> 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.
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.