U.S. Food and Drug Administration Commissioner Marty Makary has had a lot to say lately about COVID-19 vaccines — much of it seemingly intended to undermine confidence and cast doubt on the future of the shots.
But a policy shift reported late Wednesday hints at a larger and more disturbing issue: Health and Human Services Secretary Robert F. Kennedy Jr., who oversees the FDA, intends to set new regulatory standards vaccine manufacturers couldn’t possibly meet. The shift could immediately affect access to COVID-19 boosters and adds uncertainty to the development of other new vaccines.
The drama began with Novavax’s COVID-19 vaccine, which was given conditional approval in 2022. Full approval was expected on April 1. When that date came and went, the question became: Was the delay a symptom of an FDA hobbled by recent staffing and budget cuts or an indication of a change in the agency’s stance on COVID-19 vaccines? Kennedy stoked fears of the latter when he falsely claimed in an interview with CBS that vaccines like Novavax’s protein-based shot have "never worked.”
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