Pfizer COVID-19 vaccine fully FDA-approved

Good news: the Pfizer/BioNTech COVID-19 vaccine is now fully FDA-approved!

Full FDA approval

Today came the very good news that the US FDA has granted full approval for the Pfizer/BioNTech COVID-19 vaccine! ^[1] So probably we should stop calling it “the Pfizer/BioNTech vaccine” and instead start using its names? Because everything medical in the US has to be complicated, it has two: the generic name is tozinameran, and the commercial copyrighted name owned by Pfizer is Comirnaty.

(Here at Chez Weekend, we also approve. Though there’s no reason for you to care about that.)

We had previously wondered what the long delay in approval was, since Pfizer had filed the application in May, and Moderna had done so in June. Apparently the answer is the required 6 months of follow-up safety data. Still, the trial started last summer, so it’s been a year. There’s something about why it took 12 months to get the 6 months of safety data that we obviously don’t understand.

Some interesting facts and possible consequences:

• Safety follow-up data for ages 12-15 is still being collected; the clinical trial for kids under 12 is still ongoing.
• The final word on vaccine efficacy against serious disease in the 44,000 person clinical trial comes in at 91.1%. That’s largely before Delta, though.
• 1.2 billion doses have been made so far, rising to about 3 billion by the end of this year.
• Pfizer frequently notes that they did not take Trump’s Operation Warp Speed money.
• Talk of a 3rd booster dose can now get serious, though I’d still like to see the booster be specific to the Delta strain.
• It may reduce vaccine “hesitancy” among the less lunatic fraction of the unvaccinated. We can start having intelligent conversations about vaccine mandates in schools, universities, workplaces, and so on.

Approved.

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Notes & References

1: H Branswell & A Joseph, “FDA grants full approval to Covid-19 vaccine developed by Pfizer, BioNTech”, STAT News, 2021-Aug-23. ↩