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
An epidemiologist at the CDC (Adam MacNeil) updated us on three variants circulating in the U.S.: B.1.1.7 (UK); B.135.1 (South Africa); and P.1 (Brazil). But, if you’ve been following my newsletter, he didn’t present anything we didn’t already know.
Variants are widespread
B.135.1 and P.1 are worrisome because they can overcome immunity, like seen in Zambia and Manaus
To have 95% chance of identifying a variant that occurs in 1 out of 1000 cases (0.1% prevalence), need ~3,000 sequences per week. It seems like the U.S. is meeting this metric
We are on track for B.1.1.7 to be dominant on March 23. It will hit Florida on March 8 and California on April 5
He also said: “The U.S. is nowhere close to having herd immunity”
The CDC (Tom Shimabukuro) gave us a report on people who received a vaccine while pregnant. He provided data from two of our vaccine reporting systems:
V-safe: There are 1,815 people in the pregnancy registry so far. There are no concerning safety signals from V-safe
Vaccine Adverse Event Reporting System (VAERS): 154 adverse events were reported by pregnant people and 73% of them were not pregnancy related (headache, fatigue, chills and pain at the injection site). These rates of adverse events were the same as in the clinical trials with non-pregnant people. There were 29 miscarriages reported, but this is reflective of the rate among the general population, so he isn’t worried.
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.