Vaccines

Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.

Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.

Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.

To help contain the outbreaks, the CDC is fast-tracking development of a novel oral polio vaccine, OPV2, through the Emergency Use Listing. The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.

The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.

A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.

Dr. Cochi had no relevant financial conflicts to disclose.

Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.

Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.

Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.

To help contain the outbreaks, the CDC is fast-tracking development of a novel oral polio vaccine, OPV2, through the Emergency Use Listing. The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.

The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.

A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.

Dr. Cochi had no relevant financial conflicts to disclose.

Although wild poliovirus type 3 has not been detected globally for 7 years, the number of wild type 1 cases increased from 33 in 2018 to 173 in 2019. In response, a modified oral vaccine is being developed, according to Stephen Cochi, MD, of the Centers for Disease Control and Prevention’s Center for Global Health.

Several factors, including a Taliban ban on house-to-house vaccination in Afghanistan and a delay of large-scale vaccinations in Pakistan contributed to the surge in polio infections, Dr. Cochi said in a presentation at the February meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP).

In addition, circulating vaccine-derived polioviruses (cVDPV) outbreaks have occurred in multiple countries including sub-Saharan Africa, China, Pakistan, and the Philippines. These outbreaks threaten the success of the bivalent oral polio vaccine introduced in April 2016 in 155 countries, Dr. Cochi said.

Outbreaks tend to occur just outside targeted areas for campaigns, caused by decreasing population immunity, he said.

To help contain the outbreaks, the CDC is fast-tracking development of a novel oral polio vaccine, OPV2, through the Emergency Use Listing. The novel OPV2 (nOPV2) is a genetic modification of the existing OPV2 vaccine designed to improve genetic stability, Dr. Cochi explained. The modifications would “decrease the risk of seeding new cVDPVs and the risk of vaccine-associated paralytic poliomyelitis (VAPP),” he said.

The Emergency Use Listing (EUL) was developed by the World Health Organization in response to the Ebola virus outbreak in 2014-2016 and is the fastest way to obtain regulatory review and approval of drug products, said Dr. Cochi.

A pilot plant has been established in Indonesia, and upon EUL approval, 4-8 million doses of the nOPV2 should be available for use in the second quarter of 2020, he concluded.

Dr. Cochi had no relevant financial conflicts to disclose.

Every year the Advisory Committee on Immunization Practices (ACIP) updates the recommended immunization schedules for children/adolescents and adults on the Web site of the Centers for Disease Control and Prevention (www.cdc.gov/vaccines/schedules/hcp/index.html). The schedules for 2020 reflect additions and changes adopted by ACIP in 2019 and are discussed in this Practice Alert.

Hepatitis A: New directives on homelessness, HIV, and vaccine catch-up

Hepatitis A (HepA) vaccination is recommended for children ages 12 to 23 months, and for those at increased risk for hepatitis A virus (HAV) infection or for complications from HAV infection (TABLE 1).^1-3 Routine vaccination is either 2 doses of HepA given 6 months apart or a 3-dose schedule of combined hepatitis A and B vaccine (Twinrix). Vaccines licensed in the United States for the prevention of HAV infection are listed in TABLE 2.¹

ACIP recently added homeless individuals to the list of those who should receive HepA vaccine.⁴ This step was taken in response to numerous outbreaks among those who are homeless or who use illicit drugs. These outbreaks have increased rates of HAV infection overall as well as rates of hospitalization (71%) and death (3%) among those infected.⁵ Concern about a homeless individual’s ability to complete a 2- or 3-dose series should not preclude initiating HepA vaccination; even 1 dose achieves protective immunity in 94% to 100% of those who have intact immune systems.²

At its June 2019 meeting, ACIP made 2 other additions to its recommendations regarding HepA vaccination.¹ First, those infected with the human immunodeficiency virus (HIV) are now among the individuals who should receive HepA vaccine. Those who are HIV-positive and ≥ 1 year old were recommended for HepA vaccination because they often have one of the other risks for HAV infection and have higher rates of complications and prolonged infections if they contract HAV.¹ Second, catch-up HepA vaccination is indicated for children and adolescents ages 2 through 18 years who have not been previously vaccinated.¹Also at the June 2019 meeting, the safety of HepA vaccination during pregnancy was confirmed. ACIP recommends HepA vaccine for any pregnant woman not previously vaccinated who is at risk for HAV infection or for a severe outcome from HAV infection.¹

Japanese encephalitis: Vaccination can be accelerated

Japanese encephalitis (JE) is a serious mosquito-borne vaccine-preventable infection endemic to most of Asia and parts of the western Pacific. Most travelers to countries with endemic JE are at low risk of infection. But risk increases with prolonged visits to these areas and particularly during the JE virus transmission season (summer/fall in temperate areas; year-round in tropical climates). Risk is also heightened by traveling to, or living in, rural Asian areas, by participating in extensive outdoor activities, and by staying in accommodations without air-conditioning, screens, or bed nets.⁶

The only JE vaccine licensed in the United States is JE-VC (Ixiaro), manufactured by Valneva Austria GmbH. It is approved for use in children ≥ 2 months and adults. It requires a 2-dose series with 28 days between doses, and a booster after 1 year. ACIP recently approved an accelerated schedule for adults ages 18 to 65 years that allows the second dose to be administered as early as 7 days after the first. A full description of the epidemiology of JE and ACIP recommendations regarding ­JE-VC were published in July 2019.⁶

Meningococcal B vaccine booster doses recommended

Meningococcal B (MenB) vaccine is recommended for individuals ≥ 10 years old who are at increased risk of meningococcal infection, including those with complement deficiency, complement inhibitor use, or asplenia; microbiologists; and individuals exposed during an outbreak.⁷ It is also recommended for those ages 16 to 23 years who desire vaccination after individual clinical decision making.⁸

Continue to: Two MenB vaccines...

Consider HepA vaccine for any pregnant woman not previously vaccinated who is at risk for hepatitis A virus infection.

Two MenB vaccines are available in the United States: MenB-FHbp (Trumenba, ­Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, GlaxoSmithKline). Either MenB vaccine can be used; however, they are not interchangeable and the same product must be used for all doses an individual receives. MenB-FHbp is licensed as a 3-dose series given at 0, 1-2, and 6 months, or as a 2-dose series given at 0 and 6 months. ACIP recommends the 3-dose schedule for individuals at increased risk for meningococcal disease or for use during community outbreaks of serogroup B meningococcal disease.⁹ For healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends using the 2-dose schedule of MenB-FHbp.⁹ MenB-4C is licensed as a 2-dose series, with doses administered at least 1 month apart.

At the June 2019 meeting, ACIP voted to recommend a MenB booster dose for those who are still at increased risk 1 year following completion of a MenB primary series, followed by booster doses every 2 to 3 years thereafter for as long as increased risk remains. This recommendation was made because of a rapid waning of immunity following the primary series and subsequent booster doses. A booster dose was not recommended for those who choose to be vaccinated after clinical decision making unless they are exposed during an outbreak and it has been at least a year since they received the primary series. An interval of 6 months for the booster can be considered, depending on the outbreak situation.¹⁰

A new DTaP product, and substituting Tdap for Td is approved

Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) is recommended for children as a 3-dose primary series (2, 4, 6 months) followed by 2 booster doses (at 15-18 months and at 4-6 years). These 3 antigens are available as DTaP products solely or as part of vaccines that combine other antigens with DTaP (TABLE 3).^11,12 In addition, as a joint venture between Merck and Sanofi Pasteur, a new pediatric hexavalent vaccine containing DTaP5, polio, Haemophilus influenzae type b, and hepatitis B antigens is now available to be given at ages 2, 4, and 6 months.¹²

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is recommended for adolescents ages 11 to 12 years.¹¹ It is also recommended once for adults who have not previously received it. The exception to the single Tdap dose for adults is during pregnancy; it is recommended as a single dose during each pregnancy regardless of the previous number of Tdap doses received.¹¹

A booster dose of meningococcal-B vaccine is indicated for individuals still at increased risk 1 year after completing the MenB primary series.

Td is recommended every 10 years after Tdap given at ages 11 to 12, for protection against tetanus and diphtheria. Tdap can be substituted for one of these decennial Td boosters. Tdap can also be substituted for Td for tetanus prophylaxis after a patient sustains a wound.¹¹ The recommended single dose of Tdap for adolescents/adults also can be administered as part of a catch-up 3-dose Td series in previously unvaccinated adolescents and adults.

Continue to: It has become common...

It has become common practice throughout the country to substitute Tdap for Td when Td is indicated, even if Tdap has been received previously. ACIP looked at the safety of repeated doses of Tdap and found no safety concerns. For practicality, ACIP voted to recommend either Td or Tdap for these situations: the decennial booster, when tetanus prophylaxis is indicated in wound management, and when catch-up is needed in previously unvaccinated or inadequately vaccinated individuals who are 7 years of age and older. The resulting increase in the number of Tdap doses is not expected to have a major impact on the incidence of pertussis.¹³

Additional recommendations

Recommendations for preventing influenza in the 2019-2020 season are discussed in a previous Practice Alert.¹⁴

In 2019, ACIP also changed a previous recommendation on the routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 65 years. The new recommendation, covered in another Practice Alert, states that PCV13 should be used in immunocompetent adults ≥ 65 years only after individual clinical decision making.¹⁵

ACIP also changed its recommendations pertaining to human papillomavirus (HPV) vaccine. Catch-up vaccination is now recommended for all individuals through age 26 years. Previously catch up was recommended only for women and for men who have sex with men. And, even though use of HPV vaccine has been approved by the US Food and Drug Administration for adults ages 27 to 45 years, ACIP did not recommend its routine use in this age group but instead recommended it only after individual clinical decision making.^16,17

Every year the Advisory Committee on Immunization Practices (ACIP) updates the recommended immunization schedules for children/adolescents and adults on the Web site of the Centers for Disease Control and Prevention (www.cdc.gov/vaccines/schedules/hcp/index.html). The schedules for 2020 reflect additions and changes adopted by ACIP in 2019 and are discussed in this Practice Alert.

