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Moderna, FDA and Covid

FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S. that will no longer be administered under an emergency use authorization.

Clinical Advisor · 6h

FDA Fully Approves Moderna’s COVID Vaccine for Some Young Kids

The FDA action comes weeks after US Health Secretary Robert F. Kennedy Jr said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.

BioSpace · 3d

Moderna Wins Full Approval for COVID-19 Shot for Higher-Risk Kids

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine and an RSV shot.

19hon MSN

Moderna gets full FDA approval for kids COVID-19 vaccine

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

Zacks.com on MSN3h

FDA Accepts GSK Filing for Expanded Use of RSV Shot in Younger Adults

Arexvy is currently approved for use in all individuals aged 60 and older, as well as for high-risk individuals aged 50-59.

GlobalData on MSN8h

GSK eyes FDA label expansion for RSV vaccine Arexvy to include younger patients

The label expansion sought by GSK is a bid to compete with Pfizer and Moderna in the younger age groups of the RSV vaccine market. Pfizer’s Abrysvo and Moderna’s mRESVIA are both approved to prevent ...

STAT4d

Pharmalittle: We’re reading about Regeneron’s patent maneuvers, FDA rejection letters, and lots more

A court battle between Regeneron and Amgen is testing the legal limits of how far drugmakers can go in using patents to ...

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