FDA, Pfizer Revising COVID-19 Vaccine Guidelines on Side Effects

FDA, Pfizer Revising COVID-19 Vaccine Guidelines on Side Effects FDA, Pfizer Revising COVID-19 Vaccine Guidelines on Side Effects (Nathan Howard/Getty Images)

Anna Edney Thursday, 17 December 2020 11:03 AM

Pfizer Inc. and U.S. drug regulators are revising information for use and monitoring of the company’s COVID-19 vaccine developed with BioNTech SE after rare allergic reactions were seen in some recipients.

The revisions reflect guidelines from the Centers for Disease Control and Prevention for following vaccine recipients and managing potential reactions, Doran Fink, deputy director of FDA’s division of vaccines and related products applications, said Thursday in a meeting of FDA advisers.

The advisory panel meeting, called to consider whether to recommend Moderna Inc.’s coronavirus vaccine for emergency use authorization, began with a focus on the allergic reactions. Two people in Alaska who received the Pfizer-BioNTech vaccine suffered the reactions, which have also seen in vaccine recipients in the U.K.

“At this point, we and CDC are continuing to investigate these cases and consider data,” Fink said. “As we continue to evaluate and investigate the data, we will determine whether additional recommendations need to be made.”