Makary, Prasad tighten COVID-19 vaccine standards

New commentary from top officials at FDA signals that the COVID-19 vaccine market for adults 65 and older remains secure — but casts doubt on the viability of developing vaccines for younger populations. It also marks a major departure from previous clinical requirements for annual vaccines.

In a New England Journal of Medicine (NEJM) commentary, new FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad lay out revised clinical trial requirements for COVID-19 vaccines. For adults 65 and older, the current approach remains unchanged: immunogenicity data alone will continue to support approval of updated annual vaccines...