FDA Greenlights Moderna's mNEXSPIKE for Seniors
The FDA has approved Moderna's next-generation COVID-19 vaccine, mNEXSPIKE, for individuals aged 65 and above and those aged 12 to 64 with underlying risks. Under Robert F. Kennedy Jr.'s leadership, regulatory scrutiny has increased. The vaccine's storage advantage aids its distribution in developing countries facing supply-chain challenges.
The U.S. Food and Drug Administration has approved Moderna's mNEXSPIKE COVID-19 vaccine for those 65 and older. Moderna announced the news on Saturday, marking the first approval after the FDA heightened its regulatory requirements.
Approved for individuals aged 12 to 64 with certain health risks, the mNEXSPIKE vaccine reflects increased oversight by the Department of Health and Human Services, led by vaccine skeptic Robert F. Kennedy Jr.
While developed for various age groups, the vaccine will require booster testing against a placebo in adults under 65, as per the FDA's guidelines. With its ability to be stored in refrigerators, the vaccine promises easier distribution, particularly in regions with supply hurdles.
(With inputs from agencies.)
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