Vaccines

A few weeks ago, a patient asked whether he could get my opinion on something unrelated to his yellow fever vaccine visit: He asked what I thought about the human papillomavirus (HPV) vaccine. His daughter’s primary care physician (PCP) had recommended it, but he “heard that it wasn’t safe.” We had a brief discussion.

My pediatric training days have long since ended, but I was taught never to miss an opportunity to immunize. In this case, it was to help a parent decide to immunize. This type of encounter is not unusual because, as part of preparing persons for international travel, I review their routine immunizations. When documentation of a vaccine is absent, it is pointed out and often remedied after a brief discussion.

Unfortunately, with HPV, too often parents state “my primary care physician said” it was optional, it was not required, or it was never recommended. Some were told to wait until their child was older, and several have safety concerns as did the parent above. I sometimes hear, “it’s not necessary for my child”; this is usually a clue indicating that the issue is more likely about how HPV is transmitted than what HPV vaccine can prevent. Most have welcomed the opportunity to discuss the vaccine, hear about its benefits, and have their questions answered. All leave with HPV information and are directed to websites that provide accurate information. They are referred to their PCP – hopefully to be immunized.

Three vaccines – meningococcal conjugate vaccine (MCV), Tdap, and HPV vaccine – all are recommended for administration at 11-12 years of age. A booster of MCV is recommended at 16 years. However, let’s focus on HPV. In 2007, HPV administration was recommended by the Advisory Committee on Immunization Practices (ACIP) for girls; by 2011, the recommendation was extended to boys. It was a three-dose schedule expected to be completed by age 13 years. In December 2016, a two-dose schedule administered at least 6 months apart was recommended for teens who initiated immunization at less than 15 years. Three doses were still recommended for those initiating HPV after 15 years. This was the only time the number of doses to complete a vaccine series had been decreased based on postlicensure data. So how well are we protecting our patients from HPV-related cancers?
 

Vaccine coverage

The National Immunization Survey–Teen (NIS-Teen) monitors vaccine coverage annually amongst adolescents aged 13-17 years. Data are obtained from individuals from every state, as well as the District of Columbia, the U.S. Virgin Islands, and six major urban areas.

According to the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2018 Aug 24;67[33]:909-17), HPV vaccination continues to lag behind Tdap and MCV in 2018. Among all adolescents, coverage with one or more doses of HPV was 66%, with up-to-date HPV status in 49%. In contrast, 82% received a dose of MCV, and 89% received a dose of Tdap.

Coverage for receiving one or more doses of HPV among females was 69%, and up-to-date HPV status was 53%; among males, coverage with one or more doses was 63%, and up-to-date HPV status was 44%.

Up-to-date HPV coverage status differed geographically, ranging from 29% in Mississippi to 78% in DC. Overall, eight states and the District of Columbia reported increases in up-to-date status (District of Columbia, Louisiana, Massachusetts, Nebraska, North Carolina, South Carolina, Texas, Vermont, and Virginia). Kudos to Virginia for having the largest increase (20 percentage points).

Coverage also differed between urban and rural areas: one or more doses at 70% vs. 59% and up-to-date status at 52% vs. 42%.

HPV coverage differed by poverty level as well. It was higher for persons living below the poverty level, with one or more doses in 73% and up-to-date status in 54%, compared with persons living at or above poverty level at 63% and 47%, respectively.
 

HPV-related cancers

The most recent CDC data regarding types of HPV-associated cancers during 2011-2015 suggest that HPV types 16 and 18 account for the majority of cervical (78%) and oropharyngeal (86%) cancers.

Currently, there are more cases of oropharyngeal cancer than cervical, and we have no screening tool for the former.
 

Safety

Safety has been well documented. Since licensure, no serious safety concerns have been identified, contrary to what has been reported on various social and news media outlets. Yet it remains a concern for many parents who have delayed initiation of vaccine. Efficacy also has been documented in the United States and abroad.

Suggestions for improving HPV immunization coverage

Here are eight suggestions to help you recommend the vaccine and convince hesitant parents of its necessity:

1. Focus on your delivery of the HPV immunization recommendation. Clinician recommendation is the No. 1 reason parents vaccinate. The tone you use and how you make the recommendation can affect how the parent perceives the importance of this vaccine. The following are components of a high-quality recommendation (Academic Pediatrics. 2018;18:S23-S27):

• Routinely recommend vaccine at 11-12 years.
• Recommend vaccine for all preteens, not just those you feel are at risk for infection.
• Recommend the vaccine be given the same day it is discussed.
• Use language that expresses the importance of the HPV vaccine.

2. Use the “announcement or presumptive approach.” You expect the parent to agree with your recommendation. You don’t want to convey that it is an option.

3. Remind parents that immunizing on time means only two doses of HPV.

4. Revisit the topic again during another visit if a parent declines. Data suggest secondary acceptance can be as high as 66%.

5. Consider using a motivational interviewing approach for parents who are very hesitant to vaccinate. Most people want to comply with recommended health interventions.

6. Educate your staff about the importance of HPV vaccine and how it prevents cancer.

7. Determine how well your practice immunizes adolescents. This would be a perfect quality improvement project.

8. Explore “Answering Parents’ Questions” and other resources at www.cdc.gov/hpv to find quick answers to HPV vaccine–related questions .

Why is HPV coverage, a vaccine to prevent cancer, still lagging behind Tdap and MCV? I am as puzzled as others. What I do know is this: Our children will mature and one day become sexually active. They can be exposed to and get infected with HPV, and we can’t predict which ones will not clear the virus and end up developing an HPV-related cancer in the future. At the end of the day, HPV vaccination is cancer prevention.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

A few weeks ago, a patient asked whether he could get my opinion on something unrelated to his yellow fever vaccine visit: He asked what I thought about the human papillomavirus (HPV) vaccine. His daughter’s primary care physician (PCP) had recommended it, but he “heard that it wasn’t safe.” We had a brief discussion.

My pediatric training days have long since ended, but I was taught never to miss an opportunity to immunize. In this case, it was to help a parent decide to immunize. This type of encounter is not unusual because, as part of preparing persons for international travel, I review their routine immunizations. When documentation of a vaccine is absent, it is pointed out and often remedied after a brief discussion.

Unfortunately, with HPV, too often parents state “my primary care physician said” it was optional, it was not required, or it was never recommended. Some were told to wait until their child was older, and several have safety concerns as did the parent above. I sometimes hear, “it’s not necessary for my child”; this is usually a clue indicating that the issue is more likely about how HPV is transmitted than what HPV vaccine can prevent. Most have welcomed the opportunity to discuss the vaccine, hear about its benefits, and have their questions answered. All leave with HPV information and are directed to websites that provide accurate information. They are referred to their PCP – hopefully to be immunized.

Three vaccines – meningococcal conjugate vaccine (MCV), Tdap, and HPV vaccine – all are recommended for administration at 11-12 years of age. A booster of MCV is recommended at 16 years. However, let’s focus on HPV. In 2007, HPV administration was recommended by the Advisory Committee on Immunization Practices (ACIP) for girls; by 2011, the recommendation was extended to boys. It was a three-dose schedule expected to be completed by age 13 years. In December 2016, a two-dose schedule administered at least 6 months apart was recommended for teens who initiated immunization at less than 15 years. Three doses were still recommended for those initiating HPV after 15 years. This was the only time the number of doses to complete a vaccine series had been decreased based on postlicensure data. So how well are we protecting our patients from HPV-related cancers?
 

Vaccine coverage

The National Immunization Survey–Teen (NIS-Teen) monitors vaccine coverage annually amongst adolescents aged 13-17 years. Data are obtained from individuals from every state, as well as the District of Columbia, the U.S. Virgin Islands, and six major urban areas.

According to the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2018 Aug 24;67[33]:909-17), HPV vaccination continues to lag behind Tdap and MCV in 2018. Among all adolescents, coverage with one or more doses of HPV was 66%, with up-to-date HPV status in 49%. In contrast, 82% received a dose of MCV, and 89% received a dose of Tdap.

Coverage for receiving one or more doses of HPV among females was 69%, and up-to-date HPV status was 53%; among males, coverage with one or more doses was 63%, and up-to-date HPV status was 44%.

Up-to-date HPV coverage status differed geographically, ranging from 29% in Mississippi to 78% in DC. Overall, eight states and the District of Columbia reported increases in up-to-date status (District of Columbia, Louisiana, Massachusetts, Nebraska, North Carolina, South Carolina, Texas, Vermont, and Virginia). Kudos to Virginia for having the largest increase (20 percentage points).

Coverage also differed between urban and rural areas: one or more doses at 70% vs. 59% and up-to-date status at 52% vs. 42%.

HPV coverage differed by poverty level as well. It was higher for persons living below the poverty level, with one or more doses in 73% and up-to-date status in 54%, compared with persons living at or above poverty level at 63% and 47%, respectively.
 

HPV-related cancers

The most recent CDC data regarding types of HPV-associated cancers during 2011-2015 suggest that HPV types 16 and 18 account for the majority of cervical (78%) and oropharyngeal (86%) cancers.

Currently, there are more cases of oropharyngeal cancer than cervical, and we have no screening tool for the former.
 

Safety

Safety has been well documented. Since licensure, no serious safety concerns have been identified, contrary to what has been reported on various social and news media outlets. Yet it remains a concern for many parents who have delayed initiation of vaccine. Efficacy also has been documented in the United States and abroad.

