U.S. Food and Drug Administration Commissioner Marty Makary has had a lot to say lately about COVID-19 vaccines ¡ª 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.¡±
With your current subscription plan you can comment on stories. However, before writing your first comment, please create a display name in the Profile section of your subscriber account page.