AAFP Approves Updated COVID-19 Vaccine Plan From FDA, CDC
Agencies Greenlight Two More Boosters, Mix-and-Match Strategy
October 25, 2021, 2:19 p.m. Michael Devitt — On Oct. 21, CDC Director Rochelle Walensky, M.D., endorsed a pair of recommendations from the agency’s Advisory Committee on Immunization Practices for the use of single vaccine booster doses of COVID-19 mRNA vaccines in adults at least six months after completion of the initial vaccination series, and for the use of a single COVID-19 vaccine booster dose of the Janssen/Johnson & Johnson vaccine in adults at least two months after the initial dose.
The AAFP approved the advisory committee’s recommendations following an expedited review of the evidence, and has updated its COVID-19 Booster Doses FAQs webpage to reflect the latest information.
The ACIP’s vote, Walensky’s endorsement and the AAFP’s approval all occurred shortly after the FDA took a series of steps to expand the use of COVID-19 vaccine booster doses for tens of millions of American adults. On Oct. 20, the agency amended its existing emergency use authorizations for the Moderna and Janssen/Johnson & Johnson COVID-19 vaccines to allow the use of single booster doses in a variety of people and situations.
The FDA’s actions have the following effects:
- Individuals age 18 and older may now receive a single booster dose of the Janssen/Johnson & Johnson vaccine at least two months after receiving the original single dose.
- Any adult 65 and older, or any adult age 18 to 64 who is at high risk of severe COVID-19 illness or complications due to underlying medical conditions or frequent exposure to SARS-CoV-2, may now receive a single booster dose of the Moderna vaccine. The Moderna single booster comprises half of the dose given for a dose in the primary vaccination series, and is administered at least six months after the second shot of the two-dose Moderna regimen.
- Eligible individuals who completed their primary vaccination with one COVID-19 vaccine may now receive a booster dose of a different vaccine — a heterologous, or “mix-and-match,” strategy that will make it easier for people who may have difficulty obtaining a booster dose of the same vaccine, or who may have concerns about potential side effects from or reactions to a particular vaccine.
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The FDA also reiterated that a single booster dose of the Pfizer-BioNTech vaccine may be administered to adults who experience frequent exposure to SARS-CoV-2. The FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine in September to allow for use of a single booster dose for certain populations. The booster dose may be given at least six months after completion of the primary vaccination series.
Booster doses will be important to provide additional protection to individuals at increased risk of severe COVID-19. While the primary series of the COVID-19 vaccines remain effective at preventing hospitalization and death from COVID-19, there may be some decline in immunity over time. This is true for many vaccines, with booster doses commonly included in vaccine recommendations. The goal of vaccines is to prevent serious disease and death from infectious diseases by coaching the immune system to respond effectively following infection.
According to the CDC’s COVID Data Tracker, more than 733,000 Americans have died from COVID-19. As of Oct. 24, more than 66% of the U.S. population has received at least one dose of a COVID-19 vaccine, and just over 57% are considered fully vaccinated. The AAFP continues to strongly urge all individuals who are eligible and have not been vaccinated against COVID-19 to do so as soon as possible. Vaccination, along with other risk mitigation tools such as masks and social distancing, are the most effective strategies for ending the pandemic.
Decisions on COVID-19 Vaccines for Children Coming Soon
In related news, the FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to meet Oct. 26 to review an EUA request from Pfizer Inc. to expand use of its COVID-19 vaccine to include children ages 5 to 11.
The ACIP, meanwhile, is scheduled to meet Nov. 2-3 to discuss COVID-19 vaccines for children, and is widely expected to review and vote on Pfizer’s prospective EUA.
Shipments of pediatric COVID-19 vaccines may begin as soon the FDA grants an EUA, and administration of the vaccines may begin once the ACIP and Walensky make a recommendation in support of their use. The AAFP has provided information on vaccines for children and adolescents along with resources from the CDC to aid family physicians in preparing to provide vaccines for these younger age groups.
More From AAFP
Staff experts at the Academy are continually updating resources and content on AAFP.org and familydoctor.org to keep members apprised of the latest information. The Academy’s COVID-19 and COVID-19 Vaccine webpages contain the latest data on the pandemic and the vaccines used to fight COVID-19, along with information on recent and upcoming FDA and ACIP meetings, educational materials for clinicians and patients, advocacy and more.