FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

In a major policy change, the Food and Drug Administration has announced a plan to limit access to future COVID-19 shots only to people over 65 years old or those with an underlying health condition.

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at higher risk of severe disease, but will require vaccine makers to conduct major new clinical trials before approving them for wider use.

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.

In this week’s edition of InnovationRx, we look at the FDA's new rules on Covid-19 vaccines, Novartis’s acquisition strategy, Medtronic’s diabetes spinoff, Regeneron’s purchase of 23AndMe, and more.

Regulators say updated booster shots won’t be approved for healthy people under age 65 unless drugmakers conduct new trials.

The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to green-lighting shots that have been recommended broadly to the public.

Moderna filed for FDA approval of its mRNA-1083 combination shot last year. The submission put the biotech on track to win approval in adults aged 50 and older in November 2025. However, at the start of May, Moderna pushed back the expected approval date to 2026 after the FDA asked to see phase 3 efficacy before making a decision on authorization.