Astral Codex Ten

Pfizer

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Pfizer

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Pfizer is a recurring organization in the Astral Codex Ten archive, appearing 3 times across 3 issues between August 20, 2021 and November 23, 2021. The archive places it in contexts such as “people think about who interacts with the FDA, they often think about large biotech, like … Pfizer”; “Pfizer must then show that the commercial batches will be identical in every relevant way to the clinical trial batches”; “Pfizer/Merck will have thrown everything at this problem”. It most often appears alongside FDA, aducanumab, Andrew.

Metadata

  • Category: Organizations
  • Mention count: 3
  • Issue count: 3
  • First seen: August 20, 2021
  • Last seen: November 23, 2021

Appears In

Source Context

Recovered passages from the original issue text. When the raw archive preserved outbound links inside the source passage, they are listed directly under the quote.

Highlights From The Comments On Aducanumab
August 20, 2021 · Original source
I wanted to add a different voice to the mix: the voice of small biotech. When people think about who interacts with the FDA, they often think about large biotech, like Biogen and Pfizer. But, as with any industry, there are many more small players than there are large players. And, as with any industry, it is much more intimidating dealing with regulators as a small player than as a large player.
When Will The FDA Approve Paxlovid?
November 23, 2021 · Original source
For context: a recent study by Pfizer, the pharma company backing the drug, found Paxlovid decreased hospitalizations and deaths from COVID by a factor of ten, with no detectable side effects. It was so good that Pfizer, “in consultation with” the FDA, stopped the trial early because it would be unethical to continue denying Paxlovid to the control group. And on November 16, Pfizer officially submitted an approval request to the FDA, which the FDA is still considering.
Inline links: a recent study, submitted an approval request to the FDA
Perhaps that 10% chance of it not getting approved is very important, because that’s a world in which it’s discovered to have terrible side effects? But discovered how? There was one trial, it found no side effects at all, and Pfizer stopped it early. And it’s hard to imagine what rare side effect could turn up in poring over the trial data again and again that’s serious enough to mean we should reject a drug with a 90% COVID cure rate.
PS: Kudos to the Biden administration, which has already ordered 10 million courses of Paxlovid, effective immediately, to be distributed as soon as the FDA gives them permission. This is great. But all their initiative will go to waste unless the FDA can do its part quickly too.
Inline links: has already ordered
Highlights From The Comments On The FDA And Paxlovid
November 23, 2021 · Original source
To expand on this more: the clinical trials only show that *that one particular batch* was safe and efficacious (the FDA thinks this, since they agreed to terminate the trial early). Pfizer must then show that the commercial batches will be identical in every relevant way to the clinical trial batches, so that they will have the same safety and efficacy. What are the relevant ways? Pfizer must decide that, and justify their decisions to the FDA with supporting evidence.
Pfizer/Merck will have thrown everything at this problem alongside the clinical trials, as they can afford to do this, so their regulatory submissions will be pretty good. However they still might have to store the new batches for a few months to demonstrate that they have a comparable shelf-life to the old batches, and FDA might wait to see this data etc.
Note that this really only applies to new chemical entities; people have been manufacturing fluvoxamine for years and its probably well understood by now. Not always true though; we saw a worst-case situation recently with the ranitidine withdrawal: a medicine that some reasonably healthy people take every day of their lives was shown to be contaminated with small amounts of a nasty carcinogen. If Pfizer happened to have some gaps in their understanding for the Paxlovid process, the FDA might go easy on them as dying of Covid now is worse than a slightly increased risk of cancer in the future, but it takes time to review all of these risks and make a justified decision.