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I believe the FDA is already mandated by law to release this data, which is why the original lawsuit was filed. From a Reuters article on it: They also argue t
by daddylongstroke 5y ago
I believe the FDA is already mandated by law to release this data, which is why the original lawsuit was filed.
From a Reuters article on it:
They also argue that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine."
So it really sounds like this is just part of the course of making sausage of approval. You have someone already embedded in the licensure project/process where this is all (very likely largely automagically) handled as it is always expected to be released to the public.
- Uberphallus 5y agoYeah, but this scale of documentation production is unprecedented. A lot of cash was dumped into fast and extensive R&D, trials and production scaling because of the urgency of the situation, and along comes an insane documentation backlog. To put in perspective, the original HPV vaccine R&D and trial spanned over 7 years with 25,000 patients (of which only 20,000 women), and assuming the documentation was provided to the FDA as it was produced, it could be FOIA'd relatively quickly. Pfizer/BioNTech did the same, with almost double the patients, in just over 6 months.