STAT+: The unusual Prasad missive in the FDA’s rejection of the Moderna flu shot application

Back to news list

Source: STAT News

Original: https