White House

HEALTH CARE BRIEFING: Higher Bar Set for Rapid Vaccine Clearance

Drugmakers seeking an emergency authorization for a coronavirus vaccine will have to meet a higher standard of efficacy than normally would be required for such clearance, the head of the Food and Drug Administration’s office handling vaccines said yesterday.

Typically, an emergency use authorization, or EUA, would require a company to show their product may be effective. Peter Marks, director of the FDA’s biologics office, said the FDA will require more robust data about how well a coronavirus vaccine works before granting an emergency waiver, which he called “EUA plus.”

Marks said the data requirement will more closely mimic standards that apply for an application for a regular approval. The emergency pathway will be used mostly to help shed some paperwork and technical requirements to help push out a vaccine to Americans more quickly, he said.

Read more…