Suggestions for improving HPV immunization coverage

Here are eight suggestions to help you recommend the vaccine and convince hesitant parents of its necessity:

1. Focus on your delivery of the HPV immunization recommendation. Clinician recommendation is the No. 1 reason parents vaccinate. The tone you use and how you make the recommendation can affect how the parent perceives the importance of this vaccine. The following are components of a high-quality recommendation (Academic Pediatrics. 2018;18:S23-S27):

• Routinely recommend vaccine at 11-12 years.
• Recommend vaccine for all preteens, not just those you feel are at risk for infection.
• Recommend the vaccine be given the same day it is discussed.
• Use language that expresses the importance of the HPV vaccine.

2. Use the “announcement or presumptive approach.” You expect the parent to agree with your recommendation. You don’t want to convey that it is an option.

3. Remind parents that immunizing on time means only two doses of HPV.

4. Revisit the topic again during another visit if a parent declines. Data suggest secondary acceptance can be as high as 66%.

5. Consider using a motivational interviewing approach for parents who are very hesitant to vaccinate. Most people want to comply with recommended health interventions.

6. Educate your staff about the importance of HPV vaccine and how it prevents cancer.

7. Determine how well your practice immunizes adolescents. This would be a perfect quality improvement project.

8. Explore “Answering Parents’ Questions” and other resources at www.cdc.gov/hpv to find quick answers to HPV vaccine–related questions .

Why is HPV coverage, a vaccine to prevent cancer, still lagging behind Tdap and MCV? I am as puzzled as others. What I do know is this: Our children will mature and one day become sexually active. They can be exposed to and get infected with HPV, and we can’t predict which ones will not clear the virus and end up developing an HPV-related cancer in the future. At the end of the day, HPV vaccination is cancer prevention.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

A few weeks ago, a patient asked whether he could get my opinion on something unrelated to his yellow fever vaccine visit: He asked what I thought about the human papillomavirus (HPV) vaccine. His daughter’s primary care physician (PCP) had recommended it, but he “heard that it wasn’t safe.” We had a brief discussion.

My pediatric training days have long since ended, but I was taught never to miss an opportunity to immunize. In this case, it was to help a parent decide to immunize. This type of encounter is not unusual because, as part of preparing persons for international travel, I review their routine immunizations. When documentation of a vaccine is absent, it is pointed out and often remedied after a brief discussion.

Unfortunately, with HPV, too often parents state “my primary care physician said” it was optional, it was not required, or it was never recommended. Some were told to wait until their child was older, and several have safety concerns as did the parent above. I sometimes hear, “it’s not necessary for my child”; this is usually a clue indicating that the issue is more likely about how HPV is transmitted than what HPV vaccine can prevent. Most have welcomed the opportunity to discuss the vaccine, hear about its benefits, and have their questions answered. All leave with HPV information and are directed to websites that provide accurate information. They are referred to their PCP – hopefully to be immunized.

Three vaccines – meningococcal conjugate vaccine (MCV), Tdap, and HPV vaccine – all are recommended for administration at 11-12 years of age. A booster of MCV is recommended at 16 years. However, let’s focus on HPV. In 2007, HPV administration was recommended by the Advisory Committee on Immunization Practices (ACIP) for girls; by 2011, the recommendation was extended to boys. It was a three-dose schedule expected to be completed by age 13 years. In December 2016, a two-dose schedule administered at least 6 months apart was recommended for teens who initiated immunization at less than 15 years. Three doses were still recommended for those initiating HPV after 15 years. This was the only time the number of doses to complete a vaccine series had been decreased based on postlicensure data. So how well are we protecting our patients from HPV-related cancers?
 

Vaccine coverage

The National Immunization Survey–Teen (NIS-Teen) monitors vaccine coverage annually amongst adolescents aged 13-17 years. Data are obtained from individuals from every state, as well as the District of Columbia, the U.S. Virgin Islands, and six major urban areas.

According to the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (2018 Aug 24;67[33]:909-17), HPV vaccination continues to lag behind Tdap and MCV in 2018. Among all adolescents, coverage with one or more doses of HPV was 66%, with up-to-date HPV status in 49%. In contrast, 82% received a dose of MCV, and 89% received a dose of Tdap.

Coverage for receiving one or more doses of HPV among females was 69%, and up-to-date HPV status was 53%; among males, coverage with one or more doses was 63%, and up-to-date HPV status was 44%.

Up-to-date HPV coverage status differed geographically, ranging from 29% in Mississippi to 78% in DC. Overall, eight states and the District of Columbia reported increases in up-to-date status (District of Columbia, Louisiana, Massachusetts, Nebraska, North Carolina, South Carolina, Texas, Vermont, and Virginia). Kudos to Virginia for having the largest increase (20 percentage points).

Coverage also differed between urban and rural areas: one or more doses at 70% vs. 59% and up-to-date status at 52% vs. 42%.

HPV coverage differed by poverty level as well. It was higher for persons living below the poverty level, with one or more doses in 73% and up-to-date status in 54%, compared with persons living at or above poverty level at 63% and 47%, respectively.
 

HPV-related cancers

The most recent CDC data regarding types of HPV-associated cancers during 2011-2015 suggest that HPV types 16 and 18 account for the majority of cervical (78%) and oropharyngeal (86%) cancers.

Currently, there are more cases of oropharyngeal cancer than cervical, and we have no screening tool for the former.
 

Safety

Safety has been well documented. Since licensure, no serious safety concerns have been identified, contrary to what has been reported on various social and news media outlets. Yet it remains a concern for many parents who have delayed initiation of vaccine. Efficacy also has been documented in the United States and abroad.

Suggestions for improving HPV immunization coverage

Here are eight suggestions to help you recommend the vaccine and convince hesitant parents of its necessity:

1. Focus on your delivery of the HPV immunization recommendation. Clinician recommendation is the No. 1 reason parents vaccinate. The tone you use and how you make the recommendation can affect how the parent perceives the importance of this vaccine. The following are components of a high-quality recommendation (Academic Pediatrics. 2018;18:S23-S27):

• Routinely recommend vaccine at 11-12 years.
• Recommend vaccine for all preteens, not just those you feel are at risk for infection.
• Recommend the vaccine be given the same day it is discussed.
• Use language that expresses the importance of the HPV vaccine.

2. Use the “announcement or presumptive approach.” You expect the parent to agree with your recommendation. You don’t want to convey that it is an option.

3. Remind parents that immunizing on time means only two doses of HPV.

4. Revisit the topic again during another visit if a parent declines. Data suggest secondary acceptance can be as high as 66%.

5. Consider using a motivational interviewing approach for parents who are very hesitant to vaccinate. Most people want to comply with recommended health interventions.

6. Educate your staff about the importance of HPV vaccine and how it prevents cancer.

7. Determine how well your practice immunizes adolescents. This would be a perfect quality improvement project.

8. Explore “Answering Parents’ Questions” and other resources at www.cdc.gov/hpv to find quick answers to HPV vaccine–related questions .

Why is HPV coverage, a vaccine to prevent cancer, still lagging behind Tdap and MCV? I am as puzzled as others. What I do know is this: Our children will mature and one day become sexually active. They can be exposed to and get infected with HPV, and we can’t predict which ones will not clear the virus and end up developing an HPV-related cancer in the future. At the end of the day, HPV vaccination is cancer prevention.

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

Nearly all newborns who received an acellular pertussis-only vaccine at birth showed titers for pertussis and no difference in adverse events, compared with a group receiving only the hepatitis B vaccine, a randomized clinical trial from Australia has found.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

“These results indicate that a birth dose of aP vaccine is immunogenic in newborns and significantly narrows the immunity gap between birth and 14 days after receipt of DTaP at 6 or 8 weeks of age, marking the critical period when infants are most vulnerable to severe pertussis infection,” reported Nicholas Wood, PhD, of the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases in New South Wales, Australia, and his colleagues.

“Administration of the acellular pertussis vaccine at birth has the potential to reduce severe morbidity from Bordetella pertussis infection in the first 3 months of life, especially for infants of mothers who have not received a pertussis vaccine during pregnancy,” the researchers concluded in JAMA Pediatrics.

The researchers enrolled 417 infants from Sydney, Melbourne, Adelaide, and Perth between June 2010 and March 2013 and randomized them to receive either the hepatitis B vaccine alone (n = 205) or the hepatitis B vaccine with a monovalent acellular pertussis vaccine (n = 212) within the first 5 days after birth. The randomization was stratified for mothers’ receipt of the Tdap before pregnancy.

The Centers for Disease Control and Prevention currently recommends all newborns receive the hepatitis B vaccine shortly after birth and that pregnant women receive the Tdap vaccine during each pregnancy. There is not currently a monovalent acellular pertussis vaccine licensed in the United States.

The study infants then received the hexavalent DTaP-Hib-hep B-polio vaccine and the 10-valent pneumococcal conjugate vaccine at 6 weeks, 4 months, and 6 months.

The primary outcome was detectable levels of IgG antibody to pertussis toxin and pertactin at 10 weeks old.

Of the 206 infants receiving the pertussis vaccine at birth, 93% had detectable antibodies to pertussis toxin and pertactin at 10 weeks, compared with 51% of the 193 infants who received only the hepatitis B shot (P less than .001). Geometric mean concentration for pertussis toxin IgG also was four times higher in infants who received the pertussis vaccine at birth.

