AnnieA
Well-known Member
- Location
- Down South
Straight from the horse's mouth:
https://www.fda.gov/drugs/information-healthcare-professionals-drugs/accelerated-approval-program
(Emphasis mine)
With Accelerated Approval, the surrogate endpoint such as showing vaccines produce antibodies is enough for the FDA to grant approval for use in the US.
Phase 4 trials--which show whether the product actually provides clinical benefit--are completed after the product goes out for use in the general population. In the standard (not accelerated) research process, Phase IV is required before approval.
So basically, the first people to get the vaccine are actually Phase IV trial subjects.
Pharmaceutical companies will do the studies for Phase IV after the roll out and the FDA will review them at which point the product may get traditional approval or may lose its approval altogether.
https://www.fda.gov/drugs/information-healthcare-professionals-drugs/accelerated-approval-program
(Emphasis mine)
The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
With Accelerated Approval, the surrogate endpoint such as showing vaccines produce antibodies is enough for the FDA to grant approval for use in the US.
Phase 4 trials--which show whether the product actually provides clinical benefit--are completed after the product goes out for use in the general population. In the standard (not accelerated) research process, Phase IV is required before approval.
So basically, the first people to get the vaccine are actually Phase IV trial subjects.
Pharmaceutical companies will do the studies for Phase IV after the roll out and the FDA will review them at which point the product may get traditional approval or may lose its approval altogether.
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