FDA approves updated Covid vaccines with restricted eligibility

Published 27/08/2025, 19:10
FDA approves updated Covid vaccines with restricted eligibility

Investing.com -- The U.S. Food and Drug Administration on Wednesday approved updated Covid-19 vaccines targeting strains related to the JN.1 variant, but with significantly narrowed eligibility requirements compared to previous years.

The new shots will be available primarily to people 65 and older and those with underlying health conditions that increase their risk from Covid-19. Other individuals over 6 months old can still receive the vaccines with a doctor’s approval, a change from last year when everyone was eligible without requiring physician consultation.

This restricted approach follows actions by Health and Human Services Secretary Robert F. Kennedy Jr., who earlier this year pledged to end Covid vaccine mandates while keeping vaccines available for vulnerable populations.

Kennedy stated that the FDA’s actions accomplished his four goals: ending Covid vaccine mandates, keeping vaccines available for those who want them (especially vulnerable people), demanding placebo-controlled trials from companies, and ending the emergency.

"The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded," Kennedy wrote.

The FDA approved updated formulations from Moderna, Pfizer, and Novavax. Moderna announced that its Spikevax is approved for individuals 6 months through 64 years with high-risk conditions and all adults 65 and older. The company’s mNEXSPIKE vaccine received approval for high-risk individuals aged 12 through 64 and all adults 65 and older.

Moderna CEO Stéphane Bancel emphasized the importance of protecting vulnerable populations, noting that "COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalizations last year."

Shares of vaccine manufacturers Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), and Novavax (NASDAQ:NVAX) were little changed following the announcement.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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