The agency typically follows the recommendations of its advisory panels but is not required to do so.
“The good news is that this very important part of the process is playing out just like it should and just like it does with every other FDA regulatory review process,” said Dr Helen Boucher, Chief of Infectious Diseases at Tufts Medical Centre, in an interview with Reuters.
Data from the trial showed that the vaccine began conferring some protection to recipients even before they received the second shot. The agency’s staff noted that more data would be needed to assess the potential of a single-dose shot.
A two-dose vaccination was highly effective in preventing confirmed cases of COVID-19 at least seven days after the last dose, FDA staff said.
The experts will discuss whether it was reasonable to believe that the shot may be effective in preventing COVID-19, the briefing documents showed.
The documents were released on the day Britons began getting the Pfizer/BioNTech vaccine, the world’s first recipients outside of clinical trials.
The FDA staff said there was currently insufficient data to make conclusions about the safety of the vaccine in those less than 16 years of age, pregnant women and those whose immune systems were compromised.
There were a total of six deaths in Pfizer’s late-stage trial of the vaccine, with two deaths among patients receiving the vaccine and the rest in those on a placebo, the documents showed. All deaths represent events that occur in the general population at a similar rate, FDA staff said.
The FDA is expected to decide on whether to authorise the vaccine within days or weeks.
Pfizer shares rose nearly 1 per cent to $US41.66 ($56.22) before the bell. BioNTech’s US shares were up 1.3 per cent at $US127.10.
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