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Moderna Files With FDA for Updated Covid Shot

By Dean Seal

 

Moderna has applied for the U.S. Food and Drug Administration to review its new Covid-19 shot that targets a variant of the virus recently flagged by regulators.

The vaccine maker said Friday that it wants the FDA to review its Spikevax 2024 and 2025 formula, which fights the variant known as JN.1.

The FDA's Vaccines and Related Biological Products Advisory Committee voted earlier this week to recommend that all Covid-19 vaccines be updated to monovalent JN.1-lineage composition for the upcoming season.

The World Health Organization and European Medicines Agency have already made similar recommendations.

Moderna said it is submitting data to regulators around the world to support the registration and supply of the updated vaccine.

The most commonly cited adverse events for Moderna's updated vaccine were injection site pain, headache, fatigue, myalgia and chills, the company said.

 

Write to Dean Seal at dean.seal@wsj.com

 

(END) Dow Jones Newswires

June 07, 2024 11:30 ET (15:30 GMT)

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