Adverse events were similar in the two groups both at birth and at 32 weeks, demonstrating that the pertussis birth dose is safe and tolerable.

“More important, in this study, the prevalence of fever after receipt of the birth dose, which can mistakenly be associated with potential sepsis and result in additional investigations in the neonatal period, was similar in both the group that received the aP vaccine at birth and the control group,” the authors reported.

A remaining question is the potential impact of maternal antibodies on protection from pertussis.

“The presence of maternal pertussis antibodies at birth can negatively affect postprimary responses to pertussis, diphtheria, and diphtheria-related CRM197 conjugate vaccines with a variety of infant immunization schedules and vaccines,” the authors noted. “The clinical significance of reductions in pertussis antibody related to maternal interference will require ongoing clinical evaluation, because there are no accepted serologic correlates of protection.”

The research was funded by a Australian National Health and Medical Research Council (NHMRC) grant, and several authors received NHMRC grants. One author also was supported by a Murdoch Children’s Research Institute Career Development Award. GlaxoSmithKline provided the vaccine and conducted the serologic assays. The authors reported having no conflicts of interest.

SOURCE: Wood N et al, JAMA Pediatr. 2018 Sep 10. doi: 10.1001/jamapediatrics.2018.2349.

Nearly all newborns who received an acellular pertussis-only vaccine at birth showed titers for pertussis and no difference in adverse events, compared with a group receiving only the hepatitis B vaccine, a randomized clinical trial from Australia has found.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

“These results indicate that a birth dose of aP vaccine is immunogenic in newborns and significantly narrows the immunity gap between birth and 14 days after receipt of DTaP at 6 or 8 weeks of age, marking the critical period when infants are most vulnerable to severe pertussis infection,” reported Nicholas Wood, PhD, of the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases in New South Wales, Australia, and his colleagues.

“Administration of the acellular pertussis vaccine at birth has the potential to reduce severe morbidity from Bordetella pertussis infection in the first 3 months of life, especially for infants of mothers who have not received a pertussis vaccine during pregnancy,” the researchers concluded in JAMA Pediatrics.

The researchers enrolled 417 infants from Sydney, Melbourne, Adelaide, and Perth between June 2010 and March 2013 and randomized them to receive either the hepatitis B vaccine alone (n = 205) or the hepatitis B vaccine with a monovalent acellular pertussis vaccine (n = 212) within the first 5 days after birth. The randomization was stratified for mothers’ receipt of the Tdap before pregnancy.

The Centers for Disease Control and Prevention currently recommends all newborns receive the hepatitis B vaccine shortly after birth and that pregnant women receive the Tdap vaccine during each pregnancy. There is not currently a monovalent acellular pertussis vaccine licensed in the United States.

The study infants then received the hexavalent DTaP-Hib-hep B-polio vaccine and the 10-valent pneumococcal conjugate vaccine at 6 weeks, 4 months, and 6 months.

The primary outcome was detectable levels of IgG antibody to pertussis toxin and pertactin at 10 weeks old.

Of the 206 infants receiving the pertussis vaccine at birth, 93% had detectable antibodies to pertussis toxin and pertactin at 10 weeks, compared with 51% of the 193 infants who received only the hepatitis B shot (P less than .001). Geometric mean concentration for pertussis toxin IgG also was four times higher in infants who received the pertussis vaccine at birth.

Adverse events were similar in the two groups both at birth and at 32 weeks, demonstrating that the pertussis birth dose is safe and tolerable.

“More important, in this study, the prevalence of fever after receipt of the birth dose, which can mistakenly be associated with potential sepsis and result in additional investigations in the neonatal period, was similar in both the group that received the aP vaccine at birth and the control group,” the authors reported.

A remaining question is the potential impact of maternal antibodies on protection from pertussis.

“The presence of maternal pertussis antibodies at birth can negatively affect postprimary responses to pertussis, diphtheria, and diphtheria-related CRM197 conjugate vaccines with a variety of infant immunization schedules and vaccines,” the authors noted. “The clinical significance of reductions in pertussis antibody related to maternal interference will require ongoing clinical evaluation, because there are no accepted serologic correlates of protection.”

The research was funded by a Australian National Health and Medical Research Council (NHMRC) grant, and several authors received NHMRC grants. One author also was supported by a Murdoch Children’s Research Institute Career Development Award. GlaxoSmithKline provided the vaccine and conducted the serologic assays. The authors reported having no conflicts of interest.

SOURCE: Wood N et al, JAMA Pediatr. 2018 Sep 10. doi: 10.1001/jamapediatrics.2018.2349.

Nearly all newborns who received an acellular pertussis-only vaccine at birth showed titers for pertussis and no difference in adverse events, compared with a group receiving only the hepatitis B vaccine, a randomized clinical trial from Australia has found.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

“These results indicate that a birth dose of aP vaccine is immunogenic in newborns and significantly narrows the immunity gap between birth and 14 days after receipt of DTaP at 6 or 8 weeks of age, marking the critical period when infants are most vulnerable to severe pertussis infection,” reported Nicholas Wood, PhD, of the National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases in New South Wales, Australia, and his colleagues.

“Administration of the acellular pertussis vaccine at birth has the potential to reduce severe morbidity from Bordetella pertussis infection in the first 3 months of life, especially for infants of mothers who have not received a pertussis vaccine during pregnancy,” the researchers concluded in JAMA Pediatrics.

The researchers enrolled 417 infants from Sydney, Melbourne, Adelaide, and Perth between June 2010 and March 2013 and randomized them to receive either the hepatitis B vaccine alone (n = 205) or the hepatitis B vaccine with a monovalent acellular pertussis vaccine (n = 212) within the first 5 days after birth. The randomization was stratified for mothers’ receipt of the Tdap before pregnancy.

The Centers for Disease Control and Prevention currently recommends all newborns receive the hepatitis B vaccine shortly after birth and that pregnant women receive the Tdap vaccine during each pregnancy. There is not currently a monovalent acellular pertussis vaccine licensed in the United States.

The study infants then received the hexavalent DTaP-Hib-hep B-polio vaccine and the 10-valent pneumococcal conjugate vaccine at 6 weeks, 4 months, and 6 months.

The primary outcome was detectable levels of IgG antibody to pertussis toxin and pertactin at 10 weeks old.

Of the 206 infants receiving the pertussis vaccine at birth, 93% had detectable antibodies to pertussis toxin and pertactin at 10 weeks, compared with 51% of the 193 infants who received only the hepatitis B shot (P less than .001). Geometric mean concentration for pertussis toxin IgG also was four times higher in infants who received the pertussis vaccine at birth.

Adverse events were similar in the two groups both at birth and at 32 weeks, demonstrating that the pertussis birth dose is safe and tolerable.

“More important, in this study, the prevalence of fever after receipt of the birth dose, which can mistakenly be associated with potential sepsis and result in additional investigations in the neonatal period, was similar in both the group that received the aP vaccine at birth and the control group,” the authors reported.

A remaining question is the potential impact of maternal antibodies on protection from pertussis.

“The presence of maternal pertussis antibodies at birth can negatively affect postprimary responses to pertussis, diphtheria, and diphtheria-related CRM197 conjugate vaccines with a variety of infant immunization schedules and vaccines,” the authors noted. “The clinical significance of reductions in pertussis antibody related to maternal interference will require ongoing clinical evaluation, because there are no accepted serologic correlates of protection.”

The research was funded by a Australian National Health and Medical Research Council (NHMRC) grant, and several authors received NHMRC grants. One author also was supported by a Murdoch Children’s Research Institute Career Development Award. GlaxoSmithKline provided the vaccine and conducted the serologic assays. The authors reported having no conflicts of interest.

SOURCE: Wood N et al, JAMA Pediatr. 2018 Sep 10. doi: 10.1001/jamapediatrics.2018.2349.

The 2017-2018 influenza season was one of the most severe in this century, according to every indicator measured by the Centers for Disease Control and Prevention (CDC). The proportion of outpatient visits due to influenza-like illness (ILI) was elevated nationally above a baseline of 2.2% for 19 straight weeks, and for 3 weeks it was over 7%.¹ High ILI activity was widespread and included all 50 states in January.

