BioCentury
DATA GRAPHICS | Data Byte

FDA approved new COVID vaccine, three NMEs in May

Total YTD NME approvals stand at 13

June 4, 2025 12:30 AM UTC

FDA approved Moderna’s next-generation COVID-19 vaccine late Friday, indicating HHS Secretary Robert F. Kennedy Jr.’s vaccine skepticism has not fully permeated agency decisions.

mNexspike from Moderna Inc. (NASDAQ:MRNA) was granted full approval for use in individuals age 65 or older and those age 12-64 with a risk factor for severe Covid-19 infection, consistent with FDA thinking recently outlined in The New England Journal of Medicine. ...

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