Fat. Fat. Seems like everyone is trying to avoid it these days, but fat may be good thing when it comes to weaseling out a parasite.
The parasite in this case is the whipworm, aka Trichuris trichiura. You can find this guy in the intestines of millions of people, where it causes long-lasting infections. Yikes … Researchers have found that the plan of attack to get rid of this invasive species is to boost the immune system, but instead of vitamin C and zinc it’s fat they’re pumping in. Yes, fat.
The developing countries with poor sewage that are at the highest risk for contracting parasites such as this also are among those where people ingest cheaper diets that are generally higher in fat. The investigators were interested to see how a high-fat diet would affect immune responses to the whipworms.
And, as with almost everything else, the researchers turned to mice, which were introduced to a closely related species, Trichuris muris.
A high-fat diet, rather than obesity itself, increases a molecule on T-helper cells called ST2, and this allows an increased T-helper 2 response, effectively giving eviction notices to the parasites in the intestinal lining.
To say the least, the researchers were surprised since “high-fat diets are mostly associated with increased pathology during disease,” said senior author Richard Grencis, PhD, of the University of Manchester (England), who noted that ST2 is not normally triggered with a standard diet in mice but the high-fat diet gave it a boost and an “alternate pathway” out.
Now before you start ordering extra-large fries at the drive-through to keep the whipworms away, the researchers added that they “have previously published that weight loss can aid the expulsion of a different gut parasite worm.” Figures.
Once again, though, signs are pointing to the gut for improved health.
Maternal COVID-19 vaccine curbs infant infection
a new study shows.
Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.
In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.
Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.
Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.
The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.
The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).
Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.
The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.
The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.
The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).
Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.
Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.
The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.
Effectiveness is encouraging, but updates are needed
The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.
They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.
Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.
The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.
Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.
“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.
*This article was updated on 3/2/2023.
a new study shows.
Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.
In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.
Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.
Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.
The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.
The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).
Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.
The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.
The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.
The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).
Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.
Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.
The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.
Effectiveness is encouraging, but updates are needed
The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.
They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.
Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.
The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.
Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.
“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.
*This article was updated on 3/2/2023.
a new study shows.
Previous research has confirmed that COVID-19 neutralizing antibodies following maternal vaccination or maternal COVID-19 infection are present in umbilical cord blood, breast milk, and infant serum specimens, wrote Sarah C.J. Jorgensen, PharmD, MPH, of the University of Toronto, and colleagues in their article published in The BMJ.
In the study, the researchers identified maternal and newborn pairs using administrative databases from Canada. The study population included 8,809 infants aged younger than 6 months who were born between May 7, 2021, and March 31, 2022, and who underwent testing for COVID-19 between May 7, 2021, and September 5, 2022.
Maternal vaccination with the primary COVID-19 mRNA monovalent vaccine series was defined as two vaccine doses administered up to 14 days before delivery, with at least one of the doses after the conception date.
Maternal vaccination with the primary series plus one booster was defined as three doses administered up to 14 days before delivery, with at least one of these doses after the conception date.
The primary outcome was the presence of delta or omicron COVID-19 infection or hospital admission of the infants.
The study population included 99 COVID-19 cases with the delta variant (with 4,365 controls) and 1,501 cases with the omicron variant (with 4,847 controls).
Overall, the vaccine effectiveness of maternal doses was 95% against delta infection and 45% against omicron.
The effectiveness against hospital admission in cases of delta and omicron variants were 97% and 53%, respectively.
The effectiveness of three doses was 73% against omicron infant infection and 80% against omicron-related infant hospitalization. Data were not available for the effectiveness of three doses against the delta variant.
The effectiveness of two doses of vaccine against infant omicron infection was highest when mothers received the second dose during the third trimester of pregnancy, compared with during the first trimester or second trimester (53% vs. 47% and 53% vs. 37%, respectively).
Vaccine effectiveness with two doses against infant infection from omicron was highest in the first 8 weeks of life (57%), then decreased to 40% among infants after 16 weeks of age.
Although the study was not designed to assess the mechanism of action of the impact of maternal vaccination on infants, the current study results were consistent with other recent studies showing a reduction in infections and hospitalizations among infants whose mothers received COVID-19 vaccines during pregnancy, the researchers wrote in their discussion.
The findings were limited by several factors including the potential unmeasured confounders not available in databases, such as whether infants were breastfed, the researchers noted. Other limitations included a lack of data on home test results and the inability to assess the waning impact of the vaccine effectiveness against the delta variant because of the small number of delta cases, they said. However, the results suggest that the mRNA COVID-19 vaccine during pregnancy was moderately to highly effective for protection against omicron and delta infection and infection-related hospitalization – especially during the first 8 weeks of life.
Effectiveness is encouraging, but updates are needed
The effectiveness of maternal vaccination to prevent COVID-19 infection and related hospitalizations in infants is promising, especially since those younger than 6 months have no other source of vaccine protection against COVID-19 infection, wrote Dana Danino, MD, of Soroka University Medical Center, Israel, and Ilan Youngster, MD, of Shamir Medical Center, Israel, in an accompanying editorial also published in The BMJ.
They also noted that maternal vaccination during pregnancy is an established method of protecting infants from infections such as influenza and pertussis.
Data from previous studies show that most infants whose mothers were vaccinated against COVID-19 during pregnancy retained maternal antibodies at 6 months, “but evidence for protection against neonatal COVID-19 infection has been deficient,” they said.
The current study findings support the value of vaccination during pregnancy, and the findings were strengthened by the large study population, the editorialists wrote. However, whether the same effectiveness holds for other COVID-19 strains such as BQ.1, BQ.1.1, BF.7, XBB, and XBB.1 remains unknown, they said.
Other areas in need of exploration include the optimal timing of vaccination during pregnancy, the protective effects of a bivalent mRNA vaccine (vs. the primary monovalent vaccine in the current study), and the potential benefits of additional boosters, they added.
“Although Jorgenson and colleagues’ study reinforces the value of maternal vaccination against COVID-19 during pregnancy, more studies are needed to better inform vaccination recommendations in an evolving landscape of new SARS-CoV-2 strains and novel vaccines,” the editorialists concluded.
The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-term Care; the study also received funding from the Canadian Immunization Research Network and the Public Health Agency of Canada. Dr. Jorgensen and the editorialists had no financial conflicts to disclose.
*This article was updated on 3/2/2023.
FROM THE BMJ
Infiltrating Wound Vacuum-Assisted Closure With Topical Amphotericin for Mucormycosis Infection of the Achilles Tendon
Vacuum-assisted closure (VAC) of wounds has become a foundational tool in the armamentarium of wound care specialists. Using a system consisting of a sponge, semi-occlusive barrier, and fluid collection device, VAC systems apply constant negative pressure resulting in macro and micro deformation to a wound, stabilization of the wound environment, and removal of inflammatory factors in wound fluid.1 These conditions allow for the removal of drainage and fluid from a wound bed, reduced edema and inflammation, reduced bacterial load, recruitment of healing factors, approximation of wound edges, and increased blood flow to the wound.2
In complex, infected wounds, a variation of negative pressure wound therapy (NPWT) via the instillation of topical antibiotics (instillation VAC) has been used.3 This variation has been advantageous even in soft tissue fungal infections. Early and aggressive treatment of such infections is critical to prevent dissemination, particularly in aggressive infections, such as mucormycosis.4 We present a case of a patient with a mucormycosis infection of his left Achilles tendon and overlying skin who was successfully treated with surgical debridement and wound care with instillation NPWT with topical amphotericin B.
Case Presentation
A 53-year-old man underwent left Achilles tendon reconstruction with allograft after a complete tear during exercise. He had no relevant medical history and was otherwise healthy, which he attributed to working out daily. About a week after the operation, he began having incisional breakdown, prompting presentation to an emergency department. There, he received IV antibiotics along with multiple debridements. After the wound failed to improve and intra-operative cultures grew mucormycosis, he was transferred to our facility for a higher level of care. On admission, he was immediately given IV amphotericin B and scheduled for repeat debridement.
After 1 prior debridement and 10 total days of IV amphotericin, a repeat debridement was performed. After the debridement, the installation VAC was applied to the patient’s left lower extremity wound with an instilling fluid of amphotericin B and the settings as follows: smart phase instill volume, 110 mL; soak time, 3.5 hours; target pressure, 125 mm Hg; intensity, low; and VAC therapy mode, continuous. After 5 days, the wound bed appeared clean without overt signs of infection. However, due to some toxicity to healthy surrounding soft tissue, the instillation VAC was discontinued and standard NPWT was started. The patient underwent 2 additional rounds of debridement with partial delayed closure. Four weeks after discontinuation of the instillation VAC, the wound appeared healthy and granulated so the patient underwent split-thickness skin grafting to the left posterior ankle. He subsequently completed a course of oral antifungal medication as an outpatient.