From October 2017 through April 2018, the CDC estimates that the influenza-related hospitalization rate was 106.6 per 100,000 population, with the highest rates among children 0 to 4 years (74.3/100,000), adults 50 to 64 years (115.7/100,000), and adults 65 years and older (460.9/100,000). More than 90% of adults hospitalized had a chronic condition, such as heart or lung disease, diabetes, or obesity, placing them at high risk for influenza complications.¹

Influenza severity is also measured as the proportion of deaths due to pneumonia and influenza, which was above the epidemic threshold for 16 weeks in 2017-2018 and was above 10% for 4 weeks in January.¹ Based on all of these indicators, the 2017-2018 influenza season was classified as high severity overall and for all age groups, the first time this has happened since the 2003-2004 season. There were 171 pediatric deaths attributed to influenza, and more than three-quarters of vaccine-eligible children who died from influenza this season had not received influenza vaccine.¹

The type of influenza predominating last season was influenza A from early- through mid-season, and was influenza B later in the season (see https://stacks.cdc.gov/view/cdc/54974).¹ For the entire season, 71.2% of specimens that tested positive for influenza in public health labs were Influenza A and 84.9% of these were H3N2.¹

Effectiveness of influenza vaccine last season. As measured by preventing respiratory illness needing medical attention, vaccine effectiveness was 36% overall: 25% against influenza A (H3N2), 67% against influenza A (H1N1), and 42% against influenza B.¹ Effectiveness varied by age, being the highest in those 8 years and younger.² Effectiveness was questionable in those older than 65, with an estimated effectiveness of 23% but confidence intervals including 0.²

While the effectiveness of influenza vaccines remains suboptimal, the morbidity and mortality they prevent is still considerable. The CDC estimates that in 2016-2017, more than 5 million influenza illnesses, 2.6 million medical visits, and 84,700 hospitalizations were prevented.³ And effectiveness last season was similar to, or better than, what has been seen in each of the past 10 years (FIGURE).⁴

Three drugs were recommended for use to treat influenza in 2017-1018 (oseltamivir, peramivir, and zanamivir), and no resistance was found except in 1% of influenza A (H1N1) tested.¹ No resistance was found in other A or any B viruses tested.¹

Continue to: Safety

The safety of influenza vaccines is studied each year by both the CDC and US Food and Drug Administration (FDA). This past year, studies were conducted using the CDC-supported Safety Datalink System, looking for increased rates of acute disseminated encephalomyelitis, anaphylaxis, Bell’s palsy, encephalitis, Guillain-Barré syndrome (GBS), seizures, and transverse myelitis.⁵ No safety signals were detected. However, for some of the newer vaccines, the numbers of vaccinated individuals studied were small. The FDA studied the incidence of GBS using Medicare data and found no increased rates in those vaccinated.⁵

2018-2019 Recommendations

There are only a few changes to the recommendations for the upcoming influenza season. The Advisory Committee on Immunization Practices (ACIP) still recommends universal vaccination for anyone age 6 months and older who does not have a contraindication (TABLE 1⁶). Two of the antigens in the vaccines for this coming season are slightly different from last season (TABLE 2⁷).

After 2 years of recommending against the use of live attenuated influenza vaccine (LAIV) because of its low effectiveness in children against influenza A (H1N1), ACIP now includes it as an option for the upcoming season in individuals ages 2 through 49 years.⁸ The basis of this revised recommendation was 2-fold: 1) evidence of LAIV effectiveness comparable to that of inactivated products against A (H3N2) and B viruses; and 2) evidence that a new strain of A (H1N1) now used to produce the vaccine (A/Slovenia) produces a significantly higher antibody response than the strain (A/Bolivia) used in the years when the vaccine was not effective against A (H1N1).

However, the new formulation’s clinical effectiveness against A (H1N1) has not been demonstrated, leading the American Academy of Pediatrics to recommend that LAIV should be used in children only if other options are not available or if injectable vaccine is refused.⁹ Contraindications to the use of LAIV remain the same as the previous version of the vaccine (TABLE 1⁶).

Individuals with non-severe egg allergies can receive any licensed, recommended age-appropriate influenza vaccine and no longer have to be monitored for 30 minutes after receiving the vaccine. People who have severe egg allergies should be vaccinated with an egg-free product or in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions.

Continue to: Children 6 months through 8 years...

Children 6 months through 8 years who have previously received an influenza vaccine, either trivalent or quadrivalent, need only 1 dose; those who have not received vaccination need 2 doses separated by at least 4 weeks.

Available vaccine products

A table found on the CDC influenza Web site lists the vaccine products available in the United States and the ages for which they are approved.⁶ The options now include 2 standard-dose trivalent inactivated influenza vaccines (IIV3), 4 standard-dose quadrivalent inactivated influenza vaccines (IIV4), one cell culture-based IIV4 (ccIIV4), one standard dose IIV4 intradermal option, a trivalent and a quadrivalent recombinant influenza vaccine (RIV3, RIV4), one LAIV, and 2 products for those 65 years and older—an adjuvanted IIV3 (aIIV3) and a high dose IIV3. Three of these products do not depend on egg-based technology: RIV3, RIV4, and ccIIV4.

Comparative effectiveness studies of these vaccine options, including those available for the elderly, are being conducted. Studies presented at the June 2018 ACIP meeting show comparable effectiveness of egg-based and non–egg-based products.⁶ At this time, ACIP does not make a preferential recommendation for any influenza vaccine product for any age group.

The 2017-2018 influenza season was one of the most severe in this century, according to every indicator measured by the Centers for Disease Control and Prevention (CDC). The proportion of outpatient visits due to influenza-like illness (ILI) was elevated nationally above a baseline of 2.2% for 19 straight weeks, and for 3 weeks it was over 7%.¹ High ILI activity was widespread and included all 50 states in January.

From October 2017 through April 2018, the CDC estimates that the influenza-related hospitalization rate was 106.6 per 100,000 population, with the highest rates among children 0 to 4 years (74.3/100,000), adults 50 to 64 years (115.7/100,000), and adults 65 years and older (460.9/100,000). More than 90% of adults hospitalized had a chronic condition, such as heart or lung disease, diabetes, or obesity, placing them at high risk for influenza complications.¹

Influenza severity is also measured as the proportion of deaths due to pneumonia and influenza, which was above the epidemic threshold for 16 weeks in 2017-2018 and was above 10% for 4 weeks in January.¹ Based on all of these indicators, the 2017-2018 influenza season was classified as high severity overall and for all age groups, the first time this has happened since the 2003-2004 season. There were 171 pediatric deaths attributed to influenza, and more than three-quarters of vaccine-eligible children who died from influenza this season had not received influenza vaccine.¹

The type of influenza predominating last season was influenza A from early- through mid-season, and was influenza B later in the season (see https://stacks.cdc.gov/view/cdc/54974).¹ For the entire season, 71.2% of specimens that tested positive for influenza in public health labs were Influenza A and 84.9% of these were H3N2.¹

Effectiveness of influenza vaccine last season. As measured by preventing respiratory illness needing medical attention, vaccine effectiveness was 36% overall: 25% against influenza A (H3N2), 67% against influenza A (H1N1), and 42% against influenza B.¹ Effectiveness varied by age, being the highest in those 8 years and younger.² Effectiveness was questionable in those older than 65, with an estimated effectiveness of 23% but confidence intervals including 0.²

While the effectiveness of influenza vaccines remains suboptimal, the morbidity and mortality they prevent is still considerable. The CDC estimates that in 2016-2017, more than 5 million influenza illnesses, 2.6 million medical visits, and 84,700 hospitalizations were prevented.³ And effectiveness last season was similar to, or better than, what has been seen in each of the past 10 years (FIGURE).⁴

Three drugs were recommended for use to treat influenza in 2017-1018 (oseltamivir, peramivir, and zanamivir), and no resistance was found except in 1% of influenza A (H1N1) tested.¹ No resistance was found in other A or any B viruses tested.¹

Continue to: Safety

The safety of influenza vaccines is studied each year by both the CDC and US Food and Drug Administration (FDA). This past year, studies were conducted using the CDC-supported Safety Datalink System, looking for increased rates of acute disseminated encephalomyelitis, anaphylaxis, Bell’s palsy, encephalitis, Guillain-Barré syndrome (GBS), seizures, and transverse myelitis.⁵ No safety signals were detected. However, for some of the newer vaccines, the numbers of vaccinated individuals studied were small. The FDA studied the incidence of GBS using Medicare data and found no increased rates in those vaccinated.⁵

2018-2019 Recommendations

There are only a few changes to the recommendations for the upcoming influenza season. The Advisory Committee on Immunization Practices (ACIP) still recommends universal vaccination for anyone age 6 months and older who does not have a contraindication (TABLE 1⁶). Two of the antigens in the vaccines for this coming season are slightly different from last season (TABLE 2⁷).

After 2 years of recommending against the use of live attenuated influenza vaccine (LAIV) because of its low effectiveness in children against influenza A (H1N1), ACIP now includes it as an option for the upcoming season in individuals ages 2 through 49 years.⁸ The basis of this revised recommendation was 2-fold: 1) evidence of LAIV effectiveness comparable to that of inactivated products against A (H3N2) and B viruses; and 2) evidence that a new strain of A (H1N1) now used to produce the vaccine (A/Slovenia) produces a significantly higher antibody response than the strain (A/Bolivia) used in the years when the vaccine was not effective against A (H1N1).

However, the new formulation’s clinical effectiveness against A (H1N1) has not been demonstrated, leading the American Academy of Pediatrics to recommend that LAIV should be used in children only if other options are not available or if injectable vaccine is refused.⁹ Contraindications to the use of LAIV remain the same as the previous version of the vaccine (TABLE 1⁶).

Individuals with non-severe egg allergies can receive any licensed, recommended age-appropriate influenza vaccine and no longer have to be monitored for 30 minutes after receiving the vaccine. People who have severe egg allergies should be vaccinated with an egg-free product or in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions.

Continue to: Children 6 months through 8 years...

Children 6 months through 8 years who have previously received an influenza vaccine, either trivalent or quadrivalent, need only 1 dose; those who have not received vaccination need 2 doses separated by at least 4 weeks.

Available vaccine products

A table found on the CDC influenza Web site lists the vaccine products available in the United States and the ages for which they are approved.⁶ The options now include 2 standard-dose trivalent inactivated influenza vaccines (IIV3), 4 standard-dose quadrivalent inactivated influenza vaccines (IIV4), one cell culture-based IIV4 (ccIIV4), one standard dose IIV4 intradermal option, a trivalent and a quadrivalent recombinant influenza vaccine (RIV3, RIV4), one LAIV, and 2 products for those 65 years and older—an adjuvanted IIV3 (aIIV3) and a high dose IIV3. Three of these products do not depend on egg-based technology: RIV3, RIV4, and ccIIV4.

