Coronavirus Vaccine Efficacy Rate Set At 50% Because That’s What US FDA ‘Could Tolerate’
CBER Director Marks explains that too high a bar might result natural herd immunity before vaccine trials could be completed, while too low a threshold could result in approval of products with limited efficacy.
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US FDA has the unenviable task of picking the most important adverse events to track once coronavirus vaccinations begin; CDC's list will need to be winnowed to 10-20 to make the surveillance feasible, and which AEs make the cut may be informed by the vaccine trials, as well as clinical experience with COVID infections.
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.
The move reduces the pressure on the companies to rush development, but also relieves burden on the FDA to approve a candidate too soon.