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Comment by jschwartzi | Hacker News Reader

In the article it says that these doses were produced in a facility that wasn't approved by the FDA yet, so this has no impact on the availability of doses now. It might have an impact on the availability of doses in the future though.

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Honest question: if the facility wasn't approved by the FDA then why was it manufacturing the vaccines at all?

And how could such vaccines be used anywhere if they were produced by an unapproved facility?

FDA is likely reviewing their processes and controls more than running a white glove inside of anything.

So those things would be the same for a batch that was in production as they would be for a batch started tomorrow.

Maybe the approval process includes a "must have met X criteria for the past Y months", so once you get approved, everything you've done in the past Y months counts as having been created in an approved facility. I'm just guessing though, I have no idea what the process is.

Basically this. You need four consecutive batches with consistent quality in a row for approval.

Everyone has been gearing up production before approvals with the assumption they'll get approved for expediency sake.

You get approved? Great - We can immediately ship these 30 million doses while we start the next 30 million.

We don't get approved? Write off the produced doses, fix your process, and try again.

Maybe making them for another country?

Because that's how good we are as a society at efficiently allocating capital and operating supply chains. Regulators have to sign off before you can administer it to anyone but you can ramp up your production in parallel with the approval process.

It's actually an incredible achievement.

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