The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee has three major applications to review this month. The committee will have meetings on Oct. 14, Oct. 15 and Oct. 26.
Moderna and J&J officials are seeking Emergency Use Authorization to begin providing booster shots to those eligible. The Pfizer vaccine is the only one approved for booster shots.
First up will be Moderna on Oct. 14, followed by the presentation by J&J on Oct. 15.
“The available data makes clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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Dr. Jane Kelly, assistant state epidemiologist with the South Carolina Department of Health and Environmental Control, said, “Preliminary data I have seen looks good and I would anticipate both of those would be approved. For example, for the J&J second dose — and again, this is preliminary, unpublished data — but it looked like the vaccine effectiveness increased to 94%.”
On Oct. 8, Pfizer submitted its application to the FDA to seek EUA for its vaccine to be allowed on children aged 5 through 11. Pfizer is the only vaccine approved for aged 12 through 17.
Kelly said, “FDA will also be meeting later this month to talk about the Pfizer application for emergency use authorization for vaccines for ages five to 11. That’s something where the preliminary data looks excellent for safety and effectiveness in preventing infection.”
The FDA intends to livestream the VRBPAC meetings on the agency’s YouTube page.
The livestream will also be available on the agency’s Facebook and Twitter accounts and as a webcast on www.fda.gov
Dana Lynn McIntyre is a Staff Reporter with The Augusta Press. You can reach her at dana@theaugustapress.com
