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So I guess while we're all waiting around for FDA's vaccine authorization notice, a few things that I'll be looking for in the notice:
- Which populations are covered under the indication? (Likely persons 16 y/o+)
- Which populations aren't? (Young children, pregnant persons?)
- Which populations are covered under the indication? (Likely persons 16 y/o+)
- Which populations aren't? (Young children, pregnant persons?)
- Are there any noted side effects or warnings, like for Bells Palsy, Anaphylaxis or Appendicitis?
- Does FDA's label comport with the label of Health Canada or the UK's MHRA?
- What's the vaccine called? BNT162b2, or the Pfizer-BNT COVID-19 Vaccine?
- Does FDA's label comport with the label of Health Canada or the UK's MHRA?
- What's the vaccine called? BNT162b2, or the Pfizer-BNT COVID-19 Vaccine?
- What does the final monitoring plan for the vaccine look like? (Used to answer outstanding questions related to safety, efficacy or additional data)
- Are there any special requirements for administration? (FDA suggested an epinephrine injector on hand to address any reactions)
- Are there any special requirements for administration? (FDA suggested an epinephrine injector on hand to address any reactions)
- How does the FDA characterize this authorization in its press statement? Which people are quoted? (Definitely Hahn, but does Azar make an appearance?)
There will obviously be more things to notice once we see the product label and announcement, but if you can answer those questions, you'll be in great shape.
And one last yell for the people in the back....
IT'S AUTHORIZATION, NOT APPROVAL.
IT'S AUTHORIZATION, NOT APPROVAL.
