U.S. FDA approves Moderna's next-generation COVID-19 vaccine

發佈日期: 2025-06-03 20:08
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The U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the first endorsement since the regulator tightened requirements.

The vaccine called mNEXSPIKE has also been approved for people aged 12 to 64 with at least one or more underlying risk factors defined by the Centers for Disease Control and Prevention.

Moderna said it expects to have the vaccine available for the 2025 to 2026 respiratory virus season.

The U.S. Department of Health and Human Services under the leadership of long-time vaccine sceptic Robert F. Kennedy Jr. is tightening regulatory scrutiny on vaccines.

The FDA said on May 20 it planned to require drug makers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness.

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