The patient was seen in the outpatient clinic for 14 months from the initial mucormycosis infection (Figure). 
Discussion
Mucormycosis is an infection caused by fungi in the class Zygomycetes and of the order Mucorales that typically occurs in immunocompromised patients, especially those with diabetic ketoacidosis and neutropenia. Given that this patient had no relevant medical history and was otherwise healthy, he was at extremely low risk of this type of infection. In this patient’s case, the spores of this nonseptate hyphae wide-branching species were most likely introduced at the time of left Achilles tendon repair. Mucormycosis is progressive and can be fatal unless treated, with a mortality rate approaching 70%.5 The rarity and heterogeneity of mucormycosis make treatment variable.6 No prospective or randomized clinical trials exist in plastic surgery literature.
The use of wound VAC in combination with the instillation of amphotericin B to treat cutaneous mucormycosis is not well documented. Mucormycosis infections are traditionally addressed with surgical debridement and antifungal therapy, specifically IV amphotericin B.7,8 As previously noted, NPWT has become the gold standard in treating complex wounds.3 Additionally, wound VAC therapy with instillation has been noted in the literature as a reliable method to treat bacteria-infected wounds, providing a shorter treatment period and earlier wound closure.9 Instillation VAC therapy has proven particularly useful in complex, infected wounds, such as aggressive fungal infections.
Mucormycosis treatment is challenging particularly in the extremities as management must balance both mortality and limb salvage. In this case, the use of NPWT with wound VAC and intervals of instilling amphotericin B facilitated infection control in this lower extremity mucormycosis infection. The significant adverse effect profile of amphotericin B, particularly the nephrotoxicity, should be seriously considered when deciding the treatment regimen for patients affected by mucormycosis. Locally, topical amphotericin B has been reported to cause blistering, itchiness, redness, peeling, and dryness. However, topical preparations of amphotericin B are nontoxic unlike their IV counterpart, able to cross the physiological barriers of the skin while simultaneously targeting macrophages in the dermis and epidermis.10
Conclusions
Although the mainstay of treatment for systemic mucormycosis is radical debridement and IV amphotericin B, a more localized infection may benefit from an adjunct like an instillation wound VAC with topical amphotericin B, as presented in this case study. Swift treatment with wound VAC was beneficial in the overall recovery and tissue healing of this patient and may be beneficial in similar cases.
1. Normandin S, Safran T, Winocour S, et al. negative pressure wound therapy: mechanism of action and clinical applications. Semin Plast Surg. 2021;35(3):164-170. doi:10.1055/s-0041-1731792
2. Agarwal P, Kukrele R, Sharma D. Vacuum assisted closure (VAC)/negative pressure wound therapy (NPWT) for difficult wounds: a review. J Clin Orthop Trauma. 2019;10(5):845-848. doi:10.1016/j.jcot.2019.06.015
3. Gabriel A, Shores J, Bernstein B, et al. A clinical review of infected wound treatment with Vacuum Assisted Closure (V.A.C.) therapy: experience and case series. Int Wound J. 2009;6(suppl 2):1-25. doi:10.1111/j.1742-481X.2009.00628.x
4. Guégan S, Lanternier F, Rouzaud C, Dupin N, Lortholary O. Fungal skin and soft tissue infections. Curr Opin Infect Dis. 2016;29(2):124-130. doi:10.1097/QCO.0000000000000252
5. Ibrahim AS, Spellberg B, Walsh TJ, Kontoyiannis DP. Pathogenesis of mucormycosis. Clin Infect Dis. 2012;54(suppl 1):S16-S22. doi:10.1093/cid/cir865
6. Sipsas NV, Gamaletsou MN, Anastasopoulou A, Kontoyiannis DP. Therapy of mucormycosis. J Fungi (Basel). 2018;4(3):90. Published 2018 Jul 31. doi:10.3390/jof4030090
7. Spellberg B, Edwards J Jr, Ibrahim A. Novel perspectives on mucormycosis: pathophysiology, presentation, and management. Clin Microbiol Rev. 2005;18(3):556-569. doi:10.1128/CMR.18.3.556-569.2005
8. Losee JE, Selber J, Vega S, Hall C, Scott G, Serletti JM. Primary cutaneous mucormycosis: guide to surgical management. Ann Plast Surg. 2002;49(4):385-390. doi:10.1097/00000637-200210000-00009
9. Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002;10(5):303-311. doi:10.5435/00124635-200209000-00002
10. Varikuti S, Oghumu S, Saljoughian N, et al. Topical treatment with nanoliposomal Amphotericin B reduces early lesion growth but fails to induce cure in an experimental model of cutaneous leishmaniasis caused by Leishmania mexicana. Acta Trop. 2017;173:102-108. doi:10.1016/j.actatropica.2017.06.004
Vacuum-assisted closure (VAC) of wounds has become a foundational tool in the armamentarium of wound care specialists. Using a system consisting of a sponge, semi-occlusive barrier, and fluid collection device, VAC systems apply constant negative pressure resulting in macro and micro deformation to a wound, stabilization of the wound environment, and removal of inflammatory factors in wound fluid.1 These conditions allow for the removal of drainage and fluid from a wound bed, reduced edema and inflammation, reduced bacterial load, recruitment of healing factors, approximation of wound edges, and increased blood flow to the wound.2
In complex, infected wounds, a variation of negative pressure wound therapy (NPWT) via the instillation of topical antibiotics (instillation VAC) has been used.3 This variation has been advantageous even in soft tissue fungal infections. Early and aggressive treatment of such infections is critical to prevent dissemination, particularly in aggressive infections, such as mucormycosis.4 We present a case of a patient with a mucormycosis infection of his left Achilles tendon and overlying skin who was successfully treated with surgical debridement and wound care with instillation NPWT with topical amphotericin B.
Case Presentation
A 53-year-old man underwent left Achilles tendon reconstruction with allograft after a complete tear during exercise. He had no relevant medical history and was otherwise healthy, which he attributed to working out daily. About a week after the operation, he began having incisional breakdown, prompting presentation to an emergency department. There, he received IV antibiotics along with multiple debridements. After the wound failed to improve and intra-operative cultures grew mucormycosis, he was transferred to our facility for a higher level of care. On admission, he was immediately given IV amphotericin B and scheduled for repeat debridement.
After 1 prior debridement and 10 total days of IV amphotericin, a repeat debridement was performed. After the debridement, the installation VAC was applied to the patient’s left lower extremity wound with an instilling fluid of amphotericin B and the settings as follows: smart phase instill volume, 110 mL; soak time, 3.5 hours; target pressure, 125 mm Hg; intensity, low; and VAC therapy mode, continuous. After 5 days, the wound bed appeared clean without overt signs of infection. However, due to some toxicity to healthy surrounding soft tissue, the instillation VAC was discontinued and standard NPWT was started. The patient underwent 2 additional rounds of debridement with partial delayed closure. Four weeks after discontinuation of the instillation VAC, the wound appeared healthy and granulated so the patient underwent split-thickness skin grafting to the left posterior ankle. He subsequently completed a course of oral antifungal medication as an outpatient.
The patient was seen in the outpatient clinic for 14 months from the initial mucormycosis infection (Figure).
Discussion
Mucormycosis is an infection caused by fungi in the class Zygomycetes and of the order Mucorales that typically occurs in immunocompromised patients, especially those with diabetic ketoacidosis and neutropenia. Given that this patient had no relevant medical history and was otherwise healthy, he was at extremely low risk of this type of infection. In this patient’s case, the spores of this nonseptate hyphae wide-branching species were most likely introduced at the time of left Achilles tendon repair. Mucormycosis is progressive and can be fatal unless treated, with a mortality rate approaching 70%.5 The rarity and heterogeneity of mucormycosis make treatment variable.6 No prospective or randomized clinical trials exist in plastic surgery literature.