Hepatitis A: New directives on homelessness, HIV, and vaccine catch-up

Hepatitis A (HepA) vaccination is recommended for children ages 12 to 23 months, and for those at increased risk for hepatitis A virus (HAV) infection or for complications from HAV infection (TABLE 1).^1-3 Routine vaccination is either 2 doses of HepA given 6 months apart or a 3-dose schedule of combined hepatitis A and B vaccine (Twinrix). Vaccines licensed in the United States for the prevention of HAV infection are listed in TABLE 2.¹

ACIP recently added homeless individuals to the list of those who should receive HepA vaccine.⁴ This step was taken in response to numerous outbreaks among those who are homeless or who use illicit drugs. These outbreaks have increased rates of HAV infection overall as well as rates of hospitalization (71%) and death (3%) among those infected.⁵ Concern about a homeless individual’s ability to complete a 2- or 3-dose series should not preclude initiating HepA vaccination; even 1 dose achieves protective immunity in 94% to 100% of those who have intact immune systems.²

At its June 2019 meeting, ACIP made 2 other additions to its recommendations regarding HepA vaccination.¹ First, those infected with the human immunodeficiency virus (HIV) are now among the individuals who should receive HepA vaccine. Those who are HIV-positive and ≥ 1 year old were recommended for HepA vaccination because they often have one of the other risks for HAV infection and have higher rates of complications and prolonged infections if they contract HAV.¹ Second, catch-up HepA vaccination is indicated for children and adolescents ages 2 through 18 years who have not been previously vaccinated.¹Also at the June 2019 meeting, the safety of HepA vaccination during pregnancy was confirmed. ACIP recommends HepA vaccine for any pregnant woman not previously vaccinated who is at risk for HAV infection or for a severe outcome from HAV infection.¹

Japanese encephalitis: Vaccination can be accelerated

Japanese encephalitis (JE) is a serious mosquito-borne vaccine-preventable infection endemic to most of Asia and parts of the western Pacific. Most travelers to countries with endemic JE are at low risk of infection. But risk increases with prolonged visits to these areas and particularly during the JE virus transmission season (summer/fall in temperate areas; year-round in tropical climates). Risk is also heightened by traveling to, or living in, rural Asian areas, by participating in extensive outdoor activities, and by staying in accommodations without air-conditioning, screens, or bed nets.⁶

The only JE vaccine licensed in the United States is JE-VC (Ixiaro), manufactured by Valneva Austria GmbH. It is approved for use in children ≥ 2 months and adults. It requires a 2-dose series with 28 days between doses, and a booster after 1 year. ACIP recently approved an accelerated schedule for adults ages 18 to 65 years that allows the second dose to be administered as early as 7 days after the first. A full description of the epidemiology of JE and ACIP recommendations regarding ­JE-VC were published in July 2019.⁶

Meningococcal B vaccine booster doses recommended

Meningococcal B (MenB) vaccine is recommended for individuals ≥ 10 years old who are at increased risk of meningococcal infection, including those with complement deficiency, complement inhibitor use, or asplenia; microbiologists; and individuals exposed during an outbreak.⁷ It is also recommended for those ages 16 to 23 years who desire vaccination after individual clinical decision making.⁸

Continue to: Two MenB vaccines...

Consider HepA vaccine for any pregnant woman not previously vaccinated who is at risk for hepatitis A virus infection.

Two MenB vaccines are available in the United States: MenB-FHbp (Trumenba, ­Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, GlaxoSmithKline). Either MenB vaccine can be used; however, they are not interchangeable and the same product must be used for all doses an individual receives. MenB-FHbp is licensed as a 3-dose series given at 0, 1-2, and 6 months, or as a 2-dose series given at 0 and 6 months. ACIP recommends the 3-dose schedule for individuals at increased risk for meningococcal disease or for use during community outbreaks of serogroup B meningococcal disease.⁹ For healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends using the 2-dose schedule of MenB-FHbp.⁹ MenB-4C is licensed as a 2-dose series, with doses administered at least 1 month apart.

At the June 2019 meeting, ACIP voted to recommend a MenB booster dose for those who are still at increased risk 1 year following completion of a MenB primary series, followed by booster doses every 2 to 3 years thereafter for as long as increased risk remains. This recommendation was made because of a rapid waning of immunity following the primary series and subsequent booster doses. A booster dose was not recommended for those who choose to be vaccinated after clinical decision making unless they are exposed during an outbreak and it has been at least a year since they received the primary series. An interval of 6 months for the booster can be considered, depending on the outbreak situation.¹⁰

A new DTaP product, and substituting Tdap for Td is approved

Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) is recommended for children as a 3-dose primary series (2, 4, 6 months) followed by 2 booster doses (at 15-18 months and at 4-6 years). These 3 antigens are available as DTaP products solely or as part of vaccines that combine other antigens with DTaP (TABLE 3).^11,12 In addition, as a joint venture between Merck and Sanofi Pasteur, a new pediatric hexavalent vaccine containing DTaP5, polio, Haemophilus influenzae type b, and hepatitis B antigens is now available to be given at ages 2, 4, and 6 months.¹²

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is recommended for adolescents ages 11 to 12 years.¹¹ It is also recommended once for adults who have not previously received it. The exception to the single Tdap dose for adults is during pregnancy; it is recommended as a single dose during each pregnancy regardless of the previous number of Tdap doses received.¹¹

A booster dose of meningococcal-B vaccine is indicated for individuals still at increased risk 1 year after completing the MenB primary series.

Td is recommended every 10 years after Tdap given at ages 11 to 12, for protection against tetanus and diphtheria. Tdap can be substituted for one of these decennial Td boosters. Tdap can also be substituted for Td for tetanus prophylaxis after a patient sustains a wound.¹¹ The recommended single dose of Tdap for adolescents/adults also can be administered as part of a catch-up 3-dose Td series in previously unvaccinated adolescents and adults.

Continue to: It has become common...

It has become common practice throughout the country to substitute Tdap for Td when Td is indicated, even if Tdap has been received previously. ACIP looked at the safety of repeated doses of Tdap and found no safety concerns. For practicality, ACIP voted to recommend either Td or Tdap for these situations: the decennial booster, when tetanus prophylaxis is indicated in wound management, and when catch-up is needed in previously unvaccinated or inadequately vaccinated individuals who are 7 years of age and older. The resulting increase in the number of Tdap doses is not expected to have a major impact on the incidence of pertussis.¹³

Additional recommendations

Recommendations for preventing influenza in the 2019-2020 season are discussed in a previous Practice Alert.¹⁴

In 2019, ACIP also changed a previous recommendation on the routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 65 years. The new recommendation, covered in another Practice Alert, states that PCV13 should be used in immunocompetent adults ≥ 65 years only after individual clinical decision making.¹⁵

ACIP also changed its recommendations pertaining to human papillomavirus (HPV) vaccine. Catch-up vaccination is now recommended for all individuals through age 26 years. Previously catch up was recommended only for women and for men who have sex with men. And, even though use of HPV vaccine has been approved by the US Food and Drug Administration for adults ages 27 to 45 years, ACIP did not recommend its routine use in this age group but instead recommended it only after individual clinical decision making.^16,17

Every year the Advisory Committee on Immunization Practices (ACIP) updates the recommended immunization schedules for children/adolescents and adults on the Web site of the Centers for Disease Control and Prevention (www.cdc.gov/vaccines/schedules/hcp/index.html). The schedules for 2020 reflect additions and changes adopted by ACIP in 2019 and are discussed in this Practice Alert.

Hepatitis A: New directives on homelessness, HIV, and vaccine catch-up

Hepatitis A (HepA) vaccination is recommended for children ages 12 to 23 months, and for those at increased risk for hepatitis A virus (HAV) infection or for complications from HAV infection (TABLE 1).^1-3 Routine vaccination is either 2 doses of HepA given 6 months apart or a 3-dose schedule of combined hepatitis A and B vaccine (Twinrix). Vaccines licensed in the United States for the prevention of HAV infection are listed in TABLE 2.¹

ACIP recently added homeless individuals to the list of those who should receive HepA vaccine.⁴ This step was taken in response to numerous outbreaks among those who are homeless or who use illicit drugs. These outbreaks have increased rates of HAV infection overall as well as rates of hospitalization (71%) and death (3%) among those infected.⁵ Concern about a homeless individual’s ability to complete a 2- or 3-dose series should not preclude initiating HepA vaccination; even 1 dose achieves protective immunity in 94% to 100% of those who have intact immune systems.²

At its June 2019 meeting, ACIP made 2 other additions to its recommendations regarding HepA vaccination.¹ First, those infected with the human immunodeficiency virus (HIV) are now among the individuals who should receive HepA vaccine. Those who are HIV-positive and ≥ 1 year old were recommended for HepA vaccination because they often have one of the other risks for HAV infection and have higher rates of complications and prolonged infections if they contract HAV.¹ Second, catch-up HepA vaccination is indicated for children and adolescents ages 2 through 18 years who have not been previously vaccinated.¹Also at the June 2019 meeting, the safety of HepA vaccination during pregnancy was confirmed. ACIP recommends HepA vaccine for any pregnant woman not previously vaccinated who is at risk for HAV infection or for a severe outcome from HAV infection.¹

