[dragonwriter]

> If the FDA is not able to deliver our documents to us in time, maybe it is time to shut it down. Let

More sensibly, if we want the FDA to make delivering a particular set of documents a sizable piece of its job, we should (through Congress) direct that and allocate appropriate funding for that purpose.

[daddylongstroke]

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]

Yeah, 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.