The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials.

SHELTON, CT / ACCESS Newswire / May 22, 2025 / Dr. Anil Diwan, President of NanoViricides, Inc. (NYSE Amer.:NNVC ) (the “Company”), comments on the new COVID Vaccine policy adopted by the US FDA. The new FDA COVID Vaccine Booster Shots policy [1] is based on the findings that the groups that benefit from repeat

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.

Yesterday the Vaccine Integrity Project (VIP), a panel of leading public health and policy experts, published a viewpoint on the Food and Drug Administration's (FDA's) decision this week to issue new, more restrictive, COVID-19 vaccine recommendations via an opinion piece in the New England Journal of Medicine (NEJM).

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

As the Trump administration’s FDA moves to limit approval for COVID-19 booster shots, millions of Americans under 65 may find themselves without access this fall. However, until Friday, there’s still time to influence this decision, pro or con, through the FDA’s public comment portal.

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.

President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could spell major changes in what is required to get regulatory approval for immunizations.