Japanese encephalitis: Vaccination can be accelerated

Japanese encephalitis (JE) is a serious mosquito-borne vaccine-preventable infection endemic to most of Asia and parts of the western Pacific. Most travelers to countries with endemic JE are at low risk of infection. But risk increases with prolonged visits to these areas and particularly during the JE virus transmission season (summer/fall in temperate areas; year-round in tropical climates). Risk is also heightened by traveling to, or living in, rural Asian areas, by participating in extensive outdoor activities, and by staying in accommodations without air-conditioning, screens, or bed nets.⁶

The only JE vaccine licensed in the United States is JE-VC (Ixiaro), manufactured by Valneva Austria GmbH. It is approved for use in children ≥ 2 months and adults. It requires a 2-dose series with 28 days between doses, and a booster after 1 year. ACIP recently approved an accelerated schedule for adults ages 18 to 65 years that allows the second dose to be administered as early as 7 days after the first. A full description of the epidemiology of JE and ACIP recommendations regarding ­JE-VC were published in July 2019.⁶

Meningococcal B vaccine booster doses recommended

Meningococcal B (MenB) vaccine is recommended for individuals ≥ 10 years old who are at increased risk of meningococcal infection, including those with complement deficiency, complement inhibitor use, or asplenia; microbiologists; and individuals exposed during an outbreak.⁷ It is also recommended for those ages 16 to 23 years who desire vaccination after individual clinical decision making.⁸

Continue to: Two MenB vaccines...

Consider HepA vaccine for any pregnant woman not previously vaccinated who is at risk for hepatitis A virus infection.

Two MenB vaccines are available in the United States: MenB-FHbp (Trumenba, ­Wyeth Pharmaceuticals, Inc.) and MenB-4C (Bexsero, GlaxoSmithKline). Either MenB vaccine can be used; however, they are not interchangeable and the same product must be used for all doses an individual receives. MenB-FHbp is licensed as a 3-dose series given at 0, 1-2, and 6 months, or as a 2-dose series given at 0 and 6 months. ACIP recommends the 3-dose schedule for individuals at increased risk for meningococcal disease or for use during community outbreaks of serogroup B meningococcal disease.⁹ For healthy adolescents who are not at increased risk for meningococcal disease, ACIP recommends using the 2-dose schedule of MenB-FHbp.⁹ MenB-4C is licensed as a 2-dose series, with doses administered at least 1 month apart.

At the June 2019 meeting, ACIP voted to recommend a MenB booster dose for those who are still at increased risk 1 year following completion of a MenB primary series, followed by booster doses every 2 to 3 years thereafter for as long as increased risk remains. This recommendation was made because of a rapid waning of immunity following the primary series and subsequent booster doses. A booster dose was not recommended for those who choose to be vaccinated after clinical decision making unless they are exposed during an outbreak and it has been at least a year since they received the primary series. An interval of 6 months for the booster can be considered, depending on the outbreak situation.¹⁰

A new DTaP product, and substituting Tdap for Td is approved

Diphtheria and tetanus toxoids and acellular pertussis vaccine (DTaP) is recommended for children as a 3-dose primary series (2, 4, 6 months) followed by 2 booster doses (at 15-18 months and at 4-6 years). These 3 antigens are available as DTaP products solely or as part of vaccines that combine other antigens with DTaP (TABLE 3).^11,12 In addition, as a joint venture between Merck and Sanofi Pasteur, a new pediatric hexavalent vaccine containing DTaP5, polio, Haemophilus influenzae type b, and hepatitis B antigens is now available to be given at ages 2, 4, and 6 months.¹²

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine is recommended for adolescents ages 11 to 12 years.¹¹ It is also recommended once for adults who have not previously received it. The exception to the single Tdap dose for adults is during pregnancy; it is recommended as a single dose during each pregnancy regardless of the previous number of Tdap doses received.¹¹

A booster dose of meningococcal-B vaccine is indicated for individuals still at increased risk 1 year after completing the MenB primary series.

Td is recommended every 10 years after Tdap given at ages 11 to 12, for protection against tetanus and diphtheria. Tdap can be substituted for one of these decennial Td boosters. Tdap can also be substituted for Td for tetanus prophylaxis after a patient sustains a wound.¹¹ The recommended single dose of Tdap for adolescents/adults also can be administered as part of a catch-up 3-dose Td series in previously unvaccinated adolescents and adults.

Continue to: It has become common...

It has become common practice throughout the country to substitute Tdap for Td when Td is indicated, even if Tdap has been received previously. ACIP looked at the safety of repeated doses of Tdap and found no safety concerns. For practicality, ACIP voted to recommend either Td or Tdap for these situations: the decennial booster, when tetanus prophylaxis is indicated in wound management, and when catch-up is needed in previously unvaccinated or inadequately vaccinated individuals who are 7 years of age and older. The resulting increase in the number of Tdap doses is not expected to have a major impact on the incidence of pertussis.¹³

Additional recommendations

Recommendations for preventing influenza in the 2019-2020 season are discussed in a previous Practice Alert.¹⁴

In 2019, ACIP also changed a previous recommendation on the routine use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults ≥ 65 years. The new recommendation, covered in another Practice Alert, states that PCV13 should be used in immunocompetent adults ≥ 65 years only after individual clinical decision making.¹⁵

ACIP also changed its recommendations pertaining to human papillomavirus (HPV) vaccine. Catch-up vaccination is now recommended for all individuals through age 26 years. Previously catch up was recommended only for women and for men who have sex with men. And, even though use of HPV vaccine has been approved by the US Food and Drug Administration for adults ages 27 to 45 years, ACIP did not recommend its routine use in this age group but instead recommended it only after individual clinical decision making.^16,17

Adults are interested in a dengue vaccine for themselves and their children, and physicians recognize that dengue is a public health problem, according to data from parents and physicians in Puerto Rico. Most doctors, but fewer parents, found the idea of protecting children with Dengue vaccine acceptable.

itsmejust/Thinkstock

Lack of detailed information about the vaccine is the greatest barrier to parents’ consent to vaccination, noted Ines Esquilin, MD, of the University of Puerto Rico, San Juan, in a presentation at the February meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The ACIP dengue vaccines work group reviewed data from 102 physicians in Puerto Rico, 82% of which were pediatricians, regarding potential dengue vaccination. Overall, 98% said they considered dengue a significant public health problem in Puerto Rico, and 73% said they would recommend the dengue vaccine to patients if a laboratory test with acceptable specificity were available. Among the physicians who said they would not recommend the vaccine, the most common reason (71%) was concern about the risks of vaccinating individuals with false-positive tests.

The availability of a test that can be performed in the medical office and avoid repeat visits is a major factor in the feasibility of dengue vaccination, Dr. Esquilin said.

The ACIP dengue vaccines work group also sought public opinion on the acceptability of a generic dengue vaccine through focus group sessions with parents of children aged 9-16 years in Puerto Rico, said Dr. Esquilin.

Approximately one-third of the parents said they were willing to vaccinate their children, one-third were unwilling, and one-third were unsure. The most commonly identified barriers to vaccination included lack of information or inconsistent information about the vaccine, high cost/lack of insurance coverage, time-consuming lab test to confirm infection, side effects, potential for false-positive lab results, and low vaccine effectiveness.

Motivating factors for vaccination included correct information about the vaccine, desire to prevent infection, lab-confirmed positive test, support from public health organizations, the presence of a dengue epidemic, and educational forums.

Based in part on these findings, the ACIP dengue vaccines work group noted that the need for an acceptably specific screening lab test is the greatest concern in their consideration of recommendations, and the work group expects to review a CDC assessment of laboratory tests for prevaccination screening at a future meeting.

Dr. Esquilin had no financial conflicts to disclose.

SOURCE: Esquilin E. 2020. February meeting of the CDC Advisory Committee on Immunization Practices (ACIP) presentation.

Adults are interested in a dengue vaccine for themselves and their children, and physicians recognize that dengue is a public health problem, according to data from parents and physicians in Puerto Rico. Most doctors, but fewer parents, found the idea of protecting children with Dengue vaccine acceptable.

itsmejust/Thinkstock

Lack of detailed information about the vaccine is the greatest barrier to parents’ consent to vaccination, noted Ines Esquilin, MD, of the University of Puerto Rico, San Juan, in a presentation at the February meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The ACIP dengue vaccines work group reviewed data from 102 physicians in Puerto Rico, 82% of which were pediatricians, regarding potential dengue vaccination. Overall, 98% said they considered dengue a significant public health problem in Puerto Rico, and 73% said they would recommend the dengue vaccine to patients if a laboratory test with acceptable specificity were available. Among the physicians who said they would not recommend the vaccine, the most common reason (71%) was concern about the risks of vaccinating individuals with false-positive tests.

The availability of a test that can be performed in the medical office and avoid repeat visits is a major factor in the feasibility of dengue vaccination, Dr. Esquilin said.

The ACIP dengue vaccines work group also sought public opinion on the acceptability of a generic dengue vaccine through focus group sessions with parents of children aged 9-16 years in Puerto Rico, said Dr. Esquilin.

