The FDA announced that it has set key meetings for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.
On Oct. 14 and 15, the advisory committee will meet to discuss the use of booster doses of the Moderna COVID-19 vaccine and the Janssen COVID-19 vaccine, respectively. During the Oct. 15th meeting, the committee will also hear presentations from the National Institute of Allergy and Infectious Diseases on the use of a booster of a different vaccine than the one used for the primary series — aka a “mix and match” booster.
During the meeting, the committee will hear presentations from the companies on the data for their respective vaccines. The FDA will also present its own analyses of each of the manufacturers’ data.
Additionally, the FDA is also convening an advisory panel on Oct. 26 to discuss whether to authorize Pfizer's vaccine for children ages 5 to 11.
In late September, Pfizer and BioNTech announced promising results from their highly anticipated phase 2/3 trial studying the effectiveness and safety of their COVID-19 vaccine for children ages 5 to 11. The antibody responses in the 2,268 participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16-25 years of age immunized with 30 µg doses. The vaccine was shown to be safe and well tolerated, according to the partners.
The FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page (Oct. 14 meeting link; Oct. 15 meeting link; Oct. 26 meeting link), which will be viewable on the agency’s Facebook and Twitter channels.