The use of wound VAC in combination with the instillation of amphotericin B to treat cutaneous mucormycosis is not well documented. Mucormycosis infections are traditionally addressed with surgical debridement and antifungal therapy, specifically IV amphotericin B.7,8 As previously noted, NPWT has become the gold standard in treating complex wounds.3 Additionally, wound VAC therapy with instillation has been noted in the literature as a reliable method to treat bacteria-infected wounds, providing a shorter treatment period and earlier wound closure.9 Instillation VAC therapy has proven particularly useful in complex, infected wounds, such as aggressive fungal infections.
Mucormycosis treatment is challenging particularly in the extremities as management must balance both mortality and limb salvage. In this case, the use of NPWT with wound VAC and intervals of instilling amphotericin B facilitated infection control in this lower extremity mucormycosis infection. The significant adverse effect profile of amphotericin B, particularly the nephrotoxicity, should be seriously considered when deciding the treatment regimen for patients affected by mucormycosis. Locally, topical amphotericin B has been reported to cause blistering, itchiness, redness, peeling, and dryness. However, topical preparations of amphotericin B are nontoxic unlike their IV counterpart, able to cross the physiological barriers of the skin while simultaneously targeting macrophages in the dermis and epidermis.10
Conclusions
Although the mainstay of treatment for systemic mucormycosis is radical debridement and IV amphotericin B, a more localized infection may benefit from an adjunct like an instillation wound VAC with topical amphotericin B, as presented in this case study. Swift treatment with wound VAC was beneficial in the overall recovery and tissue healing of this patient and may be beneficial in similar cases.
Vacuum-assisted closure (VAC) of wounds has become a foundational tool in the armamentarium of wound care specialists. Using a system consisting of a sponge, semi-occlusive barrier, and fluid collection device, VAC systems apply constant negative pressure resulting in macro and micro deformation to a wound, stabilization of the wound environment, and removal of inflammatory factors in wound fluid.1 These conditions allow for the removal of drainage and fluid from a wound bed, reduced edema and inflammation, reduced bacterial load, recruitment of healing factors, approximation of wound edges, and increased blood flow to the wound.2
In complex, infected wounds, a variation of negative pressure wound therapy (NPWT) via the instillation of topical antibiotics (instillation VAC) has been used.3 This variation has been advantageous even in soft tissue fungal infections. Early and aggressive treatment of such infections is critical to prevent dissemination, particularly in aggressive infections, such as mucormycosis.4 We present a case of a patient with a mucormycosis infection of his left Achilles tendon and overlying skin who was successfully treated with surgical debridement and wound care with instillation NPWT with topical amphotericin B.
Case Presentation
A 53-year-old man underwent left Achilles tendon reconstruction with allograft after a complete tear during exercise. He had no relevant medical history and was otherwise healthy, which he attributed to working out daily. About a week after the operation, he began having incisional breakdown, prompting presentation to an emergency department. There, he received IV antibiotics along with multiple debridements. After the wound failed to improve and intra-operative cultures grew mucormycosis, he was transferred to our facility for a higher level of care. On admission, he was immediately given IV amphotericin B and scheduled for repeat debridement.
After 1 prior debridement and 10 total days of IV amphotericin, a repeat debridement was performed. After the debridement, the installation VAC was applied to the patient’s left lower extremity wound with an instilling fluid of amphotericin B and the settings as follows: smart phase instill volume, 110 mL; soak time, 3.5 hours; target pressure, 125 mm Hg; intensity, low; and VAC therapy mode, continuous. After 5 days, the wound bed appeared clean without overt signs of infection. However, due to some toxicity to healthy surrounding soft tissue, the instillation VAC was discontinued and standard NPWT was started. The patient underwent 2 additional rounds of debridement with partial delayed closure. Four weeks after discontinuation of the instillation VAC, the wound appeared healthy and granulated so the patient underwent split-thickness skin grafting to the left posterior ankle. He subsequently completed a course of oral antifungal medication as an outpatient.
The patient was seen in the outpatient clinic for 14 months from the initial mucormycosis infection (Figure).
Discussion
Mucormycosis is an infection caused by fungi in the class Zygomycetes and of the order Mucorales that typically occurs in immunocompromised patients, especially those with diabetic ketoacidosis and neutropenia. Given that this patient had no relevant medical history and was otherwise healthy, he was at extremely low risk of this type of infection. In this patient’s case, the spores of this nonseptate hyphae wide-branching species were most likely introduced at the time of left Achilles tendon repair. Mucormycosis is progressive and can be fatal unless treated, with a mortality rate approaching 70%.5 The rarity and heterogeneity of mucormycosis make treatment variable.6 No prospective or randomized clinical trials exist in plastic surgery literature.
The use of wound VAC in combination with the instillation of amphotericin B to treat cutaneous mucormycosis is not well documented. Mucormycosis infections are traditionally addressed with surgical debridement and antifungal therapy, specifically IV amphotericin B.7,8 As previously noted, NPWT has become the gold standard in treating complex wounds.3 Additionally, wound VAC therapy with instillation has been noted in the literature as a reliable method to treat bacteria-infected wounds, providing a shorter treatment period and earlier wound closure.9 Instillation VAC therapy has proven particularly useful in complex, infected wounds, such as aggressive fungal infections.
Mucormycosis treatment is challenging particularly in the extremities as management must balance both mortality and limb salvage. In this case, the use of NPWT with wound VAC and intervals of instilling amphotericin B facilitated infection control in this lower extremity mucormycosis infection. The significant adverse effect profile of amphotericin B, particularly the nephrotoxicity, should be seriously considered when deciding the treatment regimen for patients affected by mucormycosis. Locally, topical amphotericin B has been reported to cause blistering, itchiness, redness, peeling, and dryness. However, topical preparations of amphotericin B are nontoxic unlike their IV counterpart, able to cross the physiological barriers of the skin while simultaneously targeting macrophages in the dermis and epidermis.10
Conclusions
Although the mainstay of treatment for systemic mucormycosis is radical debridement and IV amphotericin B, a more localized infection may benefit from an adjunct like an instillation wound VAC with topical amphotericin B, as presented in this case study. Swift treatment with wound VAC was beneficial in the overall recovery and tissue healing of this patient and may be beneficial in similar cases.
1. Normandin S, Safran T, Winocour S, et al. negative pressure wound therapy: mechanism of action and clinical applications. Semin Plast Surg. 2021;35(3):164-170. doi:10.1055/s-0041-1731792
2. Agarwal P, Kukrele R, Sharma D. Vacuum assisted closure (VAC)/negative pressure wound therapy (NPWT) for difficult wounds: a review. J Clin Orthop Trauma. 2019;10(5):845-848. doi:10.1016/j.jcot.2019.06.015
3. Gabriel A, Shores J, Bernstein B, et al. A clinical review of infected wound treatment with Vacuum Assisted Closure (V.A.C.) therapy: experience and case series. Int Wound J. 2009;6(suppl 2):1-25. doi:10.1111/j.1742-481X.2009.00628.x
4. Guégan S, Lanternier F, Rouzaud C, Dupin N, Lortholary O. Fungal skin and soft tissue infections. Curr Opin Infect Dis. 2016;29(2):124-130. doi:10.1097/QCO.0000000000000252
5. Ibrahim AS, Spellberg B, Walsh TJ, Kontoyiannis DP. Pathogenesis of mucormycosis. Clin Infect Dis. 2012;54(suppl 1):S16-S22. doi:10.1093/cid/cir865
6. Sipsas NV, Gamaletsou MN, Anastasopoulou A, Kontoyiannis DP. Therapy of mucormycosis. J Fungi (Basel). 2018;4(3):90. Published 2018 Jul 31. doi:10.3390/jof4030090
7. Spellberg B, Edwards J Jr, Ibrahim A. Novel perspectives on mucormycosis: pathophysiology, presentation, and management. Clin Microbiol Rev. 2005;18(3):556-569. doi:10.1128/CMR.18.3.556-569.2005
8. Losee JE, Selber J, Vega S, Hall C, Scott G, Serletti JM. Primary cutaneous mucormycosis: guide to surgical management. Ann Plast Surg. 2002;49(4):385-390. doi:10.1097/00000637-200210000-00009
9. Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002;10(5):303-311. doi:10.5435/00124635-200209000-00002
10. Varikuti S, Oghumu S, Saljoughian N, et al. Topical treatment with nanoliposomal Amphotericin B reduces early lesion growth but fails to induce cure in an experimental model of cutaneous leishmaniasis caused by Leishmania mexicana. Acta Trop. 2017;173:102-108. doi:10.1016/j.actatropica.2017.06.004
1. Normandin S, Safran T, Winocour S, et al. negative pressure wound therapy: mechanism of action and clinical applications. Semin Plast Surg. 2021;35(3):164-170. doi:10.1055/s-0041-1731792
2. Agarwal P, Kukrele R, Sharma D. Vacuum assisted closure (VAC)/negative pressure wound therapy (NPWT) for difficult wounds: a review. J Clin Orthop Trauma. 2019;10(5):845-848. doi:10.1016/j.jcot.2019.06.015
3. Gabriel A, Shores J, Bernstein B, et al. A clinical review of infected wound treatment with Vacuum Assisted Closure (V.A.C.) therapy: experience and case series. Int Wound J. 2009;6(suppl 2):1-25. doi:10.1111/j.1742-481X.2009.00628.x
4. Guégan S, Lanternier F, Rouzaud C, Dupin N, Lortholary O. Fungal skin and soft tissue infections. Curr Opin Infect Dis. 2016;29(2):124-130. doi:10.1097/QCO.0000000000000252
5. Ibrahim AS, Spellberg B, Walsh TJ, Kontoyiannis DP. Pathogenesis of mucormycosis. Clin Infect Dis. 2012;54(suppl 1):S16-S22. doi:10.1093/cid/cir865
6. Sipsas NV, Gamaletsou MN, Anastasopoulou A, Kontoyiannis DP. Therapy of mucormycosis. J Fungi (Basel). 2018;4(3):90. Published 2018 Jul 31. doi:10.3390/jof4030090
7. Spellberg B, Edwards J Jr, Ibrahim A. Novel perspectives on mucormycosis: pathophysiology, presentation, and management. Clin Microbiol Rev. 2005;18(3):556-569. doi:10.1128/CMR.18.3.556-569.2005
8. Losee JE, Selber J, Vega S, Hall C, Scott G, Serletti JM. Primary cutaneous mucormycosis: guide to surgical management. Ann Plast Surg. 2002;49(4):385-390. doi:10.1097/00000637-200210000-00009
9. Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002;10(5):303-311. doi:10.5435/00124635-200209000-00002
10. Varikuti S, Oghumu S, Saljoughian N, et al. Topical treatment with nanoliposomal Amphotericin B reduces early lesion growth but fails to induce cure in an experimental model of cutaneous leishmaniasis caused by Leishmania mexicana. Acta Trop. 2017;173:102-108. doi:10.1016/j.actatropica.2017.06.004
A technicality could keep RSV shots from kids in need
which has put an estimated 90,000 U.S. infants and small children in the hospital since the start of October.