Comparative effectiveness studies of these vaccine options, including those available for the elderly, are being conducted. Studies presented at the June 2018 ACIP meeting show comparable effectiveness of egg-based and non–egg-based products.⁶ At this time, ACIP does not make a preferential recommendation for any influenza vaccine product for any age group.

The 2017-2018 influenza season was one of the most severe in this century, according to every indicator measured by the Centers for Disease Control and Prevention (CDC). The proportion of outpatient visits due to influenza-like illness (ILI) was elevated nationally above a baseline of 2.2% for 19 straight weeks, and for 3 weeks it was over 7%.¹ High ILI activity was widespread and included all 50 states in January.

From October 2017 through April 2018, the CDC estimates that the influenza-related hospitalization rate was 106.6 per 100,000 population, with the highest rates among children 0 to 4 years (74.3/100,000), adults 50 to 64 years (115.7/100,000), and adults 65 years and older (460.9/100,000). More than 90% of adults hospitalized had a chronic condition, such as heart or lung disease, diabetes, or obesity, placing them at high risk for influenza complications.¹

Influenza severity is also measured as the proportion of deaths due to pneumonia and influenza, which was above the epidemic threshold for 16 weeks in 2017-2018 and was above 10% for 4 weeks in January.¹ Based on all of these indicators, the 2017-2018 influenza season was classified as high severity overall and for all age groups, the first time this has happened since the 2003-2004 season. There were 171 pediatric deaths attributed to influenza, and more than three-quarters of vaccine-eligible children who died from influenza this season had not received influenza vaccine.¹

The type of influenza predominating last season was influenza A from early- through mid-season, and was influenza B later in the season (see https://stacks.cdc.gov/view/cdc/54974).¹ For the entire season, 71.2% of specimens that tested positive for influenza in public health labs were Influenza A and 84.9% of these were H3N2.¹

Effectiveness of influenza vaccine last season. As measured by preventing respiratory illness needing medical attention, vaccine effectiveness was 36% overall: 25% against influenza A (H3N2), 67% against influenza A (H1N1), and 42% against influenza B.¹ Effectiveness varied by age, being the highest in those 8 years and younger.² Effectiveness was questionable in those older than 65, with an estimated effectiveness of 23% but confidence intervals including 0.²

While the effectiveness of influenza vaccines remains suboptimal, the morbidity and mortality they prevent is still considerable. The CDC estimates that in 2016-2017, more than 5 million influenza illnesses, 2.6 million medical visits, and 84,700 hospitalizations were prevented.³ And effectiveness last season was similar to, or better than, what has been seen in each of the past 10 years (FIGURE).⁴

Three drugs were recommended for use to treat influenza in 2017-1018 (oseltamivir, peramivir, and zanamivir), and no resistance was found except in 1% of influenza A (H1N1) tested.¹ No resistance was found in other A or any B viruses tested.¹

Continue to: Safety

The safety of influenza vaccines is studied each year by both the CDC and US Food and Drug Administration (FDA). This past year, studies were conducted using the CDC-supported Safety Datalink System, looking for increased rates of acute disseminated encephalomyelitis, anaphylaxis, Bell’s palsy, encephalitis, Guillain-Barré syndrome (GBS), seizures, and transverse myelitis.⁵ No safety signals were detected. However, for some of the newer vaccines, the numbers of vaccinated individuals studied were small. The FDA studied the incidence of GBS using Medicare data and found no increased rates in those vaccinated.⁵

2018-2019 Recommendations

There are only a few changes to the recommendations for the upcoming influenza season. The Advisory Committee on Immunization Practices (ACIP) still recommends universal vaccination for anyone age 6 months and older who does not have a contraindication (TABLE 1⁶). Two of the antigens in the vaccines for this coming season are slightly different from last season (TABLE 2⁷).

After 2 years of recommending against the use of live attenuated influenza vaccine (LAIV) because of its low effectiveness in children against influenza A (H1N1), ACIP now includes it as an option for the upcoming season in individuals ages 2 through 49 years.⁸ The basis of this revised recommendation was 2-fold: 1) evidence of LAIV effectiveness comparable to that of inactivated products against A (H3N2) and B viruses; and 2) evidence that a new strain of A (H1N1) now used to produce the vaccine (A/Slovenia) produces a significantly higher antibody response than the strain (A/Bolivia) used in the years when the vaccine was not effective against A (H1N1).

However, the new formulation’s clinical effectiveness against A (H1N1) has not been demonstrated, leading the American Academy of Pediatrics to recommend that LAIV should be used in children only if other options are not available or if injectable vaccine is refused.⁹ Contraindications to the use of LAIV remain the same as the previous version of the vaccine (TABLE 1⁶).

Individuals with non-severe egg allergies can receive any licensed, recommended age-appropriate influenza vaccine and no longer have to be monitored for 30 minutes after receiving the vaccine. People who have severe egg allergies should be vaccinated with an egg-free product or in a medical setting and be supervised by a health care provider who is able to recognize and manage severe allergic conditions.

Continue to: Children 6 months through 8 years...

Children 6 months through 8 years who have previously received an influenza vaccine, either trivalent or quadrivalent, need only 1 dose; those who have not received vaccination need 2 doses separated by at least 4 weeks.

Available vaccine products

A table found on the CDC influenza Web site lists the vaccine products available in the United States and the ages for which they are approved.⁶ The options now include 2 standard-dose trivalent inactivated influenza vaccines (IIV3), 4 standard-dose quadrivalent inactivated influenza vaccines (IIV4), one cell culture-based IIV4 (ccIIV4), one standard dose IIV4 intradermal option, a trivalent and a quadrivalent recombinant influenza vaccine (RIV3, RIV4), one LAIV, and 2 products for those 65 years and older—an adjuvanted IIV3 (aIIV3) and a high dose IIV3. Three of these products do not depend on egg-based technology: RIV3, RIV4, and ccIIV4.

Comparative effectiveness studies of these vaccine options, including those available for the elderly, are being conducted. Studies presented at the June 2018 ACIP meeting show comparable effectiveness of egg-based and non–egg-based products.⁶ At this time, ACIP does not make a preferential recommendation for any influenza vaccine product for any age group.

The latest seasonal influenza vaccine recommendations from the Advisory Committee on Immunization Practices provide several key updates that will impact clinical practice in the 2018-2019 influenza season.

CAP53/iStockphoto.com

Of note, live attenuated influenza vaccine (LAIV; FluMist Quadrivalent) is an option, following two seasons in which the committee recommended it not be used.

ACIP also updated its recommendations for individuals with a history of egg allergy, described the vaccine strains chosen for 2018-2019 season, and detailed the changes in age indications for Afluria Quadrivalent and Fluarix Quadrivalent that have been made since publication of its previous guidelines.

Published in MMWR Recommendations and Reports, the updated ACIP recommendations reflect discussions and decisions from the three public meetings of ACIP that have taken place since the last annual update.

All individuals 6 months of age and older who have no contraindications to influenza vaccine should receive routine annual influenza vaccine, ACIP also said in its report, reinforcing a key recommendation that has been in place since 2010.

“To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations,” wrote authors of the report, including lead author Lisa A. Grohskopf, MD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Dr. Grohskopf and coauthors made no specific recommendations on which vaccine to use. They said providers should choose licensed, age-appropriate recommended vaccines expected to be available for the 2018-2019 season, including inactivated influenza vaccines (IIV), a recombinant influenza vaccine (RIV4), and the LAIV option.

FluMist Quadrivalent, the one LAIV product expected to be available for the 2018-2019 season, is licensed for individuals aged 2-49 years.

In its deliberations over the updated LAIV recommendation, ACIP reviewed observational data from previous seasons suggesting that the vaccine was poorly effective, and significantly less effective than IIV, against influenza A(H1N1) pdm09 viruses.

The current formulation of FluMist includes a new H1N1pdm09-like vaccine virus. While no effectiveness estimates were available at the time of review, ACIP said it did consider manufacturer data on shedding and immunogenicity for the current vaccine in children between the ages of 24 months through less than 4 years.

“These data suggest that this new H1N1pdm09-like virus has improved replicative fitness over previous H1N1pdm09-like viruses included in LAIV,” Dr. Grohskopf and colleagues wrote.

Individuals with an egg allergy history also can receive any licensed, recommended, age-appropriate IIV, RIV, or LAIV vaccine, said ACIP. This updated recommendation was based in part on the committee’s review and discussion of three studies that showed no cases of anaphylaxis in egg-allergic children receiving LAIV.

The ACIP recommendation update also outlines the strains selected earlier this year for the 2018-2019 season. Trivalent influenza vaccines in the United States will include an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent vaccines will include those strains plus a B/Phuket/3073/2013–like virus (Yamagata lineage).

The report also acknowledges the recent expansion of age indication for two vaccines that have occurred since the last ACIP recommendations.

Afluria Quadrivalent was previously licensed for individuals 18 years of age and older. In August 2017, the Food and Drug Administration approved expansion of the indication to individuals 5 years of age or older. In January 2018, FDA approved expansion of the Fluarix Quadrivalent indication, previously licensed for age 3 and older, to individuals 6 months and older.

