One article I read was pointing out that the timing of delta effectiveness studies is key, as the base rates of vaccinations and delta changed rapidly with each other. I can't find it now but it was suggesting that because of this it's important to focus on studies from later periods when both were higher.
I understand the arguments that booster timing is probably important, and that increasing vaccination rates is more important than boosters. However:
1. The idea that you're going to magically just make everyone unvaccinated get vaccinated seems like a questionable assumption. Maybe this is something to read between the lines, that the FDA is pushing to mandate vaccinations instead (thus Biden's announcements). But then they should be clear that that's where they're going. In the meantime, you're spiting the already vaccinated to try to control the unvaccinated. Is this what we want from the FDA?
2. There's this oft-repeated assertion that boosters should be held off to increase vaccine supply. But is there any evidence that administering boosters would affect 1st-2nd dose availability? We've had these available for months now and I'm very skeptical that administering boosters would do anything other than use up supplies that are sitting there unused.
Meanwhile by the time the FDA acts we'll be in the third major variant phase.
Yes, severe illness among the vaccinated is rare. But every one of those cases that could have been protected by a booster was a preventable case.
From my perspective, it is not the FDA (or the government's) job to evaluate the need for approval of a booster. It's their job to evaluate the safety of a booster product being sold. I would go so far as to say even if the booster did nothing, if it was safe, it should be approved (note that it has already been given full approval, really). But with evidence that it does something it should doubly so be approved.
The FDA already approved the vaccine. It's not their job to approve when it it is given. That's between someone and their provider.
> From my perspective, it is not the FDA (or the government's) job to evaluate the need for approval of a booster. It's their job to evaluate the safety of a booster product being sold.
Effectiveness, as well as safety, is explicitly part of the FDA mandate for approvals generally. That's not precisely need, but since it incorporates marginal impact, it is quite closely related.
> The FDA already approved the vaccine. It's not their job to approve when it it is given
This is wrong. The FDA doesn't issues generic approvals, it issues approvals for specific uses.
> > The FDA already approved the vaccine. It's not their job to approve when it it is given
> This is wrong. The FDA doesn't issues generic approvals, it issues approvals for specific uses.
Actually, it is correct. There are many drugs that are used for non-approved purposes after having been found to have additional properties.
This is what the FDA says to specifically address this.
"Why might an approved drug be used for an unapproved use?
From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition." [1]
I never said anything about that, and neither did derbOac. But, it is meaningless to say that the FDA approves for a purpose, since drugs are used for many off-label purposes.
https://www.science.org/content/article/israel-s-covid-19-bo...
https://www.science.org/news/2021/08/grim-warning-israel-vac...
https://www.ndm.ox.ac.uk/files/coronavirus/covid-19-infectio...
https://www.statnews.com/2021/08/24/as-delta-spread-covid-19...
One article I read was pointing out that the timing of delta effectiveness studies is key, as the base rates of vaccinations and delta changed rapidly with each other. I can't find it now but it was suggesting that because of this it's important to focus on studies from later periods when both were higher.
I understand the arguments that booster timing is probably important, and that increasing vaccination rates is more important than boosters. However:
1. The idea that you're going to magically just make everyone unvaccinated get vaccinated seems like a questionable assumption. Maybe this is something to read between the lines, that the FDA is pushing to mandate vaccinations instead (thus Biden's announcements). But then they should be clear that that's where they're going. In the meantime, you're spiting the already vaccinated to try to control the unvaccinated. Is this what we want from the FDA?
2. There's this oft-repeated assertion that boosters should be held off to increase vaccine supply. But is there any evidence that administering boosters would affect 1st-2nd dose availability? We've had these available for months now and I'm very skeptical that administering boosters would do anything other than use up supplies that are sitting there unused.
Meanwhile by the time the FDA acts we'll be in the third major variant phase.
Yes, severe illness among the vaccinated is rare. But every one of those cases that could have been protected by a booster was a preventable case.
From my perspective, it is not the FDA (or the government's) job to evaluate the need for approval of a booster. It's their job to evaluate the safety of a booster product being sold. I would go so far as to say even if the booster did nothing, if it was safe, it should be approved (note that it has already been given full approval, really). But with evidence that it does something it should doubly so be approved.
The FDA already approved the vaccine. It's not their job to approve when it it is given. That's between someone and their provider.