What the FDA’s New Rules for Covid Vaccines Mean: QuickTake

May 21, 2025, 3:45 PM UTC

The US Food and Drug Administration on May 20 announced new testing requirements that are expected to curtail access to Covid vaccines for healthy people under 65. The policy marks a dramatic shift in US regulators’ approach to such shots, previous versions of which were quickly approved and recommended to everyone 6 months of age and older, typically in the form of an annual booster.

Companies won’t have to do more clinical trials to sell Covid vaccines to Americans older than 65 and those with certain medical conditions, the agency said. But immunizations for everyone else likely won’t be approved without additional ...

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