Report coauthor Emmanuel B. Walter disclosed grants from Novavax and Merck. The remaining report authors reported no relevant financial disclosures.

SOURCE: Grohskopf LA et al. MMWR Recomm Rep. 2018 Aug 24;67(3):1-20.

The latest seasonal influenza vaccine recommendations from the Advisory Committee on Immunization Practices provide several key updates that will impact clinical practice in the 2018-2019 influenza season.

CAP53/iStockphoto.com

Of note, live attenuated influenza vaccine (LAIV; FluMist Quadrivalent) is an option, following two seasons in which the committee recommended it not be used.

ACIP also updated its recommendations for individuals with a history of egg allergy, described the vaccine strains chosen for 2018-2019 season, and detailed the changes in age indications for Afluria Quadrivalent and Fluarix Quadrivalent that have been made since publication of its previous guidelines.

Published in MMWR Recommendations and Reports, the updated ACIP recommendations reflect discussions and decisions from the three public meetings of ACIP that have taken place since the last annual update.

All individuals 6 months of age and older who have no contraindications to influenza vaccine should receive routine annual influenza vaccine, ACIP also said in its report, reinforcing a key recommendation that has been in place since 2010.

“To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations,” wrote authors of the report, including lead author Lisa A. Grohskopf, MD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Dr. Grohskopf and coauthors made no specific recommendations on which vaccine to use. They said providers should choose licensed, age-appropriate recommended vaccines expected to be available for the 2018-2019 season, including inactivated influenza vaccines (IIV), a recombinant influenza vaccine (RIV4), and the LAIV option.

FluMist Quadrivalent, the one LAIV product expected to be available for the 2018-2019 season, is licensed for individuals aged 2-49 years.

In its deliberations over the updated LAIV recommendation, ACIP reviewed observational data from previous seasons suggesting that the vaccine was poorly effective, and significantly less effective than IIV, against influenza A(H1N1) pdm09 viruses.

The current formulation of FluMist includes a new H1N1pdm09-like vaccine virus. While no effectiveness estimates were available at the time of review, ACIP said it did consider manufacturer data on shedding and immunogenicity for the current vaccine in children between the ages of 24 months through less than 4 years.

“These data suggest that this new H1N1pdm09-like virus has improved replicative fitness over previous H1N1pdm09-like viruses included in LAIV,” Dr. Grohskopf and colleagues wrote.

Individuals with an egg allergy history also can receive any licensed, recommended, age-appropriate IIV, RIV, or LAIV vaccine, said ACIP. This updated recommendation was based in part on the committee’s review and discussion of three studies that showed no cases of anaphylaxis in egg-allergic children receiving LAIV.

The ACIP recommendation update also outlines the strains selected earlier this year for the 2018-2019 season. Trivalent influenza vaccines in the United States will include an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent vaccines will include those strains plus a B/Phuket/3073/2013–like virus (Yamagata lineage).

The report also acknowledges the recent expansion of age indication for two vaccines that have occurred since the last ACIP recommendations.

Afluria Quadrivalent was previously licensed for individuals 18 years of age and older. In August 2017, the Food and Drug Administration approved expansion of the indication to individuals 5 years of age or older. In January 2018, FDA approved expansion of the Fluarix Quadrivalent indication, previously licensed for age 3 and older, to individuals 6 months and older.

Report coauthor Emmanuel B. Walter disclosed grants from Novavax and Merck. The remaining report authors reported no relevant financial disclosures.

SOURCE: Grohskopf LA et al. MMWR Recomm Rep. 2018 Aug 24;67(3):1-20.

The latest seasonal influenza vaccine recommendations from the Advisory Committee on Immunization Practices provide several key updates that will impact clinical practice in the 2018-2019 influenza season.

CAP53/iStockphoto.com

Of note, live attenuated influenza vaccine (LAIV; FluMist Quadrivalent) is an option, following two seasons in which the committee recommended it not be used.

ACIP also updated its recommendations for individuals with a history of egg allergy, described the vaccine strains chosen for 2018-2019 season, and detailed the changes in age indications for Afluria Quadrivalent and Fluarix Quadrivalent that have been made since publication of its previous guidelines.

Published in MMWR Recommendations and Reports, the updated ACIP recommendations reflect discussions and decisions from the three public meetings of ACIP that have taken place since the last annual update.

All individuals 6 months of age and older who have no contraindications to influenza vaccine should receive routine annual influenza vaccine, ACIP also said in its report, reinforcing a key recommendation that has been in place since 2010.

“To avoid missed opportunities for vaccination, providers should offer vaccination during routine health care visits and hospitalizations,” wrote authors of the report, including lead author Lisa A. Grohskopf, MD, of the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta.

Dr. Grohskopf and coauthors made no specific recommendations on which vaccine to use. They said providers should choose licensed, age-appropriate recommended vaccines expected to be available for the 2018-2019 season, including inactivated influenza vaccines (IIV), a recombinant influenza vaccine (RIV4), and the LAIV option.

FluMist Quadrivalent, the one LAIV product expected to be available for the 2018-2019 season, is licensed for individuals aged 2-49 years.

In its deliberations over the updated LAIV recommendation, ACIP reviewed observational data from previous seasons suggesting that the vaccine was poorly effective, and significantly less effective than IIV, against influenza A(H1N1) pdm09 viruses.

The current formulation of FluMist includes a new H1N1pdm09-like vaccine virus. While no effectiveness estimates were available at the time of review, ACIP said it did consider manufacturer data on shedding and immunogenicity for the current vaccine in children between the ages of 24 months through less than 4 years.

“These data suggest that this new H1N1pdm09-like virus has improved replicative fitness over previous H1N1pdm09-like viruses included in LAIV,” Dr. Grohskopf and colleagues wrote.

Individuals with an egg allergy history also can receive any licensed, recommended, age-appropriate IIV, RIV, or LAIV vaccine, said ACIP. This updated recommendation was based in part on the committee’s review and discussion of three studies that showed no cases of anaphylaxis in egg-allergic children receiving LAIV.

The ACIP recommendation update also outlines the strains selected earlier this year for the 2018-2019 season. Trivalent influenza vaccines in the United States will include an A/Michigan/45/2015 (H1N1) pdm09–like virus, an A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus, and a B/Colorado/06/2017–like virus (Victoria lineage). Quadrivalent vaccines will include those strains plus a B/Phuket/3073/2013–like virus (Yamagata lineage).

The report also acknowledges the recent expansion of age indication for two vaccines that have occurred since the last ACIP recommendations.

Afluria Quadrivalent was previously licensed for individuals 18 years of age and older. In August 2017, the Food and Drug Administration approved expansion of the indication to individuals 5 years of age or older. In January 2018, FDA approved expansion of the Fluarix Quadrivalent indication, previously licensed for age 3 and older, to individuals 6 months and older.

Report coauthor Emmanuel B. Walter disclosed grants from Novavax and Merck. The remaining report authors reported no relevant financial disclosures.

SOURCE: Grohskopf LA et al. MMWR Recomm Rep. 2018 Aug 24;67(3):1-20.

Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

Russian trolls and bots significantly intensified the polarization of vaccine messaging on Twitter, fostering discord on the social network, according to researchers who analyzed the content of tweets over a 3-year period.

copyright DesignPics/Thinkstock

“Bots and trolls are actively involved in the online public health discourse, skewing discussions about vaccination,” wrote David A. Broniatowski, PhD, of George Washington University, Washington, D.C., and his associates.

“Accounts masquerading as legitimate users create false equivalency, eroding public consensus on vaccination,” creating an environment in which countering vaccine skepticism actually enable bots to “legitimize the vaccine debate,” the researchers concluded in the American Journal of Public Health (Am J Public Health. doi: 10.2105/AJPH.2018.304567).

“This is vital knowledge for risk communicators, especially considering that neither members of the public nor algorithmic approaches may be able to easily identify bots, trolls, or cyborgs.”

The researchers conducted two content analyses and one qualitative analysis of tweets from July 2014 to September 2017. Their data set included 1% of all tweets during that time period and a sample of tweets containing vaccine-related keywords.

First they compared rates of vaccine-related tweets between bots and average users, and then they assessed the attitude of these tweets from different account types. Their qualitative case study focused on the use of the hashtag #vaccinateUS which was predominantly used by Russian trolls.

The researchers relied on seven publicly available lists to identify which accounts were bots or trolls and then compared them to randomly selected tweets posted in the same time period.

In their second analysis, the researchers used Botometer, a program created by the Indiana University Network Science Institute (IUNI) and the Center for Complex Networks and Systems Research (CNetS), to categorize tweets as very likely to be human, very likely to be bots, or of uncertain provenance.

Results revealed that Russian trolls, sophisticated bot accounts, and “content polluters” – those that spread malware and unsolicited content – are more likely than average users to tweet about vaccination. Content polluters tweeted more anti-vaccine messages while Russian trolls and sophisticated bots promoted both anti-vaccine and pro-vaccine messages that amplified the polarization (P less than .001).

The higher rate of antivaccine messages from content polluters suggested that antivaccine advocates may have exploited existing bot networks for their messaging.

“These accounts may also use the compelling nature of antivaccine content as clickbait to drive up advertising revenue and expose users to malware,” Dr. Broniatowski and colleagues wrote. “Antivaccine content may increase the risks of infection by both computer and biological viruses.”

The qualitative analysis of the #VaccinateUS hashtag found that 43% were provaccine, 38% were antivaccine and the other 19% were neutral.

