Thursday, September 16, 2021
The U.S. Food and Drug Administration hearing on Friday, September 17, 2021 to address the question of approval for "booster" doses of Covid-19 vaccines is scheduled to be "open" to the public through online portals. The hearing begins at 8:30 a.m. Eastern time.
The FDA's website helpfully links to the submissions from the drug companies and other interested parties as well to the hearing portal. In contrast to The Lancet article published earlier this week which takes the position that a booster vaccine dose is not "currently" indicated for most members of the public, Pfizer and Moderna each submitted materials to the FDA this week in support of administering third shots beginning six months after an individual's second shot. Pfizer is recommending a full-strength dose for its booster shot, while Moderna is recommending a dose that is 1/3 the level of its original doses. It appears both companies are citing observational studies, clinical trials, and antibody tests in support of their recommendations, including studies in the U.S., Israel, and South Africa, and discuss histories of reactogenicity, adverse events, and risk/benefit assessments.
Here's the useful FDA vaccine hearing webpage and links: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-september-17-2021-meeting-announcement#event-materials