glawgii OP t1_j10gr2h wrote
Interpretation:
>This early warning system is the first to identify temporal associations
for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the
elderly. Because an early warning system does not prove that the
vaccines cause these outcomes, more robust epidemiologic studies with
adjustment for confounding, including age and nursing home residency,
are underway to further evaluate these signals. FDA strongly believes
the potential benefits of COVID-19 vaccination outweigh the potential
risks of COVID-19 infection.
SerialStateLineXer t1_j13cf9i wrote
The patients receiving the Pfizer vaccine were older, sicker, and more likely to be in nursing homes. The RR fell to 1.15 for pulmonary embolism and 1.26 for immune thrombocytopenia after controlling for this. The baseline rates were on the order of 0.06% and 0.01%, respectively, so even assuming that this is a real effect and not just a result of inadequate controls, this is roughly equivalent to an increase in absolute risk of 0.01% for PE and 0.003% for IT (doing very rough math in my head).
Skreame t1_j11qia2 wrote
The last statement about what the FDA believes can be substantiated by the fact that whatever risk and association the vaccine has to something like PE, covid’s values are magnitudes more, right?
JohnFByers t1_j12ecjn wrote
In other words, yes. The agency supports vaccination because of the benefits outweighing the risks.
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