FDA Says Suggestion To Halve Moderna Vaccine ‘Not Rooted’ In Available Science | Talking Points Memo

Most decision on dosing are based on animal trials - what worked in a mouse and then, perhaps, a monkey. The 21 day vs 28 boosts decisions are almost always a legacy of animal immunology. That is not a bad thing since our immune systems pretty much function the same way, but almost no one does a detailed study on when to administer the second dose, relying on past experience with similar vaccines, where available. Likewise with the dose. As a vaccinologist, I want to give as much antigen as the host can tolerate to maximize the chance of success. If a trial fails because I gave too little antigen, I have blown a lot of money and time. I may test lower doses in a future trial, but first I want to know what works. They will have included some lower doses in the phase 1 trial, but as you indicate there were likely not enough recipients of the lower dose to make the observation statistically significant. I still think the FDA is correct to require that the manufacturers stay with the approved regimen until they actually complete a lower dose trial.

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[quote=“ralph_vonholst, post:5, topic:202105”] [quoting kathrynvarn]
Lord have mercy.
[/quote]

I’d rather She not.