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FDA Setting Higher Bar for Emergency Covid Vaccine Clearance

Drugmakers seeking an emergency authorization for a Covid-19 vaccine will have to meet a higher standard of efficacy than normally would be required for such a clearance, the head of the U.S. Food and Drug Administration’s office that handles vaccines said.

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 Thursday that the agency will require more robust data about how well a coronavirus vaccine works before granting an emergency waiver — something he called “EUA plus.”

FDA Commissioner Stephen Hahn tweeted later Thursday that the agency planned to release guidelines for drugmakers that aim to submit an EUA request for a Covid-19 vaccine.


Hahn also tweeted that the guidelines for an EUA would lay out the type of data the FDA expects. This builds on guidance the agency put out in June that said any Covid-19 vaccine should be at least 50% effective.

Marks said the data requirement will more closely mimic the 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 get the vaccine to Americans more quickly, he said.

The efficacy and safety data required are expected to “indicate to us that we have a product that’s going to do what it’s intended to do,” Marks said at a Research! America conference. He said that once a vaccine reaches the market there will be additional safety monitoring.

The medical community has raised concerns about allowing a vaccine on the market under emergency authorization, rather than the regular FDA approval process, particularly given President Donald Trump’s push to have a shot available by the Nov. 3 election. Career FDA officials, including Marks, wrote an opinion piece on Thursday in USA Today attempting to reassure skeptics they are following the science, not politics.

Speaking earlier Thursday at an Economic Club of Washington event, Hahn said when asked when a shot might be authorized that the agency hasn’t yet received data on any of the vaccines in clinical trials.

“I don’t have a crystal ball,” Hahn said. “It would be really inappropriate for me to speculate. We haven’t seen the clinical data. There’s no way for me to possibly know when that’s going to come to us.”