FDA was always OK with crummy efficacy. The guidelines (these are the revised ones, but the original ones were the same in this respect: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19) said 50% efficacy, with a wide enough confidence interval that 30% efficac…
There is, of course, the issue of quality and potency validation. No one has ever talked about how many copies of mRNA are supposed to be in each dose. It's always phrased in terms of micrograms (and I recall one FDA email saying "milligrams" instead of "micrograms" ... I guess you really don't need to know anything to work there).
It's like the mercury in the old multi-dose shots and the shaking-the-OJ metaphor. Who gets a bit more than the others? How can we control for that? Is anybody checking? But in this case, there's not even a pretense that we know. I have not seen anywhere how many copies of mRNA are *supposed to be* in each dose (for any age group, for either vendor). So how are these manufacturers complying with B.2.e. on page 11 of the linked document?
And then there's the FDA's pesky (non-binding, of course) request for biodistribution studies (C.2.a. on page 13). I've seen the Japanese one and the English translation, as well as reading a bit of commentary from Dr. Byram Bridle on both versions. I don't know... Is saturating a kid's (or even an adult's) ovaries with lipid nanoparticles encapsulating spike-protein-generation-inducing mRNA a good plan? Does FDA plan to concern itself with this, or will they just let Sara Oliver and Keipp Talbot BS us in their creepy evil-Barbie voices?
So: You're right, Toby, once again. And in even more ways than you might have noticed.
FDA was always OK with crummy efficacy. The guidelines (these are the revised ones, but the original ones were the same in this respect: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19) said 50% efficacy, with a wide enough confidence interval that 30% efficacy would be OK. I kid you not (p. 13 of 31).
There is, of course, the issue of quality and potency validation. No one has ever talked about how many copies of mRNA are supposed to be in each dose. It's always phrased in terms of micrograms (and I recall one FDA email saying "milligrams" instead of "micrograms" ... I guess you really don't need to know anything to work there).
It's like the mercury in the old multi-dose shots and the shaking-the-OJ metaphor. Who gets a bit more than the others? How can we control for that? Is anybody checking? But in this case, there's not even a pretense that we know. I have not seen anywhere how many copies of mRNA are *supposed to be* in each dose (for any age group, for either vendor). So how are these manufacturers complying with B.2.e. on page 11 of the linked document?
And then there's the FDA's pesky (non-binding, of course) request for biodistribution studies (C.2.a. on page 13). I've seen the Japanese one and the English translation, as well as reading a bit of commentary from Dr. Byram Bridle on both versions. I don't know... Is saturating a kid's (or even an adult's) ovaries with lipid nanoparticles encapsulating spike-protein-generation-inducing mRNA a good plan? Does FDA plan to concern itself with this, or will they just let Sara Oliver and Keipp Talbot BS us in their creepy evil-Barbie voices?
So: You're right, Toby, once again. And in even more ways than you might have noticed.
Great details! Thank you!!! 🙌