RELATED: Pfizer to apply for emergency use of its COVID-19 vaccineDuring a health crisis, the FDA can loosen its normal scientific standards to allow emergency use of experimental drugs, devices, vaccines and other medical products.
The first vaccines to get the provisional green light in the U.S. are almost certain to be made available under this process, known as emergency use authorization.Instead of the usual requirement of “substantial evidence” of safety and effectiveness for approval, the FDA can allow products onto the market as long as their benefits are likely to outweigh their risks.
It has already used its emergency powers to authorize hundreds of coronavirus tests and a handful of treatments during the pandemic.AdvertisementIn.