Approximately one-third of the parents said they were willing to vaccinate their children, one-third were unwilling, and one-third were unsure. The most commonly identified barriers to vaccination included lack of information or inconsistent information about the vaccine, high cost/lack of insurance coverage, time-consuming lab test to confirm infection, side effects, potential for false-positive lab results, and low vaccine effectiveness.

Motivating factors for vaccination included correct information about the vaccine, desire to prevent infection, lab-confirmed positive test, support from public health organizations, the presence of a dengue epidemic, and educational forums.

Based in part on these findings, the ACIP dengue vaccines work group noted that the need for an acceptably specific screening lab test is the greatest concern in their consideration of recommendations, and the work group expects to review a CDC assessment of laboratory tests for prevaccination screening at a future meeting.

Dr. Esquilin had no financial conflicts to disclose.

SOURCE: Esquilin E. 2020. February meeting of the CDC Advisory Committee on Immunization Practices (ACIP) presentation.

Adults are interested in a dengue vaccine for themselves and their children, and physicians recognize that dengue is a public health problem, according to data from parents and physicians in Puerto Rico. Most doctors, but fewer parents, found the idea of protecting children with Dengue vaccine acceptable.

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Lack of detailed information about the vaccine is the greatest barrier to parents’ consent to vaccination, noted Ines Esquilin, MD, of the University of Puerto Rico, San Juan, in a presentation at the February meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The ACIP dengue vaccines work group reviewed data from 102 physicians in Puerto Rico, 82% of which were pediatricians, regarding potential dengue vaccination. Overall, 98% said they considered dengue a significant public health problem in Puerto Rico, and 73% said they would recommend the dengue vaccine to patients if a laboratory test with acceptable specificity were available. Among the physicians who said they would not recommend the vaccine, the most common reason (71%) was concern about the risks of vaccinating individuals with false-positive tests.

The availability of a test that can be performed in the medical office and avoid repeat visits is a major factor in the feasibility of dengue vaccination, Dr. Esquilin said.

The ACIP dengue vaccines work group also sought public opinion on the acceptability of a generic dengue vaccine through focus group sessions with parents of children aged 9-16 years in Puerto Rico, said Dr. Esquilin.

Approximately one-third of the parents said they were willing to vaccinate their children, one-third were unwilling, and one-third were unsure. The most commonly identified barriers to vaccination included lack of information or inconsistent information about the vaccine, high cost/lack of insurance coverage, time-consuming lab test to confirm infection, side effects, potential for false-positive lab results, and low vaccine effectiveness.

Motivating factors for vaccination included correct information about the vaccine, desire to prevent infection, lab-confirmed positive test, support from public health organizations, the presence of a dengue epidemic, and educational forums.

Based in part on these findings, the ACIP dengue vaccines work group noted that the need for an acceptably specific screening lab test is the greatest concern in their consideration of recommendations, and the work group expects to review a CDC assessment of laboratory tests for prevaccination screening at a future meeting.

Dr. Esquilin had no financial conflicts to disclose.

SOURCE: Esquilin E. 2020. February meeting of the CDC Advisory Committee on Immunization Practices (ACIP) presentation.

Antibiotic resistance in strains of Streptococcus pneumoniae has been rising since 2013 because of changing susceptibility profiles, based on data from 1,201 isolates collected from 448 children in primary care settings.

“New strains expressing capsular serotypes not included in the 13-valent pneumococcal conjugate vaccine are emerging to cause disease, and strains that acquire antibiotic resistance are increasing in frequency due to their survival of the fittest advantage,” wrote Ravinder Kaur, PhD, of Rochester (N.Y.) General Hospital Research Institute, and colleagues.

Similar Darwinian principles occurred after the introduction of PCV-7, the study authors added.

In a prospective cohort study published in Clinical Infectious Diseases, the researchers reviewed 1,201 isolates collected from the nasopharynx during healthy periods, and from the nasopharynx and middle ear fluid (MEF) during episodes of acute otitis media, in children aged 6-36 months who were seen in primary care settings.

The isolates were collected during 2006-2016 to reflect the pre- and post-PCV13 era. Children received PCV-7 from 2006 until April 2010, and received PCV-13 after April 2010.

Overall, the number of acute otitis media (AOM) cases caused by S. pneumoniae was not significantly different between the PCV-7 and PCV-13 eras, nor was the frequency of pneumococci identified in the nasopharynx during healthy visits and visits at the start of an AOM infection.

The researchers examined susceptibility using minimum inhibitory concentrations (MIC). During healthy visits, the MIC₅₀ of isolated pneumococci was low (no greater than 0.06 mcg/mL) for all four beta-lactam drugs tested. And it didn’t change significantly over the study years.

In contrast, among the nasopharyngeal and MEF isolates during AOM, the MIC₅₀ to penicillin, amoxicillin, ceftriaxone, and meropenem during 2013-2016 rose significantly, the investigators said.

A change in antibiotic susceptibility within a subtype also contributed to the development of PCV-13 resistance.

The study authors identified three serotypes that affected the changes in susceptibility in their study population. Serotypes 35B and 35F increased their beta-lactam resistance during 2013-2016, and serotype 11A had a higher MIC to quinolones and became more prevalent during 2013-2016. Those three serotypes accounted for most of the change in antibiotic susceptibility, the researchers said.

In addition, “the frequency of strains resistant to penicillin and amoxicillin decreased with the introduction of PCV-13, but rebounded to levels similar to those before PCV-13 introduction by 2015-2016,” the investigators noted.

The study findings were limited by several factors, including the homogeneous study population and potential lack of generalizability to other settings. In addition, the researchers did not study antibiotic consumption or antibiotic treatment failure, and they could not account for potential AOM cases that may have been treated in settings other than primary care.

However, the investigators said the results support the need for additional studies and attention to the development of the next generation of PCVs, the PCV-15 and PCV-20. Both include serotypes 22F and 33F, but neither includes 35B or 35F. The PCV-20 also includes 11A and 15B.

The study was supported in part by the National Institutes of Health and Sanofi Pasteur. Some isolates collected during the 2010-2013 time period were part of a study supported by Pfizer. The researchers had no relevant financial conflicts to disclose.

SOURCE: Kaur R et al. Clin Inf Dis. 2020 Feb 18. doi: 10.1093/cid/ciaa157.

Antibiotic resistance in strains of Streptococcus pneumoniae has been rising since 2013 because of changing susceptibility profiles, based on data from 1,201 isolates collected from 448 children in primary care settings.

“New strains expressing capsular serotypes not included in the 13-valent pneumococcal conjugate vaccine are emerging to cause disease, and strains that acquire antibiotic resistance are increasing in frequency due to their survival of the fittest advantage,” wrote Ravinder Kaur, PhD, of Rochester (N.Y.) General Hospital Research Institute, and colleagues.

Similar Darwinian principles occurred after the introduction of PCV-7, the study authors added.

In a prospective cohort study published in Clinical Infectious Diseases, the researchers reviewed 1,201 isolates collected from the nasopharynx during healthy periods, and from the nasopharynx and middle ear fluid (MEF) during episodes of acute otitis media, in children aged 6-36 months who were seen in primary care settings.

The isolates were collected during 2006-2016 to reflect the pre- and post-PCV13 era. Children received PCV-7 from 2006 until April 2010, and received PCV-13 after April 2010.

Overall, the number of acute otitis media (AOM) cases caused by S. pneumoniae was not significantly different between the PCV-7 and PCV-13 eras, nor was the frequency of pneumococci identified in the nasopharynx during healthy visits and visits at the start of an AOM infection.

The researchers examined susceptibility using minimum inhibitory concentrations (MIC). During healthy visits, the MIC₅₀ of isolated pneumococci was low (no greater than 0.06 mcg/mL) for all four beta-lactam drugs tested. And it didn’t change significantly over the study years.

In contrast, among the nasopharyngeal and MEF isolates during AOM, the MIC₅₀ to penicillin, amoxicillin, ceftriaxone, and meropenem during 2013-2016 rose significantly, the investigators said.

A change in antibiotic susceptibility within a subtype also contributed to the development of PCV-13 resistance.

The study authors identified three serotypes that affected the changes in susceptibility in their study population. Serotypes 35B and 35F increased their beta-lactam resistance during 2013-2016, and serotype 11A had a higher MIC to quinolones and became more prevalent during 2013-2016. Those three serotypes accounted for most of the change in antibiotic susceptibility, the researchers said.

In addition, “the frequency of strains resistant to penicillin and amoxicillin decreased with the introduction of PCV-13, but rebounded to levels similar to those before PCV-13 introduction by 2015-2016,” the investigators noted.

The study findings were limited by several factors, including the homogeneous study population and potential lack of generalizability to other settings. In addition, the researchers did not study antibiotic consumption or antibiotic treatment failure, and they could not account for potential AOM cases that may have been treated in settings other than primary care.

However, the investigators said the results support the need for additional studies and attention to the development of the next generation of PCVs, the PCV-15 and PCV-20. Both include serotypes 22F and 33F, but neither includes 35B or 35F. The PCV-20 also includes 11A and 15B.

The study was supported in part by the National Institutes of Health and Sanofi Pasteur. Some isolates collected during the 2010-2013 time period were part of a study supported by Pfizer. The researchers had no relevant financial conflicts to disclose.

SOURCE: Kaur R et al. Clin Inf Dis. 2020 Feb 18. doi: 10.1093/cid/ciaa157.

Antibiotic resistance in strains of Streptococcus pneumoniae has been rising since 2013 because of changing susceptibility profiles, based on data from 1,201 isolates collected from 448 children in primary care settings.

