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FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation

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.

· 2d · on MSN

· 2d

FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

STAT · 1d

FDA gives Covid vaccine manufacturers instructions for next fall’s shot

The FDA may restrict COVID shots. Who will be able to get them?

The Food and Drug Administration announced this week that it was likely to limit access to COVID-19 vaccines among healthy children and adults this fall.

· 1d

MIT Technology Review · 1d

The FDA plans to limit access to covid vaccines. Here’s why that’s not all bad.

· 20h

Uncertainty loomed as FDA advisors met to discuss this year’s COVID shot

2don MSN

With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be included in this year’s Covid-19 vaccines,

23h

Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine

CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for review of its Spikevax 2025-2026 formula,

Vaccine critics head to Capitol Hill

Amid a growing distrust of vaccines and the medical community, there’s also been a growing divide in the Make America Healthy Again initiative.

5don MSN

RFK Jr. pledged not to upend US vaccine system, but big changes are underway

Health agencies working under Robert F. Kennedy Jr. are making changes to the nation's decades-old system for approving and recommending vaccines.

The New Rational FDA COVID Vaccine Policy is Long Overdue, Says NanoViricides’ Dr. Diwan

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