Based on the FDA advanced posting of material regarding the advisory committee meeting tomorrow to consider an EUA for the Pfizer vaccine, it appears that there should be clear sailing. From the materials that I was able to review, there were very few serious adverse reactions, 95% efficacy rate, and low episodes of severe disease in patients receiving the vaccine that contracted the virus.
A headline in the San Diego Union Tribune this morning reads: S.D. Scientists: FDA’s Pfizer Report “Bodes Well”. The materials posted on the FDA website in advance of the meeting can be found here. With the successful rollout of the Pfizer vaccine in Europe over the last two days, there did not seem to be any other unusual incidents, with the exception of a few reports of allergic reactions (here).
With the EUA evaluation in progress at the Agency, the expert advisory committee meeting tomorrow, expectations appear high that a positive result will occur. This could be the beginning of turning the corner on the pandemic. Of course, long term safety data will not be available for months, and something can always go wrong; however, all data points to a potential home run. Let us see how the advisory committee votes and then how fast the FDA moves. The next advisory committee meeting is scheduled for December 17, 2020, to review the EUA for the Moderna vaccine candidate. Both products are messenger RNA based and the general view is that both have approximately the same efficacy and safety profile, so if the Pfizer meeting goes well, then it is reasonable to expect the same result on the 17th!