“New strains expressing capsular serotypes not included in the 13-valent pneumococcal conjugate vaccine are emerging to cause disease, and strains that acquire antibiotic resistance are increasing in frequency due to their survival of the fittest advantage,” wrote Ravinder Kaur, PhD, of Rochester (N.Y.) General Hospital Research Institute, and colleagues.

Similar Darwinian principles occurred after the introduction of PCV-7, the study authors added.

In a prospective cohort study published in Clinical Infectious Diseases, the researchers reviewed 1,201 isolates collected from the nasopharynx during healthy periods, and from the nasopharynx and middle ear fluid (MEF) during episodes of acute otitis media, in children aged 6-36 months who were seen in primary care settings.

The isolates were collected during 2006-2016 to reflect the pre- and post-PCV13 era. Children received PCV-7 from 2006 until April 2010, and received PCV-13 after April 2010.

Overall, the number of acute otitis media (AOM) cases caused by S. pneumoniae was not significantly different between the PCV-7 and PCV-13 eras, nor was the frequency of pneumococci identified in the nasopharynx during healthy visits and visits at the start of an AOM infection.

The researchers examined susceptibility using minimum inhibitory concentrations (MIC). During healthy visits, the MIC₅₀ of isolated pneumococci was low (no greater than 0.06 mcg/mL) for all four beta-lactam drugs tested. And it didn’t change significantly over the study years.

In contrast, among the nasopharyngeal and MEF isolates during AOM, the MIC₅₀ to penicillin, amoxicillin, ceftriaxone, and meropenem during 2013-2016 rose significantly, the investigators said.

A change in antibiotic susceptibility within a subtype also contributed to the development of PCV-13 resistance.

The study authors identified three serotypes that affected the changes in susceptibility in their study population. Serotypes 35B and 35F increased their beta-lactam resistance during 2013-2016, and serotype 11A had a higher MIC to quinolones and became more prevalent during 2013-2016. Those three serotypes accounted for most of the change in antibiotic susceptibility, the researchers said.

In addition, “the frequency of strains resistant to penicillin and amoxicillin decreased with the introduction of PCV-13, but rebounded to levels similar to those before PCV-13 introduction by 2015-2016,” the investigators noted.

The study findings were limited by several factors, including the homogeneous study population and potential lack of generalizability to other settings. In addition, the researchers did not study antibiotic consumption or antibiotic treatment failure, and they could not account for potential AOM cases that may have been treated in settings other than primary care.

However, the investigators said the results support the need for additional studies and attention to the development of the next generation of PCVs, the PCV-15 and PCV-20. Both include serotypes 22F and 33F, but neither includes 35B or 35F. The PCV-20 also includes 11A and 15B.

The study was supported in part by the National Institutes of Health and Sanofi Pasteur. Some isolates collected during the 2010-2013 time period were part of a study supported by Pfizer. The researchers had no relevant financial conflicts to disclose.

SOURCE: Kaur R et al. Clin Inf Dis. 2020 Feb 18. doi: 10.1093/cid/ciaa157.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

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The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

The two currently available flu vaccines specifically for older adults showed similar safety profiles, based on data from 757 individuals.

copyright Wavebreakmedia/Thinkstock

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends that age-appropriate vaccines be used when possible, said Kenneth E. Schmader, MD, professor of medicine at Duke University, Durham, N.C. However, no study to date had directly compared the safety of the trivalent high dose (HD-IIV3) and adjuvanted (aIIV3) vaccines or their impact on health-related quality of life. Dr. Schmader presented findings from a randomized trial at the February ACIP meeting.

To compare the safety of the vaccines, the researchers recruited community-dwelling volunteers aged 65 years and older who were cognitively intact, not immunosuppressed, and had no contraindications for influenza vaccination. A total of 378 individuals were randomized to aIIV3 and 379 to HD-IIV3. The average age was 72 years; 80 individuals in the aIIV3 group and 83 in the HDIIV3 group were 80 years and older. The primary outcome was moderate or severe injection site pain.

Overall, the proportion of participants with moderate or severe injection site pain was not significantly different after aIIV3 vs. HD-IIV3 (3.2% vs. 5.8%).

Nine participants in the aIIV3 group and three participants in the HD-IIV3 group experienced at least one serious adverse event, but no serious adverse events were deemed vaccine related, and the occurrence of serious adverse events was not significantly different between groups.

In addition, measures of short-term, postvaccination health-related quality of life were not significantly different between the groups. Changes in scores from day 1 prevaccination to day 3 postvaccination on the EuroQOL-5 dimensions-5 levels (EQ-5D-5L) were –0.05 for both groups.

The findings were limited in part by the lack of inclusion of older adults in nursing homes or similar settings, Dr. Schmader noted. However, the results suggest that “from the standpoint of safety, either vaccine is an acceptable option for the prevention of influenza in older adults.”

Studies comparing the immunogenicity of the vaccines are ongoing, and the data should be available within the next few months, he noted.

Dr. Schmader had no financial conflicts to disclose.

Vaccination against the Ebola virus is recommended for first responders, health care personnel, and laboratory workers deemed at high risk of exposure, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The committee voted unanimously to recommended pre-exposure vaccination with the rVSVdeltaG-ZEBOV-GP vaccine for adults aged 18 years and older who are at potential risk of exposure to the Ebola species Zaire ebolavirus because they fall into any of the following three categories:

• They are responding to an outbreak of Ebola virus disease.
• They are working as health care personnel at a federally designated Ebola Treatment Center in the United States.
• The are working in laboratories or are other staff members at biosafety-level 4 facilities in the United States.

Mary Choi, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) presented data on the safety and effectiveness of the vaccine and the work group considerations in recommending vaccination in the three target populations.

In clinical trials, the most commonly reported adverse events associated with the vaccine were arthritis and arthralgia, Dr. Choi said, but the duration of those cases was limited to months and did not persist long term.

Pre-exposure vaccination for health care personnel, laboratory workers, and support staff would provide an additional layer of protection, she explained, in addition to existing safeguards such as personal protective equipment and engineering controls at the facility. The work group’s research showed that most of the target population believed that the desirable effects of that protection outweigh potentially undesirable effects, Dr. Choi noted.

Some committee members expressed concerns about vaccination of pregnant women. But the recommendations are presented as “population based, not shared decision making,” said Sharon E. Frey, MD, of Saint Louis University in St. Louis, Missouri.

Several members noted that pregnant women should not be automatically included or excluded from vaccination if they fall into a high-risk population. And the committee agreed that additional guidance in the policy note will help assess risk and that organizations will determine the risk for their employees and whether to offer the vaccine.

The FDA approved the currently available U.S. vaccine for Ebola in 2019. Merck manufactures that vaccine.

The ACIP members had no relevant financial conflicts to disclose.

Vaccination against the Ebola virus is recommended for first responders, health care personnel, and laboratory workers deemed at high risk of exposure, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The committee voted unanimously to recommended pre-exposure vaccination with the rVSVdeltaG-ZEBOV-GP vaccine for adults aged 18 years and older who are at potential risk of exposure to the Ebola species Zaire ebolavirus because they fall into any of the following three categories:

• They are responding to an outbreak of Ebola virus disease.
• They are working as health care personnel at a federally designated Ebola Treatment Center in the United States.
• The are working in laboratories or are other staff members at biosafety-level 4 facilities in the United States.

Mary Choi, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) presented data on the safety and effectiveness of the vaccine and the work group considerations in recommending vaccination in the three target populations.

In clinical trials, the most commonly reported adverse events associated with the vaccine were arthritis and arthralgia, Dr. Choi said, but the duration of those cases was limited to months and did not persist long term.

Pre-exposure vaccination for health care personnel, laboratory workers, and support staff would provide an additional layer of protection, she explained, in addition to existing safeguards such as personal protective equipment and engineering controls at the facility. The work group’s research showed that most of the target population believed that the desirable effects of that protection outweigh potentially undesirable effects, Dr. Choi noted.

Some committee members expressed concerns about vaccination of pregnant women. But the recommendations are presented as “population based, not shared decision making,” said Sharon E. Frey, MD, of Saint Louis University in St. Louis, Missouri.

Several members noted that pregnant women should not be automatically included or excluded from vaccination if they fall into a high-risk population. And the committee agreed that additional guidance in the policy note will help assess risk and that organizations will determine the risk for their employees and whether to offer the vaccine.

The FDA approved the currently available U.S. vaccine for Ebola in 2019. Merck manufactures that vaccine.

The ACIP members had no relevant financial conflicts to disclose.

Vaccination against the Ebola virus is recommended for first responders, health care personnel, and laboratory workers deemed at high risk of exposure, according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP).

The committee voted unanimously to recommended pre-exposure vaccination with the rVSVdeltaG-ZEBOV-GP vaccine for adults aged 18 years and older who are at potential risk of exposure to the Ebola species Zaire ebolavirus because they fall into any of the following three categories:

• They are responding to an outbreak of Ebola virus disease.
• They are working as health care personnel at a federally designated Ebola Treatment Center in the United States.
• The are working in laboratories or are other staff members at biosafety-level 4 facilities in the United States.

Mary Choi, MD, of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) presented data on the safety and effectiveness of the vaccine and the work group considerations in recommending vaccination in the three target populations.

In clinical trials, the most commonly reported adverse events associated with the vaccine were arthritis and arthralgia, Dr. Choi said, but the duration of those cases was limited to months and did not persist long term.