But only one of the shots is designed to be given to babies, and a glitch in congressional language may make it difficult to allow children from low-income families to get it as readily as the well insured.
Since 1994, routine vaccination has been a childhood entitlement under the Vaccines for Children program, through which the federal government buys millions of vaccines and provides them free through pediatricians and clinics to children who are uninsured, underinsured, or on Medicaid – more than half of all American kids.
The 1993 law creating the program didn’t specifically include antibody shots, which were used only as rare emergency therapy at the time the bill was written.
But the first medication of its kind likely to be available to babies, called nirsevimab (it was approved in Europe in December, and Food and Drug Administration approval is expected in the summer of 2023), is not a vaccine but rather a monoclonal antibody that neutralizes RSV in the bloodstream.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is certain to recommend giving the antibody to infants, said Kelly Moore, MD, president of the advocacy group Immunize.org. The CDC is currently assessing whether nirsevimab would be eligible for the Vaccines for Children program, agency spokesperson Kristen Nordlund told KHN.
Failing to do so would “consign thousands upon thousands of infants to hospitalization and serious illness for semantic reasons despite existence of an immunization that functionally performs just like a seasonal vaccine,” Dr. Moore said.
Officials from Sanofi, which is producing the nirsevimab injection along with AstraZeneca, declined to state a price but said the range would be similar to that of a pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions annually if it’s given to a large share of the 3.7 million or so children born in the U.S. each year.
Pfizer and GlaxoSmithKline are making traditional vaccines against RSV and expect FDA approval later in 2023. Pfizer’s shot initially would be given to pregnant women – to shield their babies from the disease – while GSK’s would be given to the elderly.
Vaccines designed for infants are in the pipeline, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two toddlers, and immunologists aren’t totally in agreement over the cause, said Barney Graham, MD, PhD, the retired National Institutes of Health scientist whose studies of the episode contributed to successful COVID-19 and RSV vaccines.
After 2 years of COVID lockdowns and masking slowed its transmission, RSV exploded across the United States in 2023, swamping pediatric intensive care units.
Sanofi and AstraZeneca hope to have nirsevimab approved by the FDA, recommended by the CDC, and deployed nationwide by fall to prevent future RSV epidemics.
Their product is designed to be provided before a baby’s first winter RSV season. In clinical trials, the antibodies provided up to 5 months of protection. Most children wouldn’t need a second dose because the virus is not a mortal danger to healthy kids over a year old, said Jon Heinrichs, a senior member of Sanofi’s vaccines division.
If the antibody treatment is not accepted for the Vaccines for Children program, that will limit access to the shot for the uninsured and those on Medicaid, the majority of whom represent racial or ethnic minorities, Dr. Moore said. The drugmakers would have to negotiate with each state’s Medicaid program to get it on their formularies.
Excluding the shot from Vaccines for Children “would only worsen existing health disparities,” said Sean O’Leary, MD, a professor of pediatrics at the University of Colorado at Denver, Aurora, and chair of the infectious diseases committee of the American Academy of Pediatrics.
RSV affects babies of all social classes but tends to hit poor, crowded households hardest, said Dr. Graham. “Family history of asthma or allergy makes it worse,” he said, and premature babies are also at higher risk.
While 2%-3% of U.S. infants are hospitalized with RSV each year, only a few hundred don’t survive. But as many as 10,000 people 65 and older perish because of an infection every year, and a little-discussed legal change will make RSV and other vaccines more available to this group.
A section of the 2022 Inflation Reduction Act that went into effect Jan. 1 ends out-of-pocket payments for all vaccines by Medicare patients – including RSV vaccines, if they are licensed for this group.
Before, “if you hadn’t met your deductible, it could be very expensive,” said Leonard Friedland, MD, vice president for scientific affairs and public health in GSK’s vaccines division, which also makes shingles and combination tetanus-diphtheria-whooping cough boosters covered by the new law. “It’s a tremendously important advance.”
Of course, high levels of vaccine hesitancy are likely to blunt uptake of the shots regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies vaccination attitudes.
New types of shots, like the Sanofi-AstraZeneca antibodies, often alarm parents, and Pfizer’s shot for pregnant women is likely to push fear buttons as well, she said.
Public health officials “don’t seem very savvy about how to get ahead” of claims that vaccines undermine fertility or otherwise harm people, said Ms. Reich.
On the other hand, this winter’s RSV epidemic will be persuasive to many parents, said Heidi Larson, leader of the Vaccine Confidence Project and a professor of anthropology at the London School of Hygiene and Tropical Medicine.
“It’s a scary thing to have your kid hospitalized with RSV,” she said.
While unfortunate, “the high number of children who died or were admitted to the ICU in the past season with RSV – in some ways that’s helpful,” said Laura Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York.
Specialists in her field haven’t really started talking about how to communicate with women about the vaccine, said Dr. Riley, who chairs the immunization group at the American College of Obstetricians and Gynecologists.
“Everyone’s been waiting to see if it gets approved,” she said. “The education has to start soon, but it’s hard to roll out education before you roll out the shot.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
which has put an estimated 90,000 U.S. infants and small children in the hospital since the start of October.
But only one of the shots is designed to be given to babies, and a glitch in congressional language may make it difficult to allow children from low-income families to get it as readily as the well insured.
Since 1994, routine vaccination has been a childhood entitlement under the Vaccines for Children program, through which the federal government buys millions of vaccines and provides them free through pediatricians and clinics to children who are uninsured, underinsured, or on Medicaid – more than half of all American kids.
The 1993 law creating the program didn’t specifically include antibody shots, which were used only as rare emergency therapy at the time the bill was written.
But the first medication of its kind likely to be available to babies, called nirsevimab (it was approved in Europe in December, and Food and Drug Administration approval is expected in the summer of 2023), is not a vaccine but rather a monoclonal antibody that neutralizes RSV in the bloodstream.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is certain to recommend giving the antibody to infants, said Kelly Moore, MD, president of the advocacy group Immunize.org. The CDC is currently assessing whether nirsevimab would be eligible for the Vaccines for Children program, agency spokesperson Kristen Nordlund told KHN.
