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UPDATE: We've been clamoring to see the vaccine data for months. That will finally happen on Tuesday (December 8), when Pfizer’s info is released to the public. Here are some things I’ll be looking for that were not revealed in press releases: 1/
1. What do we know about the memory T cells of vaccinated volunteers? There’s been a shift in thinking on the role of these immune cells. They may be more important for protection than neutralizing antibodies, which have previously been the focus. 2/
2. Most major adverse events appear within 6-8 weeks of vaccination. (Minor events have a different timeline). After tens of thousands of vaccinations, there does not appear to be a common, severe side effect associated with this vaccine. What about uncommon events? 3/
Why this matters: The first rotavirus vaccine was associated with a rare, severe event: intussusception (bowel blockage). It wasn't statistically significant & the vaccine was approved. Soon after, blockage became more common and the vaccine was withdrawn. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3460207/
So, back to COVID: Are there rare side effects associated with mRNA vaccines we should be aware of? And should those events impact whom we choose to initially vaccinate? Note: These vaccines do not, as some suggest, alter your genetic code. (They don't enter the nucleus).
3. Symptomatic disease looks to be less common in Pfizer’s study than in the general population, even in the placebo group. (Perhaps volunteers are the type to wear masks & social distance). Are there details about volunteers that could limit the generalizability of the data?
4. What happens after one dose of the vaccine? (Pfizer requires two). What happens if the second dose is given later than intended? How much leeway do we have? The real world is messy, and soon we'll be fielding these questions.
Takeaway: I expect the advisory committee to recommend emergency authorization with the caveat that people should consider individual risks and benefits before taking the vaccine. Many will then turn to their doctors for guidance. (I hope?).
Soon, we'll know what to tell them.
Soon, we'll know what to tell them.