Pre-exposure vaccination for health care personnel, laboratory workers, and support staff would provide an additional layer of protection, she explained, in addition to existing safeguards such as personal protective equipment and engineering controls at the facility. The work group’s research showed that most of the target population believed that the desirable effects of that protection outweigh potentially undesirable effects, Dr. Choi noted.

Some committee members expressed concerns about vaccination of pregnant women. But the recommendations are presented as “population based, not shared decision making,” said Sharon E. Frey, MD, of Saint Louis University in St. Louis, Missouri.

Several members noted that pregnant women should not be automatically included or excluded from vaccination if they fall into a high-risk population. And the committee agreed that additional guidance in the policy note will help assess risk and that organizations will determine the risk for their employees and whether to offer the vaccine.

The FDA approved the currently available U.S. vaccine for Ebola in 2019. Merck manufactures that vaccine.

The ACIP members had no relevant financial conflicts to disclose.

LOS ANGELES – Prevention of shingles with the Zoster Vaccine Live may reduce the risk of subsequent stroke among older adults as well, the first study to examine this association suggests. Shingles vaccination was linked to a 20% decrease in stroke risk in people younger than 80 years of age in the large Medicare cohort study. Older participants showed a 10% reduced risk, according to data released in advance of formal presentation at this week’s International Stroke Conference, sponsored by the American Heart Association.

Reductions were seen for both ischemic and hemorrhagic events.

“Our findings might encourage people age 50 or older to get vaccinated against shingles and to prevent shingles-associated stroke risk,” Quanhe Yang, PhD, lead study author and senior scientist at the Centers for Disease Control and Prevention, said in an interview.

Dr. Yang and colleagues evaluated the only shingles vaccine available at the time of the study, Zoster Vaccine Live (Zostavax). However, the CDC now calls an adjuvanted, nonlive recombinant vaccine (Shingrix) the preferred shingles vaccine for healthy adults aged 50 years and older. Shingrix was approved in 2017. Zostavax, approved in 2006, can still be used in healthy adults aged 60 years and older, the agency states.

A reduction in inflammation from Zoster Vaccine Live may be the mechanism by which stroke risk is reduced, Dr. Yang said. The newer vaccine, which the CDC notes is more than 90% effective, might provide even greater protection against stroke, although more research is needed, he added.

Interestingly, prior research suggested that, once a person develops shingles, it may be too late. Dr. Yang and colleagues showed vaccination or antiviral treatment after a shingles episode was not effective at reducing stroke risk in research presented at the 2019 International Stroke Conference.

Shingles can present as a painful reactivation of chickenpox, also known as the varicella-zoster virus. Shingles is also common; Dr. Yang estimated one in three people who had chickenpox will develop the condition at some point in their lifetime. In addition, researchers have linked shingles to an elevated risk of stroke.

To assess the vaccine’s protective effect on stroke, Dr. Yang and colleagues reviewed health records for 1.38 million Medicare recipients. All participants were aged 66 years or older, had no history of stroke at baseline, and received the Zoster Vaccine Live during 2008-2016. The investigators compared the stroke rate in this vaccinated group with the rate in a matched control group of the same number of Medicare fee-for-service beneficiaries who did not receive the vaccination. They adjusted their analysis for age, sex, race, medications, and comorbidities.

The overall decrease of 16% in stroke risk associated with vaccination included a 12% drop in hemorrhagic stroke and 18% decrease in ischemic stroke over a median follow-up of 3.9 years follow-up (interquartile range, 2.7-5.4).

The adjusted hazard ratios comparing the vaccinated with control groups were 0.84 (95% confidence interval, 0.83-0.85) for all stroke; 0.82 (95% CI, 0.81-0.83) for acute ischemic stroke; and 0.88 (95% CI, 0.84-0.91) for hemorrhagic stroke.

The vaccinated group experienced 42,267 stroke events during that time. This rate included 33,510 acute ischemic strokes and 4,318 hemorrhagic strokes. At the same time, 48,139 strokes occurred in the control group. The breakdown included 39,334 ischemic and 4,713 hemorrhagic events.

“Approximately 1 million people in the United States get shingles each year, yet there is a vaccine to help prevent it,” Dr. Yang stated in a news release. “Our study results may encourage people ages 50 and older to follow the recommendation and get vaccinated against shingles. You are reducing the risk of shingles, and at the same time, you may be reducing your risk of stroke.”

“Further studies are needed to confirm our findings of association between Zostavax vaccine and risk of stroke,” Dr. Yang said.

Because the CDC Advisory Committee on Immunization Practices recommended Shingrix vaccine only for healthy adults 50 years and older in 2017, there were insufficient data in Medicare to study the association between that vaccine and risk of stroke at the time of the current study.

“However, two doses of Shingrix are more than 90% effective at preventing shingles and postherpetic neuralgia, and higher than that of Zostavax,” Dr. Yang said.

‘Very intriguing’ research

“This is a very interesting study,” Ralph L. Sacco, MD, past president of the American Heart Association, said in a video commentary released in advance of the conference. It was a very large sample, he noted, and those older than age 60 years who had the vaccine were protected with a lower risk for both ischemic and hemorrhagic stroke.

“So it is very intriguing,” added Dr. Sacco, chairman of the department of neurology at the University of Miami. “We know things like shingles can increase inflammation and increase the risk of stroke,” Dr. Sacco said, “but this is the first time in a very large Medicare database that it was shown that those who had the vaccine had a lower risk of stroke.”

The CDC funded this study. Dr. Yang and Dr. Sacco have disclosed no relevant financial relationships.

SOURCE: Yang Q et al. ISC 2020, Abstract TP493.

This article first appeared on Medscape.com.

LOS ANGELES – Prevention of shingles with the Zoster Vaccine Live may reduce the risk of subsequent stroke among older adults as well, the first study to examine this association suggests. Shingles vaccination was linked to a 20% decrease in stroke risk in people younger than 80 years of age in the large Medicare cohort study. Older participants showed a 10% reduced risk, according to data released in advance of formal presentation at this week’s International Stroke Conference, sponsored by the American Heart Association.

Reductions were seen for both ischemic and hemorrhagic events.

“Our findings might encourage people age 50 or older to get vaccinated against shingles and to prevent shingles-associated stroke risk,” Quanhe Yang, PhD, lead study author and senior scientist at the Centers for Disease Control and Prevention, said in an interview.

Dr. Yang and colleagues evaluated the only shingles vaccine available at the time of the study, Zoster Vaccine Live (Zostavax). However, the CDC now calls an adjuvanted, nonlive recombinant vaccine (Shingrix) the preferred shingles vaccine for healthy adults aged 50 years and older. Shingrix was approved in 2017. Zostavax, approved in 2006, can still be used in healthy adults aged 60 years and older, the agency states.

A reduction in inflammation from Zoster Vaccine Live may be the mechanism by which stroke risk is reduced, Dr. Yang said. The newer vaccine, which the CDC notes is more than 90% effective, might provide even greater protection against stroke, although more research is needed, he added.

Interestingly, prior research suggested that, once a person develops shingles, it may be too late. Dr. Yang and colleagues showed vaccination or antiviral treatment after a shingles episode was not effective at reducing stroke risk in research presented at the 2019 International Stroke Conference.

Shingles can present as a painful reactivation of chickenpox, also known as the varicella-zoster virus. Shingles is also common; Dr. Yang estimated one in three people who had chickenpox will develop the condition at some point in their lifetime. In addition, researchers have linked shingles to an elevated risk of stroke.

To assess the vaccine’s protective effect on stroke, Dr. Yang and colleagues reviewed health records for 1.38 million Medicare recipients. All participants were aged 66 years or older, had no history of stroke at baseline, and received the Zoster Vaccine Live during 2008-2016. The investigators compared the stroke rate in this vaccinated group with the rate in a matched control group of the same number of Medicare fee-for-service beneficiaries who did not receive the vaccination. They adjusted their analysis for age, sex, race, medications, and comorbidities.

The overall decrease of 16% in stroke risk associated with vaccination included a 12% drop in hemorrhagic stroke and 18% decrease in ischemic stroke over a median follow-up of 3.9 years follow-up (interquartile range, 2.7-5.4).

The adjusted hazard ratios comparing the vaccinated with control groups were 0.84 (95% confidence interval, 0.83-0.85) for all stroke; 0.82 (95% CI, 0.81-0.83) for acute ischemic stroke; and 0.88 (95% CI, 0.84-0.91) for hemorrhagic stroke.

The vaccinated group experienced 42,267 stroke events during that time. This rate included 33,510 acute ischemic strokes and 4,318 hemorrhagic strokes. At the same time, 48,139 strokes occurred in the control group. The breakdown included 39,334 ischemic and 4,713 hemorrhagic events.

“Approximately 1 million people in the United States get shingles each year, yet there is a vaccine to help prevent it,” Dr. Yang stated in a news release. “Our study results may encourage people ages 50 and older to follow the recommendation and get vaccinated against shingles. You are reducing the risk of shingles, and at the same time, you may be reducing your risk of stroke.”

“Further studies are needed to confirm our findings of association between Zostavax vaccine and risk of stroke,” Dr. Yang said.

Because the CDC Advisory Committee on Immunization Practices recommended Shingrix vaccine only for healthy adults 50 years and older in 2017, there were insufficient data in Medicare to study the association between that vaccine and risk of stroke at the time of the current study.

“However, two doses of Shingrix are more than 90% effective at preventing shingles and postherpetic neuralgia, and higher than that of Zostavax,” Dr. Yang said.

