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COVID, FDA and Moderna

USA TODAY · 11h

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,

CBS News on MSN · 2d

FDA expands COVID vaccine warning about heart side effect risk for young males

The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis and pericarditis.

U.S. News & World Report · 1d

FDA Warns of Heart Risk With Pfizer, Moderna COVID Vaccines

The updated warnings highlight a rare risk of heart inflammation in teen boys and young men, CBS News reported. The warning applies to males ages 16 to 25 and is based on new data from FDA safety monitoring and a 2023 study. This includes both Pfizer's Comirnaty and Moderna's Spikevax vaccines.

FDA, COVID-19 vaccine

USA TODAY on MSN · 1d

Changes are happening around COVID-19 vaccines: Here's what to know

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

FDA to restrict COVID vaccine access

Changes are on the way to COVID vaccines, thanks to a new policy by the Trump administration. The changes by the FDA mean restricting access to who can get seasonal COVID shots—limiting approval to seniors over 65,

Boise State Public Radio · 1d

Vaccine advisers to the FDA recommended changes to COVID vaccines

Advisers to the Food and Drug Administration met Thursday to help decide which variant of the virus that causes COVID should be targeted by updated versions of the vaccines.

2don MSN

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 ...

15hon MSN

Moderna files application for updated COVID vaccine

Moderna said on Friday it had filed a marketing application for an updated COVID vaccine to the U.S. Food and Drug ...

The Manila Times1h

Moderna's updated Covid vaccine for review

MODERNA said on Friday it has filed a marketing application for the review of its updated Covid-19 vaccine with the US Food and Drug Administration (FDA).

1d

Moderna Pulls Promising Covid-Flu Combo Shot as RFK Continues Antivax Campaign

Moderna isn’t giving up on the combo shot entirely—it plans to resubmit later this year after it collects more data from its ...

2don MSN

Moderna pulls application for COVID-flu combination shot

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine ...

BioPharma Dive2d

Moderna pulls application for combo COVID, flu shot

The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from ...

3don MSN

Covid vaccine rollout for healthy kids and adults likely delayed by new FDA rule

The rollout of updated Covid vaccines for healthy children and adults this fall is likely to be delayed after the FDA said it ...

Live Science on MSN4d

2-in-1 COVID-flu vaccine looks promising in trial — but experts say approval may be delayed

Late-stage trial data suggest that a new COVID-flu vaccine offers good protection against both infections, but experts expect ...

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