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FDA approves a next-generation Covid vaccine from Moderna, with restrictions

The Food and Drug Administration approved Moderna’s new Covid-19 vaccine late Friday, though it placed restrictions on its use that the company’s existing Covid shot, Spikevax, does not currently face.

The new vaccine, which will be marketed under the name mNexspike, will not immediately replace Spikevax. A statement from the company said both vaccines will be available on the market for the time being.

“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from Covid-19,” Moderna CEO Stéphane Bancel said in the statement. “Covid-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”

As it did earlier this month with Novavax’s Covid vaccine, the FDA said the new Moderna shot is licensed for use only in people aged 65 and older and people aged 12 to 64 who have at least one medical condition that puts them at increased risk of becoming seriously ill if they contract the SARS-CoV-2 virus. Such conditions include diabetes, chronic obstructive pulmonary disorder or COPD, and obesity.

Spikevax’s license allows its use in people aged 12 years and older.