FDA Approves First Covid-19 Vaccine

Re:FDA Approves First Covid-19 Vaccine by vlovich123 on Monday August 23, 2021 @10:09AM (#28275958)

Why isn’t the EUA process the default then? It sounds like manufacturing being after approval would just be a cost thing producers could figure out without needing the FDA involved…?

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

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Re:FDA Approves First Covid-19 Vaccine by icegreentea2 on Monday August 23, 2021 @10:28AM (#28276267)

EUA can be applied to many different product categories including diagnostics (basically every single PCR and antigen test in the US up to very recently was initially released under EUA), therapeutics (for example the FDA granted an EUA on chloroquine for threatment of COVID), other medical devices (for example PPE) and vaccines.

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.

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Re:FDA Approves First Covid-19 Vaccine by vlovich123 on Monday August 23, 2021 @11:03AM (#28276871)

> 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!

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Re:FDA Approves First Covid-19 Vaccine by ceejayoz on Monday August 23, 2021 @10:15AM (#28276042)

Vaccines are pretty low margin. Jumping straight to production for a vaccine that winds up not approved would prove pretty expensive, and most of them aren't an emergency scenario that would justify that risk.

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Re:FDA Approves First Covid-19 Vaccine by vlovich123 on Monday August 23, 2021 @11:01AM (#28276828)

You've answered why the government guaranteed purchases of the vaccine & why production was parallelized. That doesn't answer the question why this changes the FDA authorization flow because in the flow chart EUA & full approval happen at roughly the same time & the claim is they have the same safety requirements profile (i.e. I am free to burn money & produce something someone doesn't buy - why would the FDA be involved).

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

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