BioCentury
ARTICLE | Product Development

FDA’s ‘pause’ could lead to narrowed indication for J&J COVID-19 vaccine

Concerns about adenoviral vectors could delay or sink AZ’s vaccine in U.S.

April 13, 2021 7:41 PM UTC

FDA’s non-binding decision to recommend a “pause” in the use of Johnson & Johnson’s COVID-19 vaccine was among the least strenuous measures it could have taken in response to adverse event reports. The action, which Acting FDA Commissioner Janet Woodcock told reporters will be in effect for “a matter of days,” leaves the door open for scaling back the indication. 

The agency has not withdrawn or modified the emergency use authorization for Ad26.COV2.S, the single-dose adenoviral vector vaccine from the Janssen unit of Johnson & Johnson (NYSE:JNJ)...