U.S. health officials inject new uncertainty into approval process for Covid boosters
Confusion over the FDA delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend, with possible implications for Pfizer and Moderna.
Confusion over the Food and Drug Administration’s delay in granting full approval to Novavax’s Covid-19 vaccine deepened over the weekend when the agency’s commissioner, Marty Makary, took to social media to defend the FDA’s controversial handling of the company’s submission.
In the process, Makary and a spokesman for the Department of Health and Human Services appeared to raise the specter that, going forward, manufacturers of Covid vaccines might have to generate new effectiveness data before the release of annual updates of their vaccines — a hurdle they would be unlikely to clear to vaccinate people in time to protect them when Covid transmission is occurring.