Failing to do so would “consign thousands upon thousands of infants to hospitalization and serious illness for semantic reasons despite existence of an immunization that functionally performs just like a seasonal vaccine,” Dr. Moore said.
Officials from Sanofi, which is producing the nirsevimab injection along with AstraZeneca, declined to state a price but said the range would be similar to that of a pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions annually if it’s given to a large share of the 3.7 million or so children born in the U.S. each year.
Pfizer and GlaxoSmithKline are making traditional vaccines against RSV and expect FDA approval later in 2023. Pfizer’s shot initially would be given to pregnant women – to shield their babies from the disease – while GSK’s would be given to the elderly.
Vaccines designed for infants are in the pipeline, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two toddlers, and immunologists aren’t totally in agreement over the cause, said Barney Graham, MD, PhD, the retired National Institutes of Health scientist whose studies of the episode contributed to successful COVID-19 and RSV vaccines.
After 2 years of COVID lockdowns and masking slowed its transmission, RSV exploded across the United States in 2023, swamping pediatric intensive care units.
Sanofi and AstraZeneca hope to have nirsevimab approved by the FDA, recommended by the CDC, and deployed nationwide by fall to prevent future RSV epidemics.
Their product is designed to be provided before a baby’s first winter RSV season. In clinical trials, the antibodies provided up to 5 months of protection. Most children wouldn’t need a second dose because the virus is not a mortal danger to healthy kids over a year old, said Jon Heinrichs, a senior member of Sanofi’s vaccines division.
If the antibody treatment is not accepted for the Vaccines for Children program, that will limit access to the shot for the uninsured and those on Medicaid, the majority of whom represent racial or ethnic minorities, Dr. Moore said. The drugmakers would have to negotiate with each state’s Medicaid program to get it on their formularies.
Excluding the shot from Vaccines for Children “would only worsen existing health disparities,” said Sean O’Leary, MD, a professor of pediatrics at the University of Colorado at Denver, Aurora, and chair of the infectious diseases committee of the American Academy of Pediatrics.
RSV affects babies of all social classes but tends to hit poor, crowded households hardest, said Dr. Graham. “Family history of asthma or allergy makes it worse,” he said, and premature babies are also at higher risk.
While 2%-3% of U.S. infants are hospitalized with RSV each year, only a few hundred don’t survive. But as many as 10,000 people 65 and older perish because of an infection every year, and a little-discussed legal change will make RSV and other vaccines more available to this group.
A section of the 2022 Inflation Reduction Act that went into effect Jan. 1 ends out-of-pocket payments for all vaccines by Medicare patients – including RSV vaccines, if they are licensed for this group.
Before, “if you hadn’t met your deductible, it could be very expensive,” said Leonard Friedland, MD, vice president for scientific affairs and public health in GSK’s vaccines division, which also makes shingles and combination tetanus-diphtheria-whooping cough boosters covered by the new law. “It’s a tremendously important advance.”
Of course, high levels of vaccine hesitancy are likely to blunt uptake of the shots regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies vaccination attitudes.
New types of shots, like the Sanofi-AstraZeneca antibodies, often alarm parents, and Pfizer’s shot for pregnant women is likely to push fear buttons as well, she said.
Public health officials “don’t seem very savvy about how to get ahead” of claims that vaccines undermine fertility or otherwise harm people, said Ms. Reich.
On the other hand, this winter’s RSV epidemic will be persuasive to many parents, said Heidi Larson, leader of the Vaccine Confidence Project and a professor of anthropology at the London School of Hygiene and Tropical Medicine.
“It’s a scary thing to have your kid hospitalized with RSV,” she said.
While unfortunate, “the high number of children who died or were admitted to the ICU in the past season with RSV – in some ways that’s helpful,” said Laura Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York.
Specialists in her field haven’t really started talking about how to communicate with women about the vaccine, said Dr. Riley, who chairs the immunization group at the American College of Obstetricians and Gynecologists.
“Everyone’s been waiting to see if it gets approved,” she said. “The education has to start soon, but it’s hard to roll out education before you roll out the shot.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
which has put an estimated 90,000 U.S. infants and small children in the hospital since the start of October.
But only one of the shots is designed to be given to babies, and a glitch in congressional language may make it difficult to allow children from low-income families to get it as readily as the well insured.
Since 1994, routine vaccination has been a childhood entitlement under the Vaccines for Children program, through which the federal government buys millions of vaccines and provides them free through pediatricians and clinics to children who are uninsured, underinsured, or on Medicaid – more than half of all American kids.
The 1993 law creating the program didn’t specifically include antibody shots, which were used only as rare emergency therapy at the time the bill was written.
But the first medication of its kind likely to be available to babies, called nirsevimab (it was approved in Europe in December, and Food and Drug Administration approval is expected in the summer of 2023), is not a vaccine but rather a monoclonal antibody that neutralizes RSV in the bloodstream.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is certain to recommend giving the antibody to infants, said Kelly Moore, MD, president of the advocacy group Immunize.org. The CDC is currently assessing whether nirsevimab would be eligible for the Vaccines for Children program, agency spokesperson Kristen Nordlund told KHN.
Failing to do so would “consign thousands upon thousands of infants to hospitalization and serious illness for semantic reasons despite existence of an immunization that functionally performs just like a seasonal vaccine,” Dr. Moore said.
Officials from Sanofi, which is producing the nirsevimab injection along with AstraZeneca, declined to state a price but said the range would be similar to that of a pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions annually if it’s given to a large share of the 3.7 million or so children born in the U.S. each year.
Pfizer and GlaxoSmithKline are making traditional vaccines against RSV and expect FDA approval later in 2023. Pfizer’s shot initially would be given to pregnant women – to shield their babies from the disease – while GSK’s would be given to the elderly.
Vaccines designed for infants are in the pipeline, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two toddlers, and immunologists aren’t totally in agreement over the cause, said Barney Graham, MD, PhD, the retired National Institutes of Health scientist whose studies of the episode contributed to successful COVID-19 and RSV vaccines.
After 2 years of COVID lockdowns and masking slowed its transmission, RSV exploded across the United States in 2023, swamping pediatric intensive care units.
Sanofi and AstraZeneca hope to have nirsevimab approved by the FDA, recommended by the CDC, and deployed nationwide by fall to prevent future RSV epidemics.
Their product is designed to be provided before a baby’s first winter RSV season. In clinical trials, the antibodies provided up to 5 months of protection. Most children wouldn’t need a second dose because the virus is not a mortal danger to healthy kids over a year old, said Jon Heinrichs, a senior member of Sanofi’s vaccines division.
If the antibody treatment is not accepted for the Vaccines for Children program, that will limit access to the shot for the uninsured and those on Medicaid, the majority of whom represent racial or ethnic minorities, Dr. Moore said. The drugmakers would have to negotiate with each state’s Medicaid program to get it on their formularies.
Excluding the shot from Vaccines for Children “would only worsen existing health disparities,” said Sean O’Leary, MD, a professor of pediatrics at the University of Colorado at Denver, Aurora, and chair of the infectious diseases committee of the American Academy of Pediatrics.
RSV affects babies of all social classes but tends to hit poor, crowded households hardest, said Dr. Graham. “Family history of asthma or allergy makes it worse,” he said, and premature babies are also at higher risk.
While 2%-3% of U.S. infants are hospitalized with RSV each year, only a few hundred don’t survive. But as many as 10,000 people 65 and older perish because of an infection every year, and a little-discussed legal change will make RSV and other vaccines more available to this group.
A section of the 2022 Inflation Reduction Act that went into effect Jan. 1 ends out-of-pocket payments for all vaccines by Medicare patients – including RSV vaccines, if they are licensed for this group.
Before, “if you hadn’t met your deductible, it could be very expensive,” said Leonard Friedland, MD, vice president for scientific affairs and public health in GSK’s vaccines division, which also makes shingles and combination tetanus-diphtheria-whooping cough boosters covered by the new law. “It’s a tremendously important advance.”
Of course, high levels of vaccine hesitancy are likely to blunt uptake of the shots regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies vaccination attitudes.
New types of shots, like the Sanofi-AstraZeneca antibodies, often alarm parents, and Pfizer’s shot for pregnant women is likely to push fear buttons as well, she said.
Public health officials “don’t seem very savvy about how to get ahead” of claims that vaccines undermine fertility or otherwise harm people, said Ms. Reich.
