Today's FDA meeting: Half time report

Right now external committee is meeting to vote on whether or not to recommend emergency authorization of the J&J vaccine to the FDA. Apparently the sexiness of an FDA meeting has weaned because very few people are watching compared to the Pfizer or Moderna meetings (1,900 people today vs. 15,000 people for Moderna/Pfizer).

This morning there were three “buckets” of discussion (2 of which had nothing to do with the vaccine but are important). Here are your cliff notes…

Update on Variants in the United States

Pregnancy Data

J&J vaccine

  • As per usual, the sponsor (J&J) presented their results and argument for emergency authorization. This was a bit boring, because nothing surprising came up. It’s safe and effective. Period.

The second half of the day will compromise of debate and a vote. It will pass. But I’m very curious to see if the J&J vaccine will be authorized for those aged 75+ years because there was very little data among this group in the clinical trial. There should also be a discussion about unblinding.

Love, YLE