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# FDA Approves Moderna Covid Vaccine sBLA
- URL: https://www.fdaweb.com/fda-approves-moderna-covid-vaccine-sbla/
- Published: 2025-07-10T12:00:00.000Z
- Updated: 2026-09-14T15:16:16.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159487

FDA has approved a Moderna sBLA for Spikevax, the company’s Covid-19 vaccine, in children aged six months through 11 years who are at increased risk for Covid-19 disease. A company [statement](https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx?ref=fdaweb.com) says the FDA full approval replaces the previous emergency use authorization.