On the other hand, this winter’s RSV epidemic will be persuasive to many parents, said Heidi Larson, leader of the Vaccine Confidence Project and a professor of anthropology at the London School of Hygiene and Tropical Medicine.
“It’s a scary thing to have your kid hospitalized with RSV,” she said.
While unfortunate, “the high number of children who died or were admitted to the ICU in the past season with RSV – in some ways that’s helpful,” said Laura Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York.
Specialists in her field haven’t really started talking about how to communicate with women about the vaccine, said Dr. Riley, who chairs the immunization group at the American College of Obstetricians and Gynecologists.
“Everyone’s been waiting to see if it gets approved,” she said. “The education has to start soon, but it’s hard to roll out education before you roll out the shot.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A White male presented with a 1½-year history of a progressive hypoesthetic annular, hyperpigmented plaque on the upper arm
Paucibacillary tuberculoid leprosy is characterized by few anesthetic hypo- or hyperpigmented lesions and can be accompanied by palpable peripheral nerve enlargements.
Tuberculoid leprosy presents histologically with epithelioid histiocytes with lymphocytes and Langhans giant cells. Neurotropic granulomas are also characteristic of tuberculoid leprosy. Fite staining allows for the identification of the acid-fast bacilli of M. leprae, which in some cases are quite few in number. The standard mycobacterium stain, Ziehl-Neelsen, is a good option for M. tuberculosis, but because of the relative weak mycolic acid coat of M. leprae, the Fite stain is more appropriate for identifying M. leprae.
Clinically, other than the presence of fewer than five hypoesthetic lesions that are either hypopigmented or erythematous, tuberculoid leprosy often presents with additional peripheral nerve involvement that manifests as numbness and tingling in hands and feet.1 This patient denied any tingling, weakness, or numbness, outside of the anesthetic lesion on his posterior upper arm.
The patient, born in the United States, had a remote history of military travel to Iraq, Kuwait, and the Philippines, but had not traveled internationally within the last 15 years, apart from a cruise to the Bahamas. He denied any known contact with individuals with similar lesions. He denied a history of contact with armadillos, but acknowledged that they are native to where he resides in central Florida, and that he had seen them in his yard.
Histopathological examination revealed an unremarkable epidermis with a superficial and deep perivascular, periadnexal, and perineural lymphohistiocytic infiltrate. Fite stain revealed rare rod-shaped organisms (Figure 2). These findings are consistent with a diagnosis of paucibacillary, tuberculoid leprosy.
The patient’s travel history to highly endemic areas (Middle East), as well as possible environmental contact with armadillos – including contact with soil that the armadillos occupied – could explain plausible modes of transmission. Following consultation with our infectious disease department and the National Hansen’s Disease Program, our patient began a planned course of therapy with 18 months of minocycline, rifampin, and moxifloxacin.
Human-to-human transmission of HD has been well documented; however, zoonotic transmission – specifically via the nine-banded armadillo (Dasypus novemcinctus) – serves as another suggested means of transmission, especially in the Southeastern United States.2-6 Travel to highly-endemic areas increases the risk of contracting HD, which may take up to 20 years following contact with the bacteria to manifest clinically.
While central Florida was previously thought to be a nonendemic area of disease, the incidence of the disease in this region has increased in recent years.7 Human-to-human transmission, which remains a concern with immigration from highly-endemic regions, occurs via long-term contact with nasal droplets of an infected person.8,9
Many patients in regions with very few cases of leprosy deny travel to other endemic regions and contact with infected people. Thus, zoonotic transmission remains a legitimate concern in the Southeastern United States – accounting, at least in part, for many of the non–human-transmitted cases of leprosy.2,10 We encourage clinicians to maintain a high level of clinical suspicion for leprosy when evaluating patients presenting with hypoesthetic cutaneous lesions and to obtain a travel history and to ask about armadillo exposure.
This case and the photos were submitted by Ms. Smith, from the University of South Florida, Tampa; Dr. Hatch and Dr. Sarriera-Lazaro, from the department of dermatology and cutaneous surgery, University of South Florida; and Dr. Turner and Dr. Beachkofsky, from the department of pathology and laboratory medicine at the James A. Haley Veterans’ Hospital, Tampa. Dr. Bilu Martin edited this case. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Leprosy (Hansen’s Disease), in: “Goldman’s Cecil Medicine,” 24th ed. (Philadelphia: W.B. Saunders, 2012: pp. 1950-4.
2. Sharma R et al. Emerg Infect Dis. 2015 Dec;21(12):2127-34.
3. Lane JE et al. J Am Acad Dermatol. 2006 Oct;55(4):714-6.
4. Clark BM et al. Am J Trop Med Hyg. 2008 Jun;78(6):962-7.
5. Bruce S et al. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):223-8.
6. Loughry WJ et al. J Wildl Dis. 2009 Jan;45(1):144-52.
7. FDo H. Florida charts: Hansen’s Disease (Leprosy). Health FDo. 2019. https://www.flhealthcharts.gov/ChartsReports/rdPage.aspx?rdReport=NonVitalIndNoGrpCounts.DataViewer&cid=174.
8. Maymone MBC et al. J Am Acad Dermatol. 2020 Jul;83(1):1-14.
9. Scollard DM et al. Clin Microbiol Rev. 2006 Apr;19(2):338-81.
10. Domozych R et al. JAAD Case Rep. 2016 May 12;2(3):189-92.
Paucibacillary tuberculoid leprosy is characterized by few anesthetic hypo- or hyperpigmented lesions and can be accompanied by palpable peripheral nerve enlargements.
Tuberculoid leprosy presents histologically with epithelioid histiocytes with lymphocytes and Langhans giant cells. Neurotropic granulomas are also characteristic of tuberculoid leprosy. Fite staining allows for the identification of the acid-fast bacilli of M. leprae, which in some cases are quite few in number. The standard mycobacterium stain, Ziehl-Neelsen, is a good option for M. tuberculosis, but because of the relative weak mycolic acid coat of M. leprae, the Fite stain is more appropriate for identifying M. leprae.
Clinically, other than the presence of fewer than five hypoesthetic lesions that are either hypopigmented or erythematous, tuberculoid leprosy often presents with additional peripheral nerve involvement that manifests as numbness and tingling in hands and feet.1 This patient denied any tingling, weakness, or numbness, outside of the anesthetic lesion on his posterior upper arm.
The patient, born in the United States, had a remote history of military travel to Iraq, Kuwait, and the Philippines, but had not traveled internationally within the last 15 years, apart from a cruise to the Bahamas. He denied any known contact with individuals with similar lesions. He denied a history of contact with armadillos, but acknowledged that they are native to where he resides in central Florida, and that he had seen them in his yard.
Histopathological examination revealed an unremarkable epidermis with a superficial and deep perivascular, periadnexal, and perineural lymphohistiocytic infiltrate. Fite stain revealed rare rod-shaped organisms (Figure 2). These findings are consistent with a diagnosis of paucibacillary, tuberculoid leprosy.
The patient’s travel history to highly endemic areas (Middle East), as well as possible environmental contact with armadillos – including contact with soil that the armadillos occupied – could explain plausible modes of transmission. Following consultation with our infectious disease department and the National Hansen’s Disease Program, our patient began a planned course of therapy with 18 months of minocycline, rifampin, and moxifloxacin.
Human-to-human transmission of HD has been well documented; however, zoonotic transmission – specifically via the nine-banded armadillo (Dasypus novemcinctus) – serves as another suggested means of transmission, especially in the Southeastern United States.2-6 Travel to highly-endemic areas increases the risk of contracting HD, which may take up to 20 years following contact with the bacteria to manifest clinically.
While central Florida was previously thought to be a nonendemic area of disease, the incidence of the disease in this region has increased in recent years.7 Human-to-human transmission, which remains a concern with immigration from highly-endemic regions, occurs via long-term contact with nasal droplets of an infected person.8,9
Many patients in regions with very few cases of leprosy deny travel to other endemic regions and contact with infected people. Thus, zoonotic transmission remains a legitimate concern in the Southeastern United States – accounting, at least in part, for many of the non–human-transmitted cases of leprosy.2,10 We encourage clinicians to maintain a high level of clinical suspicion for leprosy when evaluating patients presenting with hypoesthetic cutaneous lesions and to obtain a travel history and to ask about armadillo exposure.