‘Very intriguing’ research

“This is a very interesting study,” Ralph L. Sacco, MD, past president of the American Heart Association, said in a video commentary released in advance of the conference. It was a very large sample, he noted, and those older than age 60 years who had the vaccine were protected with a lower risk for both ischemic and hemorrhagic stroke.

“So it is very intriguing,” added Dr. Sacco, chairman of the department of neurology at the University of Miami. “We know things like shingles can increase inflammation and increase the risk of stroke,” Dr. Sacco said, “but this is the first time in a very large Medicare database that it was shown that those who had the vaccine had a lower risk of stroke.”

The CDC funded this study. Dr. Yang and Dr. Sacco have disclosed no relevant financial relationships.

SOURCE: Yang Q et al. ISC 2020, Abstract TP493.

This article first appeared on Medscape.com.

LOS ANGELES – Prevention of shingles with the Zoster Vaccine Live may reduce the risk of subsequent stroke among older adults as well, the first study to examine this association suggests. Shingles vaccination was linked to a 20% decrease in stroke risk in people younger than 80 years of age in the large Medicare cohort study. Older participants showed a 10% reduced risk, according to data released in advance of formal presentation at this week’s International Stroke Conference, sponsored by the American Heart Association.

Reductions were seen for both ischemic and hemorrhagic events.

“Our findings might encourage people age 50 or older to get vaccinated against shingles and to prevent shingles-associated stroke risk,” Quanhe Yang, PhD, lead study author and senior scientist at the Centers for Disease Control and Prevention, said in an interview.

Dr. Yang and colleagues evaluated the only shingles vaccine available at the time of the study, Zoster Vaccine Live (Zostavax). However, the CDC now calls an adjuvanted, nonlive recombinant vaccine (Shingrix) the preferred shingles vaccine for healthy adults aged 50 years and older. Shingrix was approved in 2017. Zostavax, approved in 2006, can still be used in healthy adults aged 60 years and older, the agency states.

A reduction in inflammation from Zoster Vaccine Live may be the mechanism by which stroke risk is reduced, Dr. Yang said. The newer vaccine, which the CDC notes is more than 90% effective, might provide even greater protection against stroke, although more research is needed, he added.

Interestingly, prior research suggested that, once a person develops shingles, it may be too late. Dr. Yang and colleagues showed vaccination or antiviral treatment after a shingles episode was not effective at reducing stroke risk in research presented at the 2019 International Stroke Conference.

Shingles can present as a painful reactivation of chickenpox, also known as the varicella-zoster virus. Shingles is also common; Dr. Yang estimated one in three people who had chickenpox will develop the condition at some point in their lifetime. In addition, researchers have linked shingles to an elevated risk of stroke.

To assess the vaccine’s protective effect on stroke, Dr. Yang and colleagues reviewed health records for 1.38 million Medicare recipients. All participants were aged 66 years or older, had no history of stroke at baseline, and received the Zoster Vaccine Live during 2008-2016. The investigators compared the stroke rate in this vaccinated group with the rate in a matched control group of the same number of Medicare fee-for-service beneficiaries who did not receive the vaccination. They adjusted their analysis for age, sex, race, medications, and comorbidities.

The overall decrease of 16% in stroke risk associated with vaccination included a 12% drop in hemorrhagic stroke and 18% decrease in ischemic stroke over a median follow-up of 3.9 years follow-up (interquartile range, 2.7-5.4).

The adjusted hazard ratios comparing the vaccinated with control groups were 0.84 (95% confidence interval, 0.83-0.85) for all stroke; 0.82 (95% CI, 0.81-0.83) for acute ischemic stroke; and 0.88 (95% CI, 0.84-0.91) for hemorrhagic stroke.

The vaccinated group experienced 42,267 stroke events during that time. This rate included 33,510 acute ischemic strokes and 4,318 hemorrhagic strokes. At the same time, 48,139 strokes occurred in the control group. The breakdown included 39,334 ischemic and 4,713 hemorrhagic events.

“Approximately 1 million people in the United States get shingles each year, yet there is a vaccine to help prevent it,” Dr. Yang stated in a news release. “Our study results may encourage people ages 50 and older to follow the recommendation and get vaccinated against shingles. You are reducing the risk of shingles, and at the same time, you may be reducing your risk of stroke.”

“Further studies are needed to confirm our findings of association between Zostavax vaccine and risk of stroke,” Dr. Yang said.

Because the CDC Advisory Committee on Immunization Practices recommended Shingrix vaccine only for healthy adults 50 years and older in 2017, there were insufficient data in Medicare to study the association between that vaccine and risk of stroke at the time of the current study.

“However, two doses of Shingrix are more than 90% effective at preventing shingles and postherpetic neuralgia, and higher than that of Zostavax,” Dr. Yang said.

‘Very intriguing’ research

“This is a very interesting study,” Ralph L. Sacco, MD, past president of the American Heart Association, said in a video commentary released in advance of the conference. It was a very large sample, he noted, and those older than age 60 years who had the vaccine were protected with a lower risk for both ischemic and hemorrhagic stroke.

“So it is very intriguing,” added Dr. Sacco, chairman of the department of neurology at the University of Miami. “We know things like shingles can increase inflammation and increase the risk of stroke,” Dr. Sacco said, “but this is the first time in a very large Medicare database that it was shown that those who had the vaccine had a lower risk of stroke.”

The CDC funded this study. Dr. Yang and Dr. Sacco have disclosed no relevant financial relationships.

SOURCE: Yang Q et al. ISC 2020, Abstract TP493.

This article first appeared on Medscape.com.

The standard intradermal route of delivery for Bacille Calmette–Guérin (BCG) does not necessarily generate a strong enough response from lung T-cells, the researchers say. They hypothesized that administering BCG by IV or aerosol might be more effective.

They gave a group of rhesus macaques the BGC vaccine by intradermal, aerosol, or IV routes, then assessed immune responses in blood and fluid drawn from the lungs over a 24-week follow-up. Six months after vaccination, the researchers injected the vaccinated animals with a virulent strain of Mycobacterium tuberculosis (M tuberculosis) and tracked infection and disease development over 3 months.

The IV vaccination resulted in the highest durable levels of T-cells in blood and lungs. Nine of 10 animals vaccinated via IV were highly protected; 6 showed no detectable infection in any tissue tested and 3 had only very low counts of M tuberculosis in lung tissue. All unvaccinated animals and those immunized via intradermal or aerosol routes showed signs of significantly greater infection.

Upping the dose did not improve protection. The IV BCG group showed 90% protection at a threshold as low as 50 colony-forming units (the standard human ID dose is 5 x 10⁵ CFUs).

The researchers say several unique quantitative and qualitative differences in the immune responses may underlie protection. Perhaps most noteworthy, they say, was the large population of T- cells in the tissue across all lung parenchyma lobes.

The study provides a “paradigm shift,” the researchers conclude, adding that the IV route may also improve the protective capacity of other vaccines.

The standard intradermal route of delivery for Bacille Calmette–Guérin (BCG) does not necessarily generate a strong enough response from lung T-cells, the researchers say. They hypothesized that administering BCG by IV or aerosol might be more effective.

They gave a group of rhesus macaques the BGC vaccine by intradermal, aerosol, or IV routes, then assessed immune responses in blood and fluid drawn from the lungs over a 24-week follow-up. Six months after vaccination, the researchers injected the vaccinated animals with a virulent strain of Mycobacterium tuberculosis (M tuberculosis) and tracked infection and disease development over 3 months.

The IV vaccination resulted in the highest durable levels of T-cells in blood and lungs. Nine of 10 animals vaccinated via IV were highly protected; 6 showed no detectable infection in any tissue tested and 3 had only very low counts of M tuberculosis in lung tissue. All unvaccinated animals and those immunized via intradermal or aerosol routes showed signs of significantly greater infection.

Upping the dose did not improve protection. The IV BCG group showed 90% protection at a threshold as low as 50 colony-forming units (the standard human ID dose is 5 x 10⁵ CFUs).

The researchers say several unique quantitative and qualitative differences in the immune responses may underlie protection. Perhaps most noteworthy, they say, was the large population of T- cells in the tissue across all lung parenchyma lobes.

The study provides a “paradigm shift,” the researchers conclude, adding that the IV route may also improve the protective capacity of other vaccines.

The standard intradermal route of delivery for Bacille Calmette–Guérin (BCG) does not necessarily generate a strong enough response from lung T-cells, the researchers say. They hypothesized that administering BCG by IV or aerosol might be more effective.

They gave a group of rhesus macaques the BGC vaccine by intradermal, aerosol, or IV routes, then assessed immune responses in blood and fluid drawn from the lungs over a 24-week follow-up. Six months after vaccination, the researchers injected the vaccinated animals with a virulent strain of Mycobacterium tuberculosis (M tuberculosis) and tracked infection and disease development over 3 months.

The IV vaccination resulted in the highest durable levels of T-cells in blood and lungs. Nine of 10 animals vaccinated via IV were highly protected; 6 showed no detectable infection in any tissue tested and 3 had only very low counts of M tuberculosis in lung tissue. All unvaccinated animals and those immunized via intradermal or aerosol routes showed signs of significantly greater infection.

Upping the dose did not improve protection. The IV BCG group showed 90% protection at a threshold as low as 50 colony-forming units (the standard human ID dose is 5 x 10⁵ CFUs).

The researchers say several unique quantitative and qualitative differences in the immune responses may underlie protection. Perhaps most noteworthy, they say, was the large population of T- cells in the tissue across all lung parenchyma lobes.

The study provides a “paradigm shift,” the researchers conclude, adding that the IV route may also improve the protective capacity of other vaccines.

