her notes on yesterday's VRBPAC meeting:
A consequential meeting took place at the FDA today.
yourlocalepidemiologist.substack.com
A very information-dense, but short article. Picked up a few things I didn't know:
- I wasn't aware that newborns were quite as susceptible to COVID hospitalizations as they apparently are (roughly the same as the age 65-74 cohort). I had thought that generally, when anyone very young got COVID, they skated right on through it (as is typically the case for RSV, though it can scare the bejeebuz out of parents!).
- That pharma companies could (and should) be doing more to test the immunity boosts of their vaccines. Dr. Jetelina writes:
A common theme throughout the pandemic FDA meetings is that “it’s too hard to measure anything other than antibodies” and “we don’t have the data needed to make a decision.” The FDA could require sponsors to do detailed investigations, e.g. assessing lymph nodes, bone marrow, and breakthroughs. This would help us understand immunity better, so we can make better recommendations.
- That there's really no more debate in the vaccine-research community about the value of the bivalent vaccine. Dr. Jetelina does lay out the devil's advocate position first, and then:
There is a problem with [bivalent vaccine] data though: people who got the bivalent vaccine are likely very different, in environment and behaviors (like masking), from people who didn’t get the bivalent vaccine. So, we don’t know if this difference in outcomes results from the vaccine, per se.
Moderna surprised us today with new data, though: a randomized trial in the U.K. They randomly gave people the original vaccine or the bivalent vaccine (BA.1 formula) as a booster. The bivalent vaccine did better. This really put the debate to rest.
- I was surprised she expressed hope that dang-near "magic" vaccines can be developed:
There are clearly limitations to the vaccines. We can do better. An NIH presenter said they are focusing on new vaccines that are
- Variant proof;
- Longer lasting; and/or
- Have enhanced ability to block infection/transmission.
This will take time, though, without an Operation Warp Speed 2.0-level investment or global collaboration. In addition, unlike the first generation mRNA vaccines, we don’t have decades of groundwork. We are really starting from scratch, and it will take time to understand what works and why.
One thing I do disagree with Dr. Jetelina about is that she believes that seasonal COVID patterns are not yet apparent:
The FDA thinks it’s already seeing seasonal patterns. (I disagree, although we agree this will eventually happen.)
Going by confirmed case counts, there have been both distinct winter peaks AND late summer/early fall peaks. This winter's peak, sadly, seems to be manifesting as as a rise in COVID deaths** more than as a sharp rise in confirmed case counts (which have risen, but mildly).
**
7-day average deaths of 286 on 11/29/2022 and 553 on 1/13/2023. Death numbers are being reported about 2 weeks in arrears, so at present the rise in deaths is still ongoing and has not shown signs of peaking.