This case and the photos were submitted by Ms. Smith, from the University of South Florida, Tampa; Dr. Hatch and Dr. Sarriera-Lazaro, from the department of dermatology and cutaneous surgery, University of South Florida; and Dr. Turner and Dr. Beachkofsky, from the department of pathology and laboratory medicine at the James A. Haley Veterans’ Hospital, Tampa. Dr. Bilu Martin edited this case. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Leprosy (Hansen’s Disease), in: “Goldman’s Cecil Medicine,” 24th ed. (Philadelphia: W.B. Saunders, 2012: pp. 1950-4.
2. Sharma R et al. Emerg Infect Dis. 2015 Dec;21(12):2127-34.
3. Lane JE et al. J Am Acad Dermatol. 2006 Oct;55(4):714-6.
4. Clark BM et al. Am J Trop Med Hyg. 2008 Jun;78(6):962-7.
5. Bruce S et al. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):223-8.
6. Loughry WJ et al. J Wildl Dis. 2009 Jan;45(1):144-52.
7. FDo H. Florida charts: Hansen’s Disease (Leprosy). Health FDo. 2019. https://www.flhealthcharts.gov/ChartsReports/rdPage.aspx?rdReport=NonVitalIndNoGrpCounts.DataViewer&cid=174.
8. Maymone MBC et al. J Am Acad Dermatol. 2020 Jul;83(1):1-14.
9. Scollard DM et al. Clin Microbiol Rev. 2006 Apr;19(2):338-81.
10. Domozych R et al. JAAD Case Rep. 2016 May 12;2(3):189-92.
Paucibacillary tuberculoid leprosy is characterized by few anesthetic hypo- or hyperpigmented lesions and can be accompanied by palpable peripheral nerve enlargements.
Tuberculoid leprosy presents histologically with epithelioid histiocytes with lymphocytes and Langhans giant cells. Neurotropic granulomas are also characteristic of tuberculoid leprosy. Fite staining allows for the identification of the acid-fast bacilli of M. leprae, which in some cases are quite few in number. The standard mycobacterium stain, Ziehl-Neelsen, is a good option for M. tuberculosis, but because of the relative weak mycolic acid coat of M. leprae, the Fite stain is more appropriate for identifying M. leprae.
Clinically, other than the presence of fewer than five hypoesthetic lesions that are either hypopigmented or erythematous, tuberculoid leprosy often presents with additional peripheral nerve involvement that manifests as numbness and tingling in hands and feet.1 This patient denied any tingling, weakness, or numbness, outside of the anesthetic lesion on his posterior upper arm.
The patient, born in the United States, had a remote history of military travel to Iraq, Kuwait, and the Philippines, but had not traveled internationally within the last 15 years, apart from a cruise to the Bahamas. He denied any known contact with individuals with similar lesions. He denied a history of contact with armadillos, but acknowledged that they are native to where he resides in central Florida, and that he had seen them in his yard.
Histopathological examination revealed an unremarkable epidermis with a superficial and deep perivascular, periadnexal, and perineural lymphohistiocytic infiltrate. Fite stain revealed rare rod-shaped organisms (Figure 2). These findings are consistent with a diagnosis of paucibacillary, tuberculoid leprosy.
The patient’s travel history to highly endemic areas (Middle East), as well as possible environmental contact with armadillos – including contact with soil that the armadillos occupied – could explain plausible modes of transmission. Following consultation with our infectious disease department and the National Hansen’s Disease Program, our patient began a planned course of therapy with 18 months of minocycline, rifampin, and moxifloxacin.
Human-to-human transmission of HD has been well documented; however, zoonotic transmission – specifically via the nine-banded armadillo (Dasypus novemcinctus) – serves as another suggested means of transmission, especially in the Southeastern United States.2-6 Travel to highly-endemic areas increases the risk of contracting HD, which may take up to 20 years following contact with the bacteria to manifest clinically.
While central Florida was previously thought to be a nonendemic area of disease, the incidence of the disease in this region has increased in recent years.7 Human-to-human transmission, which remains a concern with immigration from highly-endemic regions, occurs via long-term contact with nasal droplets of an infected person.8,9
Many patients in regions with very few cases of leprosy deny travel to other endemic regions and contact with infected people. Thus, zoonotic transmission remains a legitimate concern in the Southeastern United States – accounting, at least in part, for many of the non–human-transmitted cases of leprosy.2,10 We encourage clinicians to maintain a high level of clinical suspicion for leprosy when evaluating patients presenting with hypoesthetic cutaneous lesions and to obtain a travel history and to ask about armadillo exposure.
This case and the photos were submitted by Ms. Smith, from the University of South Florida, Tampa; Dr. Hatch and Dr. Sarriera-Lazaro, from the department of dermatology and cutaneous surgery, University of South Florida; and Dr. Turner and Dr. Beachkofsky, from the department of pathology and laboratory medicine at the James A. Haley Veterans’ Hospital, Tampa. Dr. Bilu Martin edited this case. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Leprosy (Hansen’s Disease), in: “Goldman’s Cecil Medicine,” 24th ed. (Philadelphia: W.B. Saunders, 2012: pp. 1950-4.
2. Sharma R et al. Emerg Infect Dis. 2015 Dec;21(12):2127-34.
3. Lane JE et al. J Am Acad Dermatol. 2006 Oct;55(4):714-6.
4. Clark BM et al. Am J Trop Med Hyg. 2008 Jun;78(6):962-7.
5. Bruce S et al. J Am Acad Dermatol. 2000 Aug;43(2 Pt 1):223-8.
6. Loughry WJ et al. J Wildl Dis. 2009 Jan;45(1):144-52.
7. FDo H. Florida charts: Hansen’s Disease (Leprosy). Health FDo. 2019. https://www.flhealthcharts.gov/ChartsReports/rdPage.aspx?rdReport=NonVitalIndNoGrpCounts.DataViewer&cid=174.
8. Maymone MBC et al. J Am Acad Dermatol. 2020 Jul;83(1):1-14.
9. Scollard DM et al. Clin Microbiol Rev. 2006 Apr;19(2):338-81.
10. Domozych R et al. JAAD Case Rep. 2016 May 12;2(3):189-92.
A 44-year-old White male presented with a 1½-year history of a progressive hypoesthetic annular, mildly hyperpigmented plaque on the left posterior upper arm.
He denied pruritus, pain, or systemic symptoms including weight loss, visual changes, cough, dyspnea, and abdominal pain. He also denied any paresthesia or weakness. On physical examination, there is a subtle, solitary 4-cm annular skin-colored thin plaque on the patient's left posterior upper arm (Figure 1).
Punch biopsy of the lesion was performed, and the histopathological findings are illustrated in Figure 2.
Advice on antibiotics for kids during shortages
Pharmacies are running out of the antibiotics used to treat serious infections in children. This leaves parents and doctors frustrated and scared.
After weeks of overcrowded waiting rooms, extended office hours, and countless telephone calls during the viral respiratory surge, pediatricians are now facing a new challenge: an ever-growing list of medication shortages, including many of the most commonly used antibiotics.
These shortages primarily affect liquid formulations, so children – and the pediatricians’ offices and pharmacies serving them – are disproportionately impacted. Though there are multiple factors contributing, antibiotic overuse for viral infections during the surge has undoubtedly catalyzed the current crisis. It can be scary for parents to watch a child miserable with fever, which is why parents and pediatricians look for a quick fix in antibiotics, but unnecessary prescriptions that contribute to ongoing shortages should be avoided. We, as practicing pediatricians, think that this is a moment for reflection on when and why we use antibiotics during viral season. Though antibiotic overuse may have led us into this shortage, better antibiotic stewardship may just lead us out of it.
Since amoxicillin was approved for medical use in 1974, it has been one of the most commonly prescribed antibiotics in children. It is particularly well-suited for use in children because it treats common pediatric infections such as ear infections, strep throat, and pneumonia. These factors, along with its low cost and bubblegum flavor, make it no surprise that amoxicillin was consistently one of the top 25 medications prescribed in the United States between 2013 and 2019, with over 25 million prescriptions annually.
Amoxicillin remains the best first-line treatment option for the most common bacterial respiratory tract infections in children. With liquid formulations scarce, pediatricians, parents, and pharmacists are getting creative with crushed tablets or sprinkling capsules when possible.
However, without liquid amoxicillin readily available in our pediatric arsenal, we have recently had to turn to antibiotics with higher costs and more side effects. These broad-spectrum antibiotics target a more extensive range of bacteria and are rarely necessary for common pediatric infections. Further, their use risks increasing the already dire problem of antibiotic resistance, which causes more than 35,000 deaths in the United States each year. And perhaps most importantly, broader spectrum antibiotics aren’t better than amoxicillin for the treatment of respiratory tract infections; they are sometimes worse.
