Might be interesting to keep an eye on other regulators’ responses by way of comparison. Looks like the UK conditionally approved it a while ago, on Nov 4:
News articles said it was approved for those with a risk factor but I don’t see that mentioned in the approval doc itself (maybe it would not be expected to show up there and would be in a different doc). Not recommended if you are pregnant but no pregnancy test requirement.
“Molnupiravir was negative for induction of chromosomal damage in in vitro micronucleus (with and without metabolic activation) and in vivo rat micronucleus assays. Based on the totality of the genotoxicity data, molnupiravir is of low risk for genotoxicity or mutagenicity in clinical use.” - so they didn’t make as much of the mutagenicity concerns and the FDA.
Given that 10% of the placebo cases ended up being hospitalised (which seems slightly high to me), doesn't that mean that you would need to have 100 people take Molnupiravir to avoid 3 of them being hospitalised? Adding to that the risk of mutations and the possibility of cancer (? I don't know how legit that is: https://www.forbes.com/sites/williamhaseltine/2021/11/02/harming-those-who-receive-it-the-dangers-of-molnupiravir-part-2/), maybe it makes sense to authorise if only for high-risk individuals?
Might be interesting to keep an eye on other regulators’ responses by way of comparison. Looks like the UK conditionally approved it a while ago, on Nov 4:
https://www.gov.uk/government/publications/regulatory-approval-of-lagevrio-molnupiravir/summary-of-product-characteristics-for-lagevrio
News articles said it was approved for those with a risk factor but I don’t see that mentioned in the approval doc itself (maybe it would not be expected to show up there and would be in a different doc). Not recommended if you are pregnant but no pregnancy test requirement.
“Molnupiravir was negative for induction of chromosomal damage in in vitro micronucleus (with and without metabolic activation) and in vivo rat micronucleus assays. Based on the totality of the genotoxicity data, molnupiravir is of low risk for genotoxicity or mutagenicity in clinical use.” - so they didn’t make as much of the mutagenicity concerns and the FDA.
Because of you, I learned Delenda Est, and my understanding is that this should have ended with:
9. FDA Delenda Est.
Link: https://en.wikipedia.org/wiki/Carthago_delenda_est#:~:text=Cato%20is%20said%20to%20have%20used%20the%20phrase%20as%20the%20conclusion%20to%20all%20his%20speeches%20to%20push%20for%20the%20war
Given that 10% of the placebo cases ended up being hospitalised (which seems slightly high to me), doesn't that mean that you would need to have 100 people take Molnupiravir to avoid 3 of them being hospitalised? Adding to that the risk of mutations and the possibility of cancer (? I don't know how legit that is: https://www.forbes.com/sites/williamhaseltine/2021/11/02/harming-those-who-receive-it-the-dangers-of-molnupiravir-part-2/), maybe it makes sense to authorise if only for high-risk individuals?