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by alaxsxaq 1828 days ago
This is from the FDA website.

"Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives."

You should probably drill into this if you are interested, but the phrasing most often referenced by people talking about effective therapeutics and the lack of approval by the FDA is, "there are adequate, approved, and available alternatives."

2 comments

The idea that ivermectin (even if it works, and gets approved for this usage, which'd likely take as long as the vaccines are taking to get to that point) is an adequate alternative to a vaccine, which provides ongoing, lasting protection, is silly.

It'd be like claiming the existence of the iron lung is sufficient to yank the polio vaccine out of production.

For example, Remdesivir is approved, without any sign of that fact jeopardizing the EUA on the vaccines. https://www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-op...

> FDA has approved one drug, remdesivir (Veklury), for the treatment of COVID-19 in hospitalized patients aged 12 years and older who weigh at least 40 kg.

Can you point to anything that says the FDA would consider HCQ or any of these other drugs as alternatives to vaccines? They are not the same, and though they could both treat COVID, my reading is not that this would limit vaccine emergency authorization if there was a non vaccine treatment. This is especially true considering there are multiple vaccines approved under emergency use which would be direct competitors. So, nope, I don't buy it from just this wording. I need something saying specifically that alternative treatments would stop a vaccine being approved.
I get vaccinated for flu every year. And yet there is Tamiflu, an effective palliative.
I believe it means vaccines should go typical testing and vetting process, not the emergency shortened, is what the op wanted to tell.
I understand that's what op is trying to say, but op isn't providing sufficient evidence for that. Non vaccines are not alternatives for vaccines. And we have EUAs for things that would be alternatives to each other, multiple vaccines. So there's not reason to think a viable treatment for COVID would prevent a vaccine from getting a EUA.