The standard for authorizing any eventual coronavirus vaccine will be like an “emergency use authorization plus,” a top US Food and Drug Administration official said Thursday.
FDA requirements will be stricter than for an emergency use authorization for an experimental drug, said Dr. Peter Marks, who heads FDA’s Center for Biologics Evaluation and Research. But it will not be as stringent as the requirements for full licensure.
“For us, for a vaccine for which there is adequate manufacturing information, if we going to do an emergency use authorization, it is going to really be like an emergency use authorization plus,” Marks told a seminar hosted by Duke University’s Margolis Center for Health Policy.
Vaccines are not licensed as drugs, but rather as biologics under a Biologics License Application or BLA.
Emergency use authorization is a “relatively low bar,” Marks said. “It’s a product that may be effective,” he added.
A BLA requires substantial data from controlled clinical trials showing the product is effective. “Along that spectrum it is going to be closer to the BLA, even though that is not going to be exactly identical,” Marks said.
Usually, a full license requires details about how a product would be manufactured, along with extensive safety data from months of follow-up. “But the substantial information about efficacy and the most important information regarding safety will be there,” Marks said.
Source : CNN