Guidelines

ACIP recommends ‘shared clinical decision-making’ for HPV, pneumococcal vaccines

The CDC’s Advisory Committee on Immunization Practices, or ACIP, recommended that HPV and pneumococcal vaccination in older patients be “based on shared clinical decision-making” — that is, doctors and patients should decide whether it is appropriate.

Months after the FDA expanded approval for the HPV 9-valent vaccine (Gardasil 9, Merck) to include adults aged 27 to 45 years, the ACIP voted unanimously to raise the upper age for catch-up vaccination in men to age 26 years — in harmony with the recommendation for women — but it stopped short of making a recommendation beyond that, voting 10-4 that patients up to age 45 years speak with their doctors about receiving the vaccine.

In a close vote, ACIP members decided not to recommend the 13- valent pneumococcal conjugate vaccine (Prevnar13, Pfizer; PCV13) for all adults age 65 years or older who have not previously received it, reversing a 2014 recommendation. Instead, they recommended that the decision be left to doctors and patients.

José R. Romero

“This is going to be a frequent issue that the ACIP is going to be dealing with in the future as vaccines become more complex and more targeted for certain populations,” ACIP chair José R. Romero, MD, FAAP, director of the pediatric infectious diseases section at the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital, said at the meeting.

The 8-6 vote against recommending PCV13 for all older adults followed continued reductions in PCV13-type disease due to the indirect effects from pediatric PCV13 use. The committee voted 13-1 to recommend that doctors and patients decide if PCV13 should be administered in adults aged 65 years or older who do not have an immunocompromising condition and who have not previously received PCV13. It recommends that all adults aged 65 years or older receive a dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23).

HAV catch-up vaccination in kids

In another vote, the ACIP unanimously recommended that children and adolescents aged 2 to 18 years be vaccinated against hepatitis A virus if they have not already received the vaccine, and that all patients aged at least 1 year with HIV be vaccinated against HAV.

The ACIP has recommended since 2006 that all children be vaccinated against HAV between their first and second birthday. But until the new vote, it has said that older children be “considered” only for catch-up vaccination.

Routine HAV vaccination also is recommended in several at-risk groups, including men who have sex with men, people who use drugs, patients with chronic liver disease and people who are experiencing homelessness, a new indication added last year. Patients with HIV are now added to that group.

The votes came amid a multistate outbreak of HAV that is occurring mostly in drug users and people experiencing homelessness. HAV infections have increased almost 300% in recent years, according to researchers.

The ACIP also voted unanimously to recommend that patients aged 10 years or older with complement deficiency, complement inhibitor use, asplenia or who are microbiologists receive a meningococcal B booster dose 1 year following completion of a meningococcal B primary series, followed by booster doses every 2 to 3 years afterward for as long as the risk remains.

Hexavalent vaccine added to VFC

ACIP members voted unanimously to include all parts of a hexavalent vaccine — DTaP, polio, Haemophilus influenzae B and hepatitis B — in the Vaccines for Children (VFC) program, a federally funded arrangement in which the CDC buys discounted vaccines that are then distributed to physicians and clinics and offered at no cost to children whose families cannot afford vaccination.

The vote allows the vaccine to be included in the infant series at ages 2, 4 and 6 months through the program.

Although the vaccine was approved and licensed by the FDA in December 2018, the manufacturers — Merck and Sanofi Pasteur — have said it will not be commercially available until 2021. – by Joe Gramigna, Gerard Gallagher and Katherine Bortz

Disclosures: ACIP voting members report no relevant financial disclosures.

The CDC’s Advisory Committee on Immunization Practices, or ACIP, recommended that HPV and pneumococcal vaccination in older patients be “based on shared clinical decision-making” — that is, doctors and patients should decide whether it is appropriate.

Months after the FDA expanded approval for the HPV 9-valent vaccine (Gardasil 9, Merck) to include adults aged 27 to 45 years, the ACIP voted unanimously to raise the upper age for catch-up vaccination in men to age 26 years — in harmony with the recommendation for women — but it stopped short of making a recommendation beyond that, voting 10-4 that patients up to age 45 years speak with their doctors about receiving the vaccine.

In a close vote, ACIP members decided not to recommend the 13- valent pneumococcal conjugate vaccine (Prevnar13, Pfizer; PCV13) for all adults age 65 years or older who have not previously received it, reversing a 2014 recommendation. Instead, they recommended that the decision be left to doctors and patients.

José R. Romero

“This is going to be a frequent issue that the ACIP is going to be dealing with in the future as vaccines become more complex and more targeted for certain populations,” ACIP chair José R. Romero, MD, FAAP, director of the pediatric infectious diseases section at the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital, said at the meeting.

The 8-6 vote against recommending PCV13 for all older adults followed continued reductions in PCV13-type disease due to the indirect effects from pediatric PCV13 use. The committee voted 13-1 to recommend that doctors and patients decide if PCV13 should be administered in adults aged 65 years or older who do not have an immunocompromising condition and who have not previously received PCV13. It recommends that all adults aged 65 years or older receive a dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23).

HAV catch-up vaccination in kids

In another vote, the ACIP unanimously recommended that children and adolescents aged 2 to 18 years be vaccinated against hepatitis A virus if they have not already received the vaccine, and that all patients aged at least 1 year with HIV be vaccinated against HAV.

The ACIP has recommended since 2006 that all children be vaccinated against HAV between their first and second birthday. But until the new vote, it has said that older children be “considered” only for catch-up vaccination.

Routine HAV vaccination also is recommended in several at-risk groups, including men who have sex with men, people who use drugs, patients with chronic liver disease and people who are experiencing homelessness, a new indication added last year. Patients with HIV are now added to that group.

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The votes came amid a multistate outbreak of HAV that is occurring mostly in drug users and people experiencing homelessness. HAV infections have increased almost 300% in recent years, according to researchers.

The ACIP also voted unanimously to recommend that patients aged 10 years or older with complement deficiency, complement inhibitor use, asplenia or who are microbiologists receive a meningococcal B booster dose 1 year following completion of a meningococcal B primary series, followed by booster doses every 2 to 3 years afterward for as long as the risk remains.

Hexavalent vaccine added to VFC

ACIP members voted unanimously to include all parts of a hexavalent vaccine — DTaP, polio, Haemophilus influenzae B and hepatitis B — in the Vaccines for Children (VFC) program, a federally funded arrangement in which the CDC buys discounted vaccines that are then distributed to physicians and clinics and offered at no cost to children whose families cannot afford vaccination.

The vote allows the vaccine to be included in the infant series at ages 2, 4 and 6 months through the program.

Although the vaccine was approved and licensed by the FDA in December 2018, the manufacturers — Merck and Sanofi Pasteur — have said it will not be commercially available until 2021. – by Joe Gramigna, Gerard Gallagher and Katherine Bortz

Disclosures: ACIP voting members report no relevant financial disclosures.