Elizabeth (Izzy) Montgomery, MPA
Today, a key advisory group to the U.S. Food and Drug Administration (FDA) recommended that the Pfizer COVID-19 vaccine be authorized for use in children ages 5 to 11.Â Next week, an advisory committee to the Centers for Disease Control and Prevention (CDC) will also convene to address this issue. But what are the roles of these advisory committees, and what is the process for these vaccines to be authorized for certain groups like younger children?
The vaccine advisory committee to the FDA is known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC). VRBPAC is charged with evaluating data regarding the safety, effectiveness, and appropriate use of vaccines and related biological products. VRBPAC advises the FDA commissioner or the commissioner’s designee in performing responsibilities related to vaccines.
The VRBPAC has 15 core voting members (including the committee chair) selected by the FDA commissioner or the commissioner’s designee. Patient representatives and expert consultants are often added as temporary voting members. The voting members are leading authorities in the fields of immunology, molecular biology, virology, vaccine policy, vaccine safety science, and other key vaccine-related disciplines. VRBPAC makes a recommendation to the FDA on whether emergency use authorization should be granted for a vaccine candidate, with the FDA typically adopting the recommendation.
The Advisory Committee on Immunization Practices (ACIP) is a committee within the CDC that is comprised of medical and public health experts and is charged with reviewing vaccine clinical trial data to establish vaccine recommendations for children and adults. Recommendations from ACIP stand as public health guidance for the safe use of vaccines and related biological products.
ACIP has 15 voting members, including 14 experts in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, or preventive medicine, and one voting member representing consumer interests. There are also 30 non-voting representatives from professional organizations who provide comment and offer important perspectives during ACIP’s public meetings. ACIP members also participate in working groups which thoroughly review scientific information on vaccines and present findings and recommendations to the full ACIP, which votes on their recommendations.
Following the FDA’s authorization or approval of a COVID-19 vaccine, the ACIP convenes a public meeting as soon as possible to review all available clinical data. The recommendations formulated by ACIP outline which populations should receive a vaccine, including the ages of people who should receive the vaccine, the number of doses a person should receive, the appropriate amount of time between doses, and precautions and contraindications. Ultimately, the CDC director reviews and decides whether to approve or modify ACIP’s recommendations, which are then published in the CDC’s Morbidity and Mortality Weekly Report. Once published, the recommendations are codified as official CDC vaccine recommendations.
VRBPAC met today (Oct. 26) to determine whether the Pfizer vaccine should receive emergency use authorization for children ages 5 to 11. The committee heard a full day of presentations on the epidemiology of COVID-19 in children, safety data related to myocarditis risk in adolescents and children, a presentation from the vaccine’s manufacture Pfizer, and comments from the public. Ultimately, VRBPAC voted 17-0 to recommend the emergency use authorization to the FDA, with one member abstaining.
ACIP will meet Nov. 2”’3 to review all available clinical data regarding the use of the vaccine in children before making its final recommendation. The agenda for ACIP’s meeting is not yet available.