It’s not just good vaccine news here in the UK. Over in the States, the FDA has released its analysis of the Pfizer COVID-19 vaccine, and it’s a glowing report for the new drug experts hope will slow the spread of coronavirus. Pfizer, and its partner BioNTech, announced they were submitting their vaccine to the US Food and Drug Administration at the end of November, aiming for emergency use authorization (EUA) so that it could be publicly deployed.
As you’d expect, the FDA isn’t taking that process lightly. Pfizer and BioNTech had previously announced a 95-percent success rate in Phase 3 trials, with no serious safety concerns or side-effects observed.
However that was before the FDA weighed in on the data. In advance of a hearing this Thursday, in which the agency’s vaccine advisory board will give its recommendation for authorization or not, the official FDA documents have been released today. They detail the FDA’s opinions on BNT162b2, the COVID-19 vaccine candidate.
What’s up with the FDA’s Pfizer hearing?
As the U.K. started Covid-19 vaccinations across the country on Tuesday, this week could also mark an early turning point in the U.S. battle against the coronavirus.
An advisory panel made of up of top medical experts will help the Food and Drug Administration gain outside perspective in reviewing a shot by Pfizer and BioNTech 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 some key points to help clarify the approval process:
Why are they meeting?
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 in 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.
What’s the timeline?
On Tuesday, 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.
The briefing documents are also likely to include questions the FDA wants its advisers to answer as well as specific wording for any final vote. Typically, advisory committees vote at the end of a meeting to indicate whether they think the FDA should approve the product under review, but not always.