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Comment by Anon84 | Hacker News Reader

Yes, you need to show that the new vaccine works against the new variant but not that it’s safe. So it will be much faster

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They still need to do Phase 2...I don't where you got your info from, but it's very misleading.

Why would you not need to show it’s safe? A new mRNA vaccine would be introducing different mRNA, which produces new antigen proteins and elicits a different immune response.

Yeah i'm pretty pro vaccine but it seems like safety should be evaluated because it's creating a different antigen. maybe this is some relic from the flu-shots being made yearly without any real safety testing to my knowlege(which, to be fair for the flu, I haven't really followed so i don't know how accurate that is but i don't think much meaningful safety testing can be done every year)

If it elicited the same immune response it wouldn't be much of a use though, right ?

Anyway, how do they know the usual but new seasonal flu vaccine is safe ? Can't the same framework apply ?

They run clinical trials on them to make sure they are safe and effective.

https://www.cdc.gov/flu/vaccines-work/effectivenessqa.htm

Manufacturers guess which flu strain will predominate and start working 9-12 months early to capture the data for approval.

There is no way a new Covid mRNA vaccine will be approved with safety and efficacy data from a clinical trial. That will be take months to complete.

It's possible that mRNA would reduce the time to the market, which would give use more time to gather data and have better predictions of dominant strains.

> There is no way a new Covid mRNA vaccine will be approved with safety and efficacy data from a clinical trial.

You meant 'without', right?

Wow, thanks. I didn't know that they had an extensive clinical trial program and that the whole thing started so soon.

You would think software engineers would understand this. It's like approving subsequent pull requests on any and all code changes because the integration tests already passed once.

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