The urge to turn to antibiotics as a potential cure for childhood illnesses is an understandable one for parents and clinicians alike. A common refrain in pediatrician offices is, “Isn’t there anything we can give them?” as parents look for respite in a long viral season. As viruses continue to surge, it is helpful to remember that children will get 8 to 10 viral infections per year, with most of those occurring in the fall and winter. When parents report that their child is always sick, they aren’t far off.
Most of these infections will be cured by a child’s own immune system rather than our medications. For example, in children older than 2 years, studies have demonstrated that waiting about 2 days to start antibiotics after an ear infection is diagnosed is just as effective as starting the antibiotics right away. As tempting as it is to ask for antibiotics early, that prescription may only worsen the situation if it is a virus. Instead, pediatricians can offer parents support in treating their children at home with humidifiers, pain/fever relievers when appropriate, honey in children over 12 months, and hydration.
This drug shortage is a pivotal moment for parents and clinicians to reconsider how and when we use antibiotics during viral season. Though antibiotics may be one of the greatest inventions of the 20th century, it is how we use them now that will determine our health in the century to come.
Dr. Lockwood is Associate Professor, department of pediatrics, University of Pennsylvania, Philadelphia. Dr. Same is Assistant Professor, department of clinical pediatrics, at the University of Pennsylvania. Neither reported any conflicts of interest.
A version of this article first appeared on Medscape.com.
Pharmacies are running out of the antibiotics used to treat serious infections in children. This leaves parents and doctors frustrated and scared.
After weeks of overcrowded waiting rooms, extended office hours, and countless telephone calls during the viral respiratory surge, pediatricians are now facing a new challenge: an ever-growing list of medication shortages, including many of the most commonly used antibiotics.
These shortages primarily affect liquid formulations, so children – and the pediatricians’ offices and pharmacies serving them – are disproportionately impacted. Though there are multiple factors contributing, antibiotic overuse for viral infections during the surge has undoubtedly catalyzed the current crisis. It can be scary for parents to watch a child miserable with fever, which is why parents and pediatricians look for a quick fix in antibiotics, but unnecessary prescriptions that contribute to ongoing shortages should be avoided. We, as practicing pediatricians, think that this is a moment for reflection on when and why we use antibiotics during viral season. Though antibiotic overuse may have led us into this shortage, better antibiotic stewardship may just lead us out of it.
Since amoxicillin was approved for medical use in 1974, it has been one of the most commonly prescribed antibiotics in children. It is particularly well-suited for use in children because it treats common pediatric infections such as ear infections, strep throat, and pneumonia. These factors, along with its low cost and bubblegum flavor, make it no surprise that amoxicillin was consistently one of the top 25 medications prescribed in the United States between 2013 and 2019, with over 25 million prescriptions annually.
Amoxicillin remains the best first-line treatment option for the most common bacterial respiratory tract infections in children. With liquid formulations scarce, pediatricians, parents, and pharmacists are getting creative with crushed tablets or sprinkling capsules when possible.
However, without liquid amoxicillin readily available in our pediatric arsenal, we have recently had to turn to antibiotics with higher costs and more side effects. These broad-spectrum antibiotics target a more extensive range of bacteria and are rarely necessary for common pediatric infections. Further, their use risks increasing the already dire problem of antibiotic resistance, which causes more than 35,000 deaths in the United States each year. And perhaps most importantly, broader spectrum antibiotics aren’t better than amoxicillin for the treatment of respiratory tract infections; they are sometimes worse.
The urge to turn to antibiotics as a potential cure for childhood illnesses is an understandable one for parents and clinicians alike. A common refrain in pediatrician offices is, “Isn’t there anything we can give them?” as parents look for respite in a long viral season. As viruses continue to surge, it is helpful to remember that children will get 8 to 10 viral infections per year, with most of those occurring in the fall and winter. When parents report that their child is always sick, they aren’t far off.
Most of these infections will be cured by a child’s own immune system rather than our medications. For example, in children older than 2 years, studies have demonstrated that waiting about 2 days to start antibiotics after an ear infection is diagnosed is just as effective as starting the antibiotics right away. As tempting as it is to ask for antibiotics early, that prescription may only worsen the situation if it is a virus. Instead, pediatricians can offer parents support in treating their children at home with humidifiers, pain/fever relievers when appropriate, honey in children over 12 months, and hydration.
This drug shortage is a pivotal moment for parents and clinicians to reconsider how and when we use antibiotics during viral season. Though antibiotics may be one of the greatest inventions of the 20th century, it is how we use them now that will determine our health in the century to come.
Dr. Lockwood is Associate Professor, department of pediatrics, University of Pennsylvania, Philadelphia. Dr. Same is Assistant Professor, department of clinical pediatrics, at the University of Pennsylvania. Neither reported any conflicts of interest.
A version of this article first appeared on Medscape.com.
Pharmacies are running out of the antibiotics used to treat serious infections in children. This leaves parents and doctors frustrated and scared.
After weeks of overcrowded waiting rooms, extended office hours, and countless telephone calls during the viral respiratory surge, pediatricians are now facing a new challenge: an ever-growing list of medication shortages, including many of the most commonly used antibiotics.
These shortages primarily affect liquid formulations, so children – and the pediatricians’ offices and pharmacies serving them – are disproportionately impacted. Though there are multiple factors contributing, antibiotic overuse for viral infections during the surge has undoubtedly catalyzed the current crisis. It can be scary for parents to watch a child miserable with fever, which is why parents and pediatricians look for a quick fix in antibiotics, but unnecessary prescriptions that contribute to ongoing shortages should be avoided. We, as practicing pediatricians, think that this is a moment for reflection on when and why we use antibiotics during viral season. Though antibiotic overuse may have led us into this shortage, better antibiotic stewardship may just lead us out of it.
Since amoxicillin was approved for medical use in 1974, it has been one of the most commonly prescribed antibiotics in children. It is particularly well-suited for use in children because it treats common pediatric infections such as ear infections, strep throat, and pneumonia. These factors, along with its low cost and bubblegum flavor, make it no surprise that amoxicillin was consistently one of the top 25 medications prescribed in the United States between 2013 and 2019, with over 25 million prescriptions annually.
Amoxicillin remains the best first-line treatment option for the most common bacterial respiratory tract infections in children. With liquid formulations scarce, pediatricians, parents, and pharmacists are getting creative with crushed tablets or sprinkling capsules when possible.
However, without liquid amoxicillin readily available in our pediatric arsenal, we have recently had to turn to antibiotics with higher costs and more side effects. These broad-spectrum antibiotics target a more extensive range of bacteria and are rarely necessary for common pediatric infections. Further, their use risks increasing the already dire problem of antibiotic resistance, which causes more than 35,000 deaths in the United States each year. And perhaps most importantly, broader spectrum antibiotics aren’t better than amoxicillin for the treatment of respiratory tract infections; they are sometimes worse.
The urge to turn to antibiotics as a potential cure for childhood illnesses is an understandable one for parents and clinicians alike. A common refrain in pediatrician offices is, “Isn’t there anything we can give them?” as parents look for respite in a long viral season. As viruses continue to surge, it is helpful to remember that children will get 8 to 10 viral infections per year, with most of those occurring in the fall and winter. When parents report that their child is always sick, they aren’t far off.
Most of these infections will be cured by a child’s own immune system rather than our medications. For example, in children older than 2 years, studies have demonstrated that waiting about 2 days to start antibiotics after an ear infection is diagnosed is just as effective as starting the antibiotics right away. As tempting as it is to ask for antibiotics early, that prescription may only worsen the situation if it is a virus. Instead, pediatricians can offer parents support in treating their children at home with humidifiers, pain/fever relievers when appropriate, honey in children over 12 months, and hydration.
This drug shortage is a pivotal moment for parents and clinicians to reconsider how and when we use antibiotics during viral season. Though antibiotics may be one of the greatest inventions of the 20th century, it is how we use them now that will determine our health in the century to come.
Dr. Lockwood is Associate Professor, department of pediatrics, University of Pennsylvania, Philadelphia. Dr. Same is Assistant Professor, department of clinical pediatrics, at the University of Pennsylvania. Neither reported any conflicts of interest.
A version of this article first appeared on Medscape.com.