“Whereas most non-neutral vaccine-relevant hashtags were clearly identifiable as either provaccine (#vaccineswork, #vaxwithme) or antivaccine (#Vaxxed, #b1less, #CDCWhistleblower), with limited appropriation by the opposing side, #VaccinateUS is unique in that it appears with very polarized messages on both sides,” the researchers reported.

Tweets using the #VaccinateUS hashtags were also more likely to contain grammatical errors, unnatural word choices, and irregular phrasing – but fewer spelling or punctuation errors than average tweets related to vaccines.

“The #VaccinateUS messages are also distinctive in that they contain no links to outside content, rare @mentions of other users, and no images (but occasionally use some emojis),” the researchers found.

Although messages with that hashtag “mirrored” Twitter’s overall vaccine discourse, subtle differences included greater emphasis on “freedom,” “democracy,” and “constitutional rights” than the more common “parental choice” focus of tweets using other vaccine-related hashtags. The conspiracy-theory targets of #VaccinateUS tweets also focused almost entirely on the U.S. government instead of a wide range of conspiracy theories at large, which was more common in other anti-vaccine tweets.

Antivaccine content was densest among accounts, with accounts falling in the middle bot category of uncertainty.

“Although we speculate that this set of accounts contains more sophisticated bots, trolls, and cyborgs, their provenance is ultimately unknown,” the researchers wrote. “Therefore, beyond attempting to prevent bots from spreading messages over social media, public health practitioners should focus on combating the messages themselves while not feeding the trolls.”

The research was funded by the National Institutes of Health. No conflicts of interest were noted.

SOURCE: Broniatowski DA  et al. Am J Public Health. 2018 Aug 23. doi: 10.2105/AJPH.2018.304567.

The human papillomavirus vaccine does not appear to be associated with an increased risk of ovarian insufficiency, according to researchers.

Choreograph/Thinkstock

Allison L. Naleway, PhD, of the Center for Health Research at Kaiser Permanente Northwest, Portland, Ore., and her coauthors wrote that a previous case series had raised concerns about a possible link between the human papillomavirus (HPV) vaccine and primary ovarian insufficiency (POI) in six young women who developed the condition within 12 months of vaccination.

Using EHR data, researchers identified 46 women aged 11-34 years with idiopathic POI – 33 probable cases and 13 possible cases – after excluding cases with known causes. Eighteen of these cases also were excluded because they were diagnosed before the HPV vaccine was available.

They found that only 1 of the remaining 28 patients had been vaccinated against HPV before the symptom onset: a 16-year-old girl who was vaccinated about 23 months before the first clinical evaluation for delayed menarche. Their report was published in Pediatrics.

The adjusted hazard ratio for POI was therefore 0.30 after HPV vaccine, compared with 0.88 after Tdap, 1.42 after inactivated influenza vaccine, and 0.94 after meningococcal conjugate vaccine.

More than one-half of the 46 confirmed POI cases were diagnosed at age 27 years or older, and only one patient was diagnosed under 15 years of age.

“If POI is triggered by HPV or other adolescent vaccine exposure, we would have expected to see elevated incidence in the younger women who were most likely to be vaccinated, but instead we observed higher incidence in older women (greater than 26 years of age), which is consistent with 1 other population-based study of POI prevalence,” the authors wrote.

They acknowledged that studying POI as a vaccine-related adverse event was challenging because the time from symptom onset to diagnosis was variable. However, they said that 81% of their cohort was followed up for more than 2 years, and a mean of 5.14 years, so the potential for misclassification was “minimal.”

Dr. Naleway and her associates also noted that diagnoses of POI can be difficult to accurately identify, and symptoms may be masked by oral contraceptive use.

“Despite the challenges and limitations discussed above, we believe this study should lessen concern surrounding potential impact on fertility from HPV or other adolescent vaccination,” they wrote.

The Centers for Disease Control and Prevention supported the study. Three authors declared funding from pharmaceutical companies for unrelated studies. No other conflicts of interest were declared.

SOURCE: Naleway A et al. Pediatrics 2018;42(3):e20180943.

The human papillomavirus vaccine does not appear to be associated with an increased risk of ovarian insufficiency, according to researchers.

Choreograph/Thinkstock

Allison L. Naleway, PhD, of the Center for Health Research at Kaiser Permanente Northwest, Portland, Ore., and her coauthors wrote that a previous case series had raised concerns about a possible link between the human papillomavirus (HPV) vaccine and primary ovarian insufficiency (POI) in six young women who developed the condition within 12 months of vaccination.

Using EHR data, researchers identified 46 women aged 11-34 years with idiopathic POI – 33 probable cases and 13 possible cases – after excluding cases with known causes. Eighteen of these cases also were excluded because they were diagnosed before the HPV vaccine was available.

They found that only 1 of the remaining 28 patients had been vaccinated against HPV before the symptom onset: a 16-year-old girl who was vaccinated about 23 months before the first clinical evaluation for delayed menarche. Their report was published in Pediatrics.

The adjusted hazard ratio for POI was therefore 0.30 after HPV vaccine, compared with 0.88 after Tdap, 1.42 after inactivated influenza vaccine, and 0.94 after meningococcal conjugate vaccine.

More than one-half of the 46 confirmed POI cases were diagnosed at age 27 years or older, and only one patient was diagnosed under 15 years of age.

“If POI is triggered by HPV or other adolescent vaccine exposure, we would have expected to see elevated incidence in the younger women who were most likely to be vaccinated, but instead we observed higher incidence in older women (greater than 26 years of age), which is consistent with 1 other population-based study of POI prevalence,” the authors wrote.

They acknowledged that studying POI as a vaccine-related adverse event was challenging because the time from symptom onset to diagnosis was variable. However, they said that 81% of their cohort was followed up for more than 2 years, and a mean of 5.14 years, so the potential for misclassification was “minimal.”

Dr. Naleway and her associates also noted that diagnoses of POI can be difficult to accurately identify, and symptoms may be masked by oral contraceptive use.

“Despite the challenges and limitations discussed above, we believe this study should lessen concern surrounding potential impact on fertility from HPV or other adolescent vaccination,” they wrote.

The Centers for Disease Control and Prevention supported the study. Three authors declared funding from pharmaceutical companies for unrelated studies. No other conflicts of interest were declared.

SOURCE: Naleway A et al. Pediatrics 2018;42(3):e20180943.

The human papillomavirus vaccine does not appear to be associated with an increased risk of ovarian insufficiency, according to researchers.

Choreograph/Thinkstock

Allison L. Naleway, PhD, of the Center for Health Research at Kaiser Permanente Northwest, Portland, Ore., and her coauthors wrote that a previous case series had raised concerns about a possible link between the human papillomavirus (HPV) vaccine and primary ovarian insufficiency (POI) in six young women who developed the condition within 12 months of vaccination.

Using EHR data, researchers identified 46 women aged 11-34 years with idiopathic POI – 33 probable cases and 13 possible cases – after excluding cases with known causes. Eighteen of these cases also were excluded because they were diagnosed before the HPV vaccine was available.

They found that only 1 of the remaining 28 patients had been vaccinated against HPV before the symptom onset: a 16-year-old girl who was vaccinated about 23 months before the first clinical evaluation for delayed menarche. Their report was published in Pediatrics.

The adjusted hazard ratio for POI was therefore 0.30 after HPV vaccine, compared with 0.88 after Tdap, 1.42 after inactivated influenza vaccine, and 0.94 after meningococcal conjugate vaccine.

More than one-half of the 46 confirmed POI cases were diagnosed at age 27 years or older, and only one patient was diagnosed under 15 years of age.

“If POI is triggered by HPV or other adolescent vaccine exposure, we would have expected to see elevated incidence in the younger women who were most likely to be vaccinated, but instead we observed higher incidence in older women (greater than 26 years of age), which is consistent with 1 other population-based study of POI prevalence,” the authors wrote.

They acknowledged that studying POI as a vaccine-related adverse event was challenging because the time from symptom onset to diagnosis was variable. However, they said that 81% of their cohort was followed up for more than 2 years, and a mean of 5.14 years, so the potential for misclassification was “minimal.”

Dr. Naleway and her associates also noted that diagnoses of POI can be difficult to accurately identify, and symptoms may be masked by oral contraceptive use.

“Despite the challenges and limitations discussed above, we believe this study should lessen concern surrounding potential impact on fertility from HPV or other adolescent vaccination,” they wrote.

The Centers for Disease Control and Prevention supported the study. Three authors declared funding from pharmaceutical companies for unrelated studies. No other conflicts of interest were declared.

SOURCE: Naleway A et al. Pediatrics 2018;42(3):e20180943.

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

Only one-third to one-half of physicians treating teens are discussing serogroup B meningococcal (MenB) vaccines during routine adolescent visits, survey results showed.

Rawpixel/Thinkstock

About half of pediatricians and one-third of family physicians said they always or often initiate discussion of MenB vaccines for adolescents aged 16- 18 year, according to a report on the survey published in Pediatrics.

However, it is challenging to say whether or not that level of discussion is on track with ideal clinical practice, according to Allison Kempe, MD, MPH, of the University of Colorado at Denver and Children’s Hospital Colorado, Aurora, and her coauthors. While MenB vaccines are recommended in this setting, the new Category B designation used for the recommendation indicates that the vaccines “may be administered” in the context of individual clinical decision making.