Cervical cancer is the second most common cancer among women in lower- and middle-income countries, but universal human papillomavirus vaccination for girls would reduce new cervical cancer cases by about 90% over the next century, according to researchers.

Adding twice-lifetime cervical screening with human papillomavirus (HPV) testing would further reduce the incidence of cervical cancer, including in countries with the highest burden, the researchers reported in The Lancet.

Marc Brisson, PhD, of Laval University, Quebec City, and colleagues conducted this study using three models identified by the World Health Organization. The models were used to project reductions in cervical cancer incidence for women in 78 low- and middle-income countries based on the following HPV vaccination and screening scenarios:

• Universal girls-only vaccination at age 9 years, assuming 90% of girls vaccinated and a vaccine that is perfectly effective
• Girls-only vaccination plus cervical screening with HPV testing at age 35 years
• Girls-only vaccination plus screening at ages 35 and 45.

All three scenarios modeled would result in the elimination of cervical cancer, Dr. Brisson and colleagues found. Elimination was defined as four or fewer new cases per 100,000 women-years.

The simplest scenario, universal girls-only vaccination, was predicted to reduce age-standardized cervical cancer incidence from 19.8 cases per 100,000 women-years to 2.1 cases per 100,000 women-years (89.4% reduction) by 2120. That amounts to about 61 million potential cases avoided, with elimination targets reached in 60% of the countries studied.

HPV vaccination plus one-time screening was predicted to reduce the incidence of cervical cancer to 1.0 case per 100,000 women-years (95.0% reduction), and HPV vaccination plus twice-lifetime screening was predicted to reduce the incidence to 0.7 cases per 100,000 women-years (96.7% reduction).

Dr. Brisson and colleagues reported that, for the countries with the highest burden of cervical cancer (more than 25 cases per 100,000 women-years), adding screening would be necessary to achieve elimination.

To meet the same targets across all 78 countries, “our models predict that scale-up of both girls-only HPV vaccination and twice-lifetime screening is necessary, with 90% HPV vaccination coverage, 90% screening uptake, and long-term protection against HPV types 16, 18, 31, 33, 45, 52, and 58,” the researchers wrote.

Dr. Brisson and colleagues claimed that a strength of this study is the modeling approach, which compared three models “that have been extensively peer reviewed and validated with postvaccination surveillance data.”

The researchers acknowledged, however, that their modeling could not account for variations in sexual behavior from country to country, and the study was not designed to anticipate behavioral or technological changes that could affect cervical cancer incidence in the decades to come.

The study was funded by the WHO, the United Nations, and the Canadian and Australian governments. The WHO contributed to the study design, data analysis and interpretation, and writing of the manuscript. Two study authors reported receiving indirect industry funding for a cervical screening trial in Australia.

SOURCE: Brisson M et al. Lancet. 2020 Jan 30. doi: 10.1016/S0140-6736(20)30068-4.

Cervical cancer is the second most common cancer among women in lower- and middle-income countries, but universal human papillomavirus vaccination for girls would reduce new cervical cancer cases by about 90% over the next century, according to researchers.

Adding twice-lifetime cervical screening with human papillomavirus (HPV) testing would further reduce the incidence of cervical cancer, including in countries with the highest burden, the researchers reported in The Lancet.

Marc Brisson, PhD, of Laval University, Quebec City, and colleagues conducted this study using three models identified by the World Health Organization. The models were used to project reductions in cervical cancer incidence for women in 78 low- and middle-income countries based on the following HPV vaccination and screening scenarios:

• Universal girls-only vaccination at age 9 years, assuming 90% of girls vaccinated and a vaccine that is perfectly effective
• Girls-only vaccination plus cervical screening with HPV testing at age 35 years
• Girls-only vaccination plus screening at ages 35 and 45.

All three scenarios modeled would result in the elimination of cervical cancer, Dr. Brisson and colleagues found. Elimination was defined as four or fewer new cases per 100,000 women-years.

The simplest scenario, universal girls-only vaccination, was predicted to reduce age-standardized cervical cancer incidence from 19.8 cases per 100,000 women-years to 2.1 cases per 100,000 women-years (89.4% reduction) by 2120. That amounts to about 61 million potential cases avoided, with elimination targets reached in 60% of the countries studied.

HPV vaccination plus one-time screening was predicted to reduce the incidence of cervical cancer to 1.0 case per 100,000 women-years (95.0% reduction), and HPV vaccination plus twice-lifetime screening was predicted to reduce the incidence to 0.7 cases per 100,000 women-years (96.7% reduction).

Dr. Brisson and colleagues reported that, for the countries with the highest burden of cervical cancer (more than 25 cases per 100,000 women-years), adding screening would be necessary to achieve elimination.

To meet the same targets across all 78 countries, “our models predict that scale-up of both girls-only HPV vaccination and twice-lifetime screening is necessary, with 90% HPV vaccination coverage, 90% screening uptake, and long-term protection against HPV types 16, 18, 31, 33, 45, 52, and 58,” the researchers wrote.

Dr. Brisson and colleagues claimed that a strength of this study is the modeling approach, which compared three models “that have been extensively peer reviewed and validated with postvaccination surveillance data.”

The researchers acknowledged, however, that their modeling could not account for variations in sexual behavior from country to country, and the study was not designed to anticipate behavioral or technological changes that could affect cervical cancer incidence in the decades to come.

The study was funded by the WHO, the United Nations, and the Canadian and Australian governments. The WHO contributed to the study design, data analysis and interpretation, and writing of the manuscript. Two study authors reported receiving indirect industry funding for a cervical screening trial in Australia.

SOURCE: Brisson M et al. Lancet. 2020 Jan 30. doi: 10.1016/S0140-6736(20)30068-4.

Cervical cancer is the second most common cancer among women in lower- and middle-income countries, but universal human papillomavirus vaccination for girls would reduce new cervical cancer cases by about 90% over the next century, according to researchers.

Adding twice-lifetime cervical screening with human papillomavirus (HPV) testing would further reduce the incidence of cervical cancer, including in countries with the highest burden, the researchers reported in The Lancet.

Marc Brisson, PhD, of Laval University, Quebec City, and colleagues conducted this study using three models identified by the World Health Organization. The models were used to project reductions in cervical cancer incidence for women in 78 low- and middle-income countries based on the following HPV vaccination and screening scenarios:

• Universal girls-only vaccination at age 9 years, assuming 90% of girls vaccinated and a vaccine that is perfectly effective
• Girls-only vaccination plus cervical screening with HPV testing at age 35 years
• Girls-only vaccination plus screening at ages 35 and 45.

All three scenarios modeled would result in the elimination of cervical cancer, Dr. Brisson and colleagues found. Elimination was defined as four or fewer new cases per 100,000 women-years.

The simplest scenario, universal girls-only vaccination, was predicted to reduce age-standardized cervical cancer incidence from 19.8 cases per 100,000 women-years to 2.1 cases per 100,000 women-years (89.4% reduction) by 2120. That amounts to about 61 million potential cases avoided, with elimination targets reached in 60% of the countries studied.

HPV vaccination plus one-time screening was predicted to reduce the incidence of cervical cancer to 1.0 case per 100,000 women-years (95.0% reduction), and HPV vaccination plus twice-lifetime screening was predicted to reduce the incidence to 0.7 cases per 100,000 women-years (96.7% reduction).

Dr. Brisson and colleagues reported that, for the countries with the highest burden of cervical cancer (more than 25 cases per 100,000 women-years), adding screening would be necessary to achieve elimination.

To meet the same targets across all 78 countries, “our models predict that scale-up of both girls-only HPV vaccination and twice-lifetime screening is necessary, with 90% HPV vaccination coverage, 90% screening uptake, and long-term protection against HPV types 16, 18, 31, 33, 45, 52, and 58,” the researchers wrote.

Dr. Brisson and colleagues claimed that a strength of this study is the modeling approach, which compared three models “that have been extensively peer reviewed and validated with postvaccination surveillance data.”

The researchers acknowledged, however, that their modeling could not account for variations in sexual behavior from country to country, and the study was not designed to anticipate behavioral or technological changes that could affect cervical cancer incidence in the decades to come.

The study was funded by the WHO, the United Nations, and the Canadian and Australian governments. The WHO contributed to the study design, data analysis and interpretation, and writing of the manuscript. Two study authors reported receiving indirect industry funding for a cervical screening trial in Australia.

SOURCE: Brisson M et al. Lancet. 2020 Jan 30. doi: 10.1016/S0140-6736(20)30068-4.

Fevers were no less common or less severe when influenza vaccine was delayed 2 weeks for children receiving DTaP and pneumococcal vaccinations, according to a randomized trial.

MarianVejcik/Getty Images

An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.

In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.

There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).

However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.

Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.

Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.

The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.

Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.

“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.

The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.

Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).

Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.

Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.

The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.

[email protected]

SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.

Fevers were no less common or less severe when influenza vaccine was delayed 2 weeks for children receiving DTaP and pneumococcal vaccinations, according to a randomized trial.

MarianVejcik/Getty Images

An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.

In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.

There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).

However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.

Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.

Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.

The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.

Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.

“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.

The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.

Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).

Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.

Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.

The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.

[email protected]

SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.

Fevers were no less common or less severe when influenza vaccine was delayed 2 weeks for children receiving DTaP and pneumococcal vaccinations, according to a randomized trial.

MarianVejcik/Getty Images

An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.

In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.

There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).

However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.

Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.

Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.

The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.

Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.

“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.

The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.

Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).

Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.

Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.

The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.

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SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.