The FDA finally approved Novavax's Covid-19 vaccine, but placed restrictions on it that its two competitors in the U.S. do not face

The policy has been outlined in an editorial in the New England Journal of Medicine (NEJM) by FDA Commissioner Marty Makary and Vinay Prasad, who was just appointed director of the agency's Center for Biologics Evaluation and Research (CBER).

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

Some members of the Vaccines and Related Biologics Products Advisory Committee worried that a strain change would require new testing that could delay delivery of vaccines for the fall.

WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation’s top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.

The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.'s COVID-19 vaccine, restricting its use to people 65 and older and those 12 and up with underlying health conditions that increase risk of severe illness.