Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2

Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2

CAMBRIDGE, MA / ACCESS Newswire / August 27, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting…

FDA Greenlights New COVID-19 Shots, But Restricts Use on Young Children.

PULSE POINTSWHAT HAPPENED: The U.S. Food and Drug Administration (FDA) approved updated COVID-19 vaccines from Pfizer, Moderna, and Novavax, but limited their use for many Americans, including children under five.WHO WAS INVOLVED: FDA officials, Health Secretary Robert F. Kennedy Jr., and FDA Commissioner Marty Makary.WHEN & WHERE: The decision was announced Wednesday, with vaccines set to ship immediately across the United States.KEY QUOTE: “Th…

FDA Approves Moderna’s Updated COVID-19 Vaccines Targeting LP.8.1 Variant for Fall 2025

Spikevax and mNEXSPIKE authorized for older adults and high-risk individuals; experts emphasize protection against severe COVID-19 outcomes.

Game-Changing Vaccines, Breakthrough Drugs, and a CDC Shakeup: Biotech & Health News Roundup

In-Depth Report COVID-19 Vaccines and U.S. Public Health Upheaval Targeted Fall Boosters, But Access Tightened: U.S. health authorities approved new monovalent COVID-19 vaccines (by Pfizer–BioNTech, Moderna, and Novavax) updated for the 2025–26 season reuters.com. Unlike prior booster rollouts, the FDA restricted under-65 eligibility to those with risk factors, aligning with guidance from HHS Secretary Robert… Read more The post Game-Changing Va…

FDA approves mRNA vaccines for new Covid-19 season amid political tension - Pharmaceutical Technology

Moderna and Pfizer/BioNTech have secured formula updates to existing mRNA Covid-19 vaccines.

Moderna receives FDA approval for updated COVID-19 vaccines

Moderna's updated vaccines are expected to be available in the coming days.