The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the agency endorse administering Moderna Inc.'s COVID-19 vaccine, Spikevax (elasomeran), to adults. The vote was a strong echo of the FDA’s full approval of the vaccine for adults only a few days earlier, on Jan. 31. After hearing safety and efficacy data from Moderna and an internal analysis of that data from the CDC, ACIP recommended by a vote of 13-0 that the CDC endorse the vaccine’s use for people 18 years and older.
Within hours of a Jan. 5 vote on COVID-19 boosters for adolescents, U.S. CDC Director Rochelle Walensky endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all adolescents aged 12-17 years should receive a booster dose five months after their primary series. The recommendation applies to the Pfizer Inc.-Biontech SE COVID-19 vaccine, as it’s the only one authorized in the U.S. for use in adolescents.
Once the CDC accepts the recommendation of its Advisory Committee on Immunization Practices (ACIP), the COVID-19 vaccine regimen, at least for the Pfizer Inc.-Biontech SE vaccine, will include a booster dose for everyone 12 and older. ACIP voted 13-1 at a Jan. 5 emergency meeting to recommend the booster dose for 12- to 17-year-olds at least five months after a primary series of the Pfizer vaccine.
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
In a move that had been expected, the CDC’s Advisory Committee on Immunization Practices unanimously recommended the Pfizer Inc.-Biontech SE COVID-19 vaccine as safe and beneficial for children ages 5 through 11. The recommendation, coming from a 14-0 vote, is the committee’s way of reassuring the American public that the vaccine is safe, according to committee member Beth Bell, clinical professor in the School of Public Health at the University of Washington in Seattle.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits of Pfizer Inc.-Biontech SE pediatric formulation of its two-dose COVID-19 vaccine outweigh its risks for children ages 5 through 11. Many of those votes came with caveats, as the VRBPAC members struggled with the unknowns of the vaccine and the fear that schools would mandate its use, even though it would still be considered experimental if the FDA grants it an emergency use authorization.
Despite some concerns from a few members, the Advisory Committee on Immunization Practices unanimously approved recommendations to the CDC that boosters be made available to those wanting them. The advisory committee recommended that a single COVID-19 vaccine booster dose be given six months or more after completing an mRNA primary series in the same risk group for whom the CDC recommended a booster dose of Pfizer Inc-Biontech SA’s vaccine. The CDC presented data to the committee that the single mRNA COVID-19 vaccine dose be given to those age 65 and older, for those at least 18 years old and reside in long-term-care settings, and also for those ages 50 to 60 with certain underlying medical conditions.
Given the FDA’s Vaccines and Related Biological Products Advisory Committee’s unanimous vote last month to recommend use of a booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine in certain high-risk groups, it came as no surprise when the committee again voted unanimously Oct. 14 for a mirror use of Moderna Inc.’s proposed booster.
CDC director Rochelle Walensky’s early morning announcement on Sept. 24 recommending boosters for certain frontline workers was considered wise by some but as undermining her advisers and the process by others. She endorsed the Advisory Committee on Immunization Practices’ recommendation for booster doses of the Pfizer Inc.-Biontech SE COVID-19 vaccine but overruled one of the panel’s Sept. 23 decisions by adding boosters for people ages 18 to 64 who are at increased risk of COVID-19 exposure and transmission due to occupational or institutional setting, based on their individual benefits and risks.
Constrained by the U.S. FDA’s authorized conditions of use for a booster dose of Pfizer Inc. and Biontech SE’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled with making recommendations Sept. 23 for the use of the booster, with several members questioning the need for a third dose in some of the populations the FDA identified.