While some interpret the new Category B recommendation to mean that a discussion should always occur, others may interpret the recommendation as applicable to their own assessment of risks and benefits, without the need to involve patients and parents.

“Providers not initiating a discussion may not think the time required to discuss the MenB vaccine is justified by the risks posed by the disease or the benefits offered by these vaccines,” wrote Dr. Kempe and her associates. “Alternatively, they may have a low level of awareness regarding the disease or the MenB vaccine and feel insufficiently knowledgeable to have an informed discussion about the pros and cons of vaccination. They also may have been entirely unaware of the ACIP [Advisory Committee on Immunization Practices] recommendation for MenB vaccination.”

Dr. Kempe and her colleagues invited a nationally representative sample of primary care physicians to complete the survey, which was administered via Internet or mail between October and December 2016. They heard back from 374 of 475 (79%) pediatricians and 286 of 441 (65%) family physicians.

A total of 50% of pediatricians and 31% of family physicians said they always or often discussed MenB vaccines during routine visits with adolescents aged 16-18 years, with slightly higher percentages saying they initiated discussions during precollege physical exams, according to the report. Of the pediatricians, 58% recommended the MenB vaccine to those in this age group, compared with 50% of family physicians. Not all physicians who recommended the vaccine reported consistently initiating a discussion about it.

Nearly three-fourths of pediatricians and 41% of family physicians reported currently administering the MenB vaccine in their practices, the authors said, adding that greater awareness of disease outbreaks was linked to higher likelihood of discussing the vaccine, while working in an HMO setting was linked to lower likelihood of initiating that discussion.

Recommending MenB vaccination was closely tied to discussing the vaccine. Physicians who said they initiated discussion almost always reported making a recommendation to vaccinate, and conversely, those who rarely initiated discussions were unlikely to recommend it, according to Dr. Kempe and her colleagues.

Factors that made physicians more likely to recommend vaccine included awareness of outbreaks, effectiveness and safety data, and duration of vaccine protection.

The Category B recommendation, on the other hand, was one of the key factors that made physicians less likely to recommend MenB vaccine, according to this survey. ACIP made the Category B recommendation in October 2015, stating that those aged 16- 23 years may be vaccinated, with a preferred age of 16-18 years for administration. The accompanying rationale for the Category B designation referenced the low disease prevalence and insufficient data on effectiveness and safety for the two vaccines, which were both licensed under an accelerated approval mechanism following the outbreaks that have occurred on college campuses.

The Centers for Disease Control and Prevention did not provide additional guidance on how that Category B recommendation should be implemented, Dr. Kempe and her coauthors noted in their report.

“With our data, we highlight the challenges providers face with implementing recommendations for vaccination based on individual clinical decision making when they have limited experience with a disease and limited knowledge of a new vaccine,” they wrote.

The research was funded by the CDC. Dr. Kempe and her coauthors reported no relevant financial relationships or potential conflicts of interest.

SOURCE: Kempe A et al. Pediatrics. 2018 Aug 20. doi: 10.1542/peds.2018-0344.

A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases

[email protected]

SOURCE: NIH, August 16, 2018. News Release.

A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases

[email protected]

SOURCE: NIH, August 16, 2018. News Release.

A first-in-human trial of a live, attenuated Zika virus vaccine has begun, according to an announcement by the National Institutes of Health.

Courtesy National Institute of Allergy and Infectious Diseases

[email protected]

SOURCE: NIH, August 16, 2018. News Release.

MALMO, SWEDEN – A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

[email protected]

MALMO, SWEDEN – A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

[email protected]

MALMO, SWEDEN – A French national study has documented a sharp increase in pneumococcal meningitis since 2015 in children under age 15 years.

Bruce Jancin/MDedge News

The culprit has been identified as serotype 24F, which is not covered by the infant 13-valent conjugate pneumococcal vaccine (PCV13), Naim Ouldali, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.

The rapid emergence of serotype 24F has been accompanied by a disturbing change in its penicillin susceptibility. Indeed, penicillin resistance was present in only 18% of serotype 24F isolates in France during 2000-2014, then jumped to 74% during 2015-2016, according to Dr. Ouldali of René Descartes University in Paris.

“PCV13 has strongly reduced the pneumococcal meningitis burden in children, but its benefit now seems to be jeopardized, at least in France. So serum 24F could become a major concern in the coming years because of its characteristics. And now the question is, is this emergence an epidemic phenomenon or not? And if it’s confirmed in future studies and in other countries, probably it should drive the development of next-generation PCV formulations,” he said.

Dr. Ouldali presented a population-based interrupted time-series analysis of a nationwide prospective survey conducted in France during 2001-2016. He noted that the Cochrane Collaboration has deemed this study design second only to the randomized controlled trial in terms of quality of evidence.

The study, which included 227 French pediatric wards and 168 microbiology departments, identified 1,778 children under age 15 years with pneumococcal meningitis. This is believed to be more than 60% of all cases that occurred in the country during the study years.

The purpose of the study was to determine the impact of implementation of routine PCV13 as part of the national vaccine strategy. Rates of PCV13 coverage in French children are very high: in excess of 90% during 2015 to 2016.

Implementation of PCV13 led to a dramatic 38% reduction in the monthly incidence of pneumococcal meningitis, from 0.12 cases per 100,000 children before PCV13 to a low of 0.07 cases per 100,000 in December 2014. But after that the rate rebounded sharply, by 2.3% per month during 2015-2016, to a high of 0.13 cases per 100,000 per month by the end of 2016. Drilling down into the data, Dr. Ouldali and his coinvestigators learned that the resurgence of pneumococcal meningitis was due largely to the emergence of serotype 24F.

“This serotype is of particular concern because of two characteristics: First, it is already known to have a high disease potential – one of the highest, along with serotype 12F – and second, this rapid emergence was accompanied by a change in its penicillin susceptibility,” he noted.

Most of the French rebound in pneumococcal meningitis has occurred in children under 2 years of age. Of note, German investigators also have recently reported a rebound in invasive pneumococcal disease in German children under 16 years of age. Non-PCV13 serotypes accounted for 84% of all invasive pneumococcal disease during 2015-2016, with serotypes 10A and 24F leading the way. As in France, most of the resurgence has involved children less than 2 years old. However, unlike in France, most of the German increase has been in nonmeningitis forms of invasive pneumococcal disease (Vaccine. 2018 Jan 25;36[4]:572-7).

In response to a question from a concerned audience member, Dr. Ouldali said that while the penicillin susceptibility of serotype 24F has taken a sharp turn for the worse, cephalosporin susceptibility has not.

“To date, we have not seen any cephalosporin-resistant strains. To date, there is no need to use vancomycin,” he said.

Dr. Ouldali said the next step he and his colleagues plan to take is to see if there is a clonal expansion or a particular underlying genetic pattern which could explain the explosive emergence of 24F.

The study was funded by a research grant from Pfizer and by the French Pediatric Infectious Diseases Group.

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A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.

A retrospective cohort study in more than 80,000 children has found no evidence of an increased risk of autism spectrum disorder associated with prenatal tetanus, diphtheria, and acellular pertussis (Tdap) immunization.

Piotr Marcinski/Thinkstock

Of 81,993 children born between 2011 and 2014, 1,341 children (1.6%) were diagnosed with autism spectrum disorder. The incidence of autism spectrum disorder was 3.78 per 1,000 person-years in the Tdap-vaccinated group, and 4.05 per 1,000 person years in the unvaccinated group, representing an unadjusted hazard ratio of 0.98 and an adjusted hazard ratio of 0.85. This was consistent across all the birth cohorts.

Prenatal immunization rates with the prenatal Tdap vaccine ranged from 26% of the 2012 birth cohort to 79% of the 2014 birth cohort, and mean gestational age at vaccination was 28 weeks.

Tracy A. Becerra-Culqui, PhD, MPH, and colleagues of the department of research and evaluation at Kaiser Permanente Southern California, Pasadena, said this was the first study to look at the risk of autism spectrum disorder after maternal exposure to the Tdap vaccine, to their knowledge. “Our results potentially indicate that the maternal Tdap vaccine affects immune trajectories protecting infants against infections that would otherwise lead to neurodevelopmental alterations.”

They highlighted several strengths of their study. One was that maternal Tdap vaccination and information on autism spectrum disorder both were derived from EHRs and therefore not subject to recall bias. The study, published online in Pediatrics, also included children diagnosed with autism spectrum disorder from age 1 year onwards, reflecting the latest evidence on screening and diagnosis of autism.

“Our weighting procedures enabled us to balance the Tdap-exposed and -unexposed groups to compare two populations that were comparable in important measured confounding factors,” Dr. Becerra-Culqui and associates noted.

The investigators found that women who received the Tdap vaccine during pregnancy were more likely to be Asian American or Pacific Islander, to have a bachelor’s degree or higher, be nulliparous, to have also been vaccinated prenatally against influenza, and to deliver at term, compared with unvaccinated women.

However the authors did note that their follow-up was limited to 6.5 years for the earliest birth cohort, and 3.5 years for the latest cohort, so they may not have picked up children who received a later diagnosis of autism spectrum disorder.

The study was supported by Kaiser Permanente Southern California. Five authors declared funding from GlaxoSmithKline, Bayer AG, or the Centers for Disease Control and Prevention for unrelated or separate studies.

SOURCE: Becerra-Culqui T et al. Pediatrics. 2018;142(3):e20180120.