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.
When the White House COVID-19 Response Team announced its booster program in August, it justified the broad use of a third vaccine dose with antibody studies and real-world data from Israel.
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.
The CDC’s Advisory Committee on Immunization Practices (ACIP) deliberated the matter of third COVID-19 shots, with panel members voting whether to recommend “additional doses of mRNA COVID-19 vaccines as part of a primary [two-shot] series” in certain immunocompromised patients. A work group set up by ACIP decided previously that the desirable consequences outweighed undesirable ones in such a population.
Although the U.S. CDC considers myocarditis to be a rare event linked to mRNA COVID-19 vaccines, the FDA is adding a warning about the adverse event to its doctor and patient fact sheets for the vaccines.
It came as no surprise May 12 that the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 14-0, with one recusal, to recommend the use of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), in 12- to 15-year-olds following the FDA’s decision earlier this week to expand the vaccine’s emergency use authorization (EUA) to that age group.
The CDC’s Advisory Committee on Immunization Practices again took up the matter of risk vs. benefit with the COVID-19 vaccine made by Johnson & Johnson, and proved significantly less skeptical at its second meeting. The FDA and CDC swiftly determined that the recommended pause should be lifted and use of the vaccine should resume.
The FDA reported a new streamlined pathway for diagnostic testing as part of a serial testing program using pooled samples, a pathway that should enable the further reopening of the economy. However, the FDA’s Tim Stenzel said April 21 that this new pathway relied on accumulated data for molecular testing, and that the agency lacks sufficient data to provide a similar mechanism for this use of antigen tests.
The FDA has its hands full with the impact of the mutations to the SARS-CoV-2 virus, but test developers can count on an ever-increasing base of data for those viruses thanks to a new contract taken by the CDC. The CDC indicated recently that its sequencing efforts and that of other organizations churned out nearly 14,000 sequences for the week of April 3, but Aegis Sciences Corp., of Nashville, Tenn., announced April 7 that it had undertaken an agreement to perform next-generation sequencing of samples from all 50 states and Puerto Rico, ensuring plenty of access to up-to-date information on those mutations.
