Mon 2022-Jan-31

Moderna COVID-19 vaccine fully FDA-approved

Tagged: COVID / PharmaAndBiotech / Politics

Good news: the Moderna COVID-19 vaccine, aka ‘Spikevax’, is now fully FDA-approved!

Full FDA approval

Last August, we noted our Full Weekend Approval of the full FDA approval of Pfizer/BioNTech’s COVID-19 vaccine, which we are apparently supposed to call comirnaty/tozinameran.

Bransewell @ STAT News: FDA grants full approval for Moderna COVID-19 vaccine US FDA: Moderna Spikevax full approval and info sheets Today came the very welcome news that the US FDA has granted full approval for the BLA of the Moderna COVID-19 vaccine! [1] [2]

So probably we should stop calling it “the Moderna vaccine” and instead start using its names? Because everything medical in the US has to be complicated, it has two: the generic name is elasomeran, and the commercial copyrighted name owned by Moderna is simply marvelous: Spikevax!

(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 for Pfizer, and even more for Moderna, for no discerible reason. Still, the trial started last summer, so it’s been a year and a half. There’s something about why it took 12 months to get the 6 months of safety data that we obviously don’t understand. Especially why it took 6 months longer for Moderna; perhaps Pfizer, being a big pharma company, just knows better how to massage the FDA?

Incidentally, this is the very first approval for a Moderna drug. (And I can say “drug” now, not “compound”, or “candidate”, or … And it frees up a lot of insurance bureaucracy around reimbursement.)

Some interesting facts and possible consequences:

  • Moderna still hasn’t been approved for people under 18 years of age. They applied for approval last June, but the FDA told them to take a deeper look at myocarditis and pericarditis risks.
  • Moderna is delaying their filing for ages 6 - 11, pending the FDA evaluation of the myocarditis results in ages 12 - 18.
  • Given that a good fraction of the 10 billion COVID-19 vaccine doses given are Moderna, can we reduce vaccine “hesitancy” among the less lunatic fraction of the unvaccinated? We can start having intelligent conversations about vaccine mandates, of approved vaccines, in schools, universities, workplaces, and so on.

‘Approved’. That’s a good word, isn’t it?

Addendum 2022-Feb-05: CDC also approves

In an interesting display of speed, just 4 days later Reuters reports that the CDC’s Advisory Committee on Immunization Policy (ACIP) met and also voted full approval for Spikevax in clinical use for individuals over age 18. [3] The details and slide presentations to the ACIP are public, and somewhat interesting reading. [4]

So now we have 2 mRNA vaccines (Pfizer’s comirnaty and Moderna’s spikevax) that are (a) stupendously effective, (b) massively safe, (c) have been dosed in billions of people, (d) are fully FDA approved, and (e) fully CDC recommended for practitioners.

If you haven’t yet been vaccinated: this is your signal that everything has been done to prove that these are some of the safest and most effective medicines in human history. Don’t you think it’s time you get yourself some of that?


Notes & References

1: H Branswell, “And then there were 2: FDA gives full approval to Moderna’s Covid-19 vaccine”, STAT News, 2022-Jan-31.

2: US FDA Staff, “Spikevax and Moderna COVID-19 Vaccine”, US Food & Drug Administration, retrieved 2022-Jan-31. Kudos to Moderna for getting the FDA to say “Spikevax” repeatedly. :-)

3: Reuters Staff, “U.S. CDC backs full approval of Moderna’s COVID-19 vaccine”, Reuters, 2022-Feb-04.

4: US Centers for Disease Control & Prevention, “ACIP Presentation Slides: February 4, 2022 Meeting”, CDC Advisory Committee on Immunization Policy meeting materials, 2022-Feb-04.

Written Mon 2022-Jan-31

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