The FDA’s outside committee of experts, the VRBPAC, is meeting again today, one week after they voted to authorize the Pfizer / BioNTech vaccine. Pretty much everyone expects that the committee will give the nod to Moderna’s candidate this afternoon.
One factor easing Moderna’s path to a positive outcome, as compared to Pfizer: the former company is asking for leave to vaccinate people 18 years of age and older. Pfizer’s request to vaccinate ages 16 and up, backed by thin data, caused a few committee members to vote no last week.
The idea of using a “crossover” technique, to vaccinate people in the placebo arm of the Phase III study without unblinding it, will come up again. Last week Pfizer rebuffed the proposal. This will be one to watch.
The meeting starts at 9:00 am Eastern time (8:00 am Central). Here is the meeting’s draft agenda. I will be following the proceedings, not via the live video stream, but rather by courtesy of Stat News, whose reporters will be live blogging the meeting.
[ Note added 2020-12-17, 16:15 CST: ] The committee voted to recommend that the FDA authorize Moderna’s mRNA vaccine. The vote was 20 to 0 with one abstension.