Now Pfizer press release today says they expect under-5 data "later in the quarter." And Bourla tweeted that they'll update people "in the coming weeks." Again, after initially saying early April.
It sure seems like the 3-dose schedule didn't work as they'd hoped...
You wrote, "That said, molnupiravir has raised some eyebrows because it might be mutagenic—something I am only concerned about in growing children or pregnant people, frankly—and PAXLOVID has a lot of potential drug-drug interactions. So there may be a population of people who need a third option, and I think that remdesivir could be a good candidate there. There are, of course, also some antibody cocktail options that work well. We are accumulating a deep bench of tools to fight COVID-19 in those rare cases where vaccination isn’t enough."
How about cocktails of multiple antivirals? What would, say, remdesivir+molnupiravir do to the virus? Answer: we don't know, but I sure hope somebody's testing it.
My hospital is still giving remdesivir to vaccinated patients and keeping them in the hospital for the entire course. I find this mind boggling. The risks of remdesivir and hospitalization itself must be higher than the meager, if any, benefit to a vaccinated adult. It's an interesting option for unvaccinated outpatients, but giving a five day course of an IV medication in the outpatient setting is challenging at best, probably closer to impossible.
The strangest thing to me about the pediatric vaccine kerfuffle is what's going on with Pfizer. Months ago, they said they'd have data ready in early April. Now it's almost May, and they're apparently aiming for a June authorization. Things happen, I know; yet the lack of any acknowledgment of the shifting timeline, much less any explanation for it, is perplexing.
As far as the FDA goes, gaming out ways to use the regulatory process to increase uptake of vaccines far exceeds the agency's mandate. It's misguided, but it's also arguably illegal.
Additionally, it's hard for me to fathom why the FDA has sat on Moderna's EUA request for adolescents for about a year now, while other countries authorized Moderna for 7+. The official explanation -- they needed more time to evaluate relative myocarditis risks -- strains credulity at this point. If review will take longer because of the need to evaluate older age groups first, then that's a predicament for which the FDA bears significant responsibility.
I know of no direct evidence of FDA favoritism toward Pfizer. But regulatory bodies have an obligation to avoid even the *appearance* of favoritism, and the FDA is failing in that regard.
https://www.nature.com/articles/d41586-022-01112-4
SARS-CoV-2 becoming endemic in white-tailed deer? Maybe.
Now Pfizer press release today says they expect under-5 data "later in the quarter." And Bourla tweeted that they'll update people "in the coming weeks." Again, after initially saying early April.
It sure seems like the 3-dose schedule didn't work as they'd hoped...
You wrote, "That said, molnupiravir has raised some eyebrows because it might be mutagenic—something I am only concerned about in growing children or pregnant people, frankly—and PAXLOVID has a lot of potential drug-drug interactions. So there may be a population of people who need a third option, and I think that remdesivir could be a good candidate there. There are, of course, also some antibody cocktail options that work well. We are accumulating a deep bench of tools to fight COVID-19 in those rare cases where vaccination isn’t enough."
How about cocktails of multiple antivirals? What would, say, remdesivir+molnupiravir do to the virus? Answer: we don't know, but I sure hope somebody's testing it.
My hospital is still giving remdesivir to vaccinated patients and keeping them in the hospital for the entire course. I find this mind boggling. The risks of remdesivir and hospitalization itself must be higher than the meager, if any, benefit to a vaccinated adult. It's an interesting option for unvaccinated outpatients, but giving a five day course of an IV medication in the outpatient setting is challenging at best, probably closer to impossible.
The strangest thing to me about the pediatric vaccine kerfuffle is what's going on with Pfizer. Months ago, they said they'd have data ready in early April. Now it's almost May, and they're apparently aiming for a June authorization. Things happen, I know; yet the lack of any acknowledgment of the shifting timeline, much less any explanation for it, is perplexing.
As far as the FDA goes, gaming out ways to use the regulatory process to increase uptake of vaccines far exceeds the agency's mandate. It's misguided, but it's also arguably illegal.
Additionally, it's hard for me to fathom why the FDA has sat on Moderna's EUA request for adolescents for about a year now, while other countries authorized Moderna for 7+. The official explanation -- they needed more time to evaluate relative myocarditis risks -- strains credulity at this point. If review will take longer because of the need to evaluate older age groups first, then that's a predicament for which the FDA bears significant responsibility.
I know of no direct evidence of FDA favoritism toward Pfizer. But regulatory bodies have an obligation to avoid even the *appearance* of favoritism, and the FDA is failing in that regard.