The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over the age of 65 years and for all persons above the age of 6 months with

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

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new commissioner described as a “one-size-fits-all regulatory framework.”