FDA Panel Meeting to Discuss Covid Vaccine Boosters
No vote will be taken on any products at this meeting, the FDA said, and there will not be any discussion of any product-specific applications. The intent, it added, is for the experts to inform the agency on developing a general framework that will inform its regulatory decision-making.
The public will receive background information on the discussion two business days prior to the meeting
Questions under consideration will be whether the composition of existing vaccines needs to be updated to address specific variants and, if yes, what the timing and populations receiving booster doses should be.
The FDA said it will make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the session, and the event will be livestreamed on the agency’s website and YouTube channel.
“As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Now is the time to discuss the need for future boosters as we aim to move forward safely, with Covid-19 becoming a virus like others such as influenza that we prepare for, protect against, and treat.“
Report confirms efficacy of mRNA vaccine
A report on vaccine efficacy published this week by the CDC found the Pfizer and Moderna mRNA vaccines to be effective at preventing hospitalization and death from the Covid omicron, variat but not as effective in preventing mild disease. Those who received a third dose weathered the disease best.
According to the CDC, two doses of the vaccines were seen as 79% effective at preventing death and serious illness or patients requiring ventilators during the recent US omicron surge, while those who received booster shot had 94% protection.
The study was based on Covid cases at 21 hospitals in 18 US states from Mar. 11, 2021 to Jan. 24 2022, and the infectious diseases agency said it provided insight into how the vaccines worked against the alpha (original). delta and omicron variants
Moderna now also seeking EUA for fourth dose
Meanwhile, both manufacturers of mRNA Covid vaccines, first Pfizer/BioNTech and now Moderna, have asked the FDA for Emergency Use Authorization (EUA) for a second booster shot. When the American/German vaccine partners made their announcement last week, Moderna was still on the fence.
While Pfizer is seeking approval for a booster in the over-65 age group, Moderna’s application is for 18 and older.
The submission of Pfizer/BioNTech justifying the need for a fourth dose leans heavily on trials and real life information from Israel. In Germany, the health advisory panel of Robert Koch Institute has come out in favor of boosters for those over 60. Japan is also close to authorizing a fourth dose. Reports say the rollout could begin in early summer.
Author: Dede Williams, Freelance Journalist