AAFP Approves Simplified COVID-19 Vaccine Recommendations
Details on Composition of New Vaccines Expected Soon
April 28, 2023, News Staff — The AAFP, following an expedited review, has officially approved actions by the FDA and CDC to streamline COVID-19 vaccine recommendations for infants, children and adults, and to allow people at increased risk of infection the option to receive an additional dose of bivalent COVID-19 vaccine.
The Academy has also updated its COVID-19 webpage to reflect the latest information.
The FDA amended the emergency use authorizations of the Moderna and Pfizer-BioNTech bivalent mRNA vaccines on April 18. Under the amended EUAs:
- Monovalent versions of the vaccines are no longer authorized for use in the United States.
- The current bivalent vaccines are authorized for use in individuals ages 6 months or older.
- Individuals 65 years and older who have already received a single dose of a bivalent vaccine may receive one additional dose at least four months after the initial dose.
- Most people with immunocompromising conditions who have already received a bivalent vaccine may receive one additional dose at least two months after their initial dose. Additional doses may be administered at the discretion of their healthcare professional.
- For immunocompromised infants and children ages 6 months through 4 years, eligibility for additional vaccine doses will depend on the type of vaccine previously received.
- Most unvaccinated individuals may receive a single dose of a bivalent vaccine.
- Unvaccinated infants and children may receive a three-dose series of the Pfizer-BioNTech bivalent vaccine (ages 6 months through 4 years) or a two-dose series of the Moderna bivalent vaccine (age 6 months through 5 years).
- Unvaccinated children who are 5 years old may receive two doses of the Moderna bivalent vaccine or a single dose of the Pfizer-BioNTech bivalent vaccine.
- Children ages 6 months through 5 years who have already received one, two or three doses of a monovalent COVID-19 vaccine may receive a bivalent vaccine, but the number they receive will depend on the vaccine and their vaccination history.
Story Highlights
The CDC on April 19 revised its interim clinical considerations for the use of COVID-19 vaccines to include recommendations that closely aligned with those of the FDA. Members of the agency’s Advisory Committee on Immunization Practices also met on April 19 and, while not casting an official vote, expressed support for the recommendations.
The executive committee of the Academy’s Commission on Health of the Public and Science reviewed the amended EUA and the revised interim clinical considerations, and submitted a recommendation of approval to the AAFP Board Chair. The Board Chair approved the recommendation on April 21.
The moves from the FDA and CDC are the latest in an ongoing federal effort to simplify the composition and administration of COVID-19 vaccines.
In January, the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend “harmonizing” the composition of COVID-19 primary vaccine doses and booster doses so all administered vaccines will consist of a bivalent dose.
In February, the CDC, along with the AAFP and and several other medical organizations, released the 2023 adult and childhood/adolescent immunization schedules, both of which recommend routine vaccination against COVID-19 for all individuals except where indicated.
The CDC’s COVID Data Tracker estimates that more than 104 million cases of COVID-19 have occurred in the United States since the start of the pandemic, resulting in more than 1.1 million deaths. For the week ending April 22, the Data Tracker indicates omicron subvariants are still the most prevalent variants of concern in the United States, with one subvariant (XBB 1.5) accounting for nearly 74% of cases.
According to the April 18 FDA release, the agency will discuss the strain composition of COVID-19 vaccines for fall 2023 at a VRBPAC meeting in June. The date and other details will be posted on the FDA Advisory Committee Calendar webpage.
The ACIP will hold its next meeting June 21-22, and is expected to discuss the fall COVID-19 vaccine schedule at that time.