WASHINGTON — The coming week could mark an early turning point in the U.S. battle against COVID-19. Advisers to the Food and Drug Administration are set to review the first vaccine and their …
By Anna Edney| Bloomberg News WASHINGTON — The coming week could mark an early turning point in the U.S. battle against COVID-19. Advisers to the Food and Drug Administration are set to review the first vaccine and their guidance could speed authorization, clearing the way to making it a top weapon against the virus. An advisory panel made of top medical experts will help the agency gain outside perspective in reviewing an experimental shot from Pfizer Inc. and its German partner BioNTech SE before any final ruling is made on whether its use can be authorized on an emergency basis. The meeting is set for Thursday. Here are five key points to help clarify the approval process: Queston: Why are they meeting? Answer: FDA Commissioner Stephen Hahn pledged earlier this year to hold public advisory committee meetings for each COVID-19 vaccine that seeks emergency authorization. That vow came after trust in the agency, as well as any vaccine that might be made available, waned following President Donald Trump’s push for a vaccine to be approved ahead of the presidential election in early November. Q: What’s the timeline? A: Two days before the panel meets in what is expected to be a lengthy session, the advisers and the public will get their first hint of the agency’s view of the clinical trial data with the release of extensive briefing documents and comments from the FDA staff.
