> The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.

I don't post this to spread doubt about the EUA and am fully confident in the safety and efficacy of these vaccines. But as written, this website would seem to suggest that the only difference is when production happens - which is not accurate.

[0] https://www.fda.gov/consumers/consumer-updates/understanding...

I think the major talking point is covered by this info, which is meant for the general public. I'll make an assumption that the general public is also less educated on average than the users on HN on average. A flowchart that would satisfy a bunch of nerdy engineers (us HN users) with all possible paths would confuse the heck out of everyone else.

https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-c...

Claims can only go by "vaccine court" (yes that's a thing according to Wikipedia)...

https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compen...

For the "vaccine court" you're just presenting a claim that vaccine X could cause condition Y, that you developed condition Y after taking vaccine X, and that there's no other reason you'd suffer from condition Y. If the court finds it plausible, you (and your lawyers) get paid, and everyone goes about their business the same as before.

> "NCLA is pleased that GMU granted Professor Zywicki’s medical exemption, which we believe it only did because he filed this lawsuit. According to GMU, with the medical exemption, Prof. Zywicki may continue serving the GMU community, as he has for more than two decades, without receiving a medically unnecessary vaccine and without undue burden. Nevertheless, NCLA remains dismayed by GMU’s refusal—along with many other public and private universities and other employers—to recognize that the science establishes beyond any doubt that natural immunity is as robust or more so than vaccine immunity.”

https://www.federalregister.gov/documents/2020/03/17/2020-05...

The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities. These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.”

...

The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.

Edit: also why is there such a large lag between EUA and full FDA approval? That flow chart seems misleading.

The EUA rules for each category is different in how they differ from the categories baseline. For vaccines the gulf between EUA and full process was relatively small - the clinical dataset was basically equivalent.

I found this article to be a better summary of the differences between EUA and BLA (https://blog.petrieflom.law.harvard.edu/2021/06/15/whats-the...). I think you are right - the diagram from the OP is somewhat misleading.

There is absolutely nothing stopping a company from manufacturing whatever they want before they get a BLA - they just can't market it.

In real terms, it looks like the two big time savers was reducing long-term effects follow up from 6 months to 2 months, and well as probably an abbreviated review of manufacturing processes.

That's plausible. Thanks!

Said another way, what was the extra steps that needed to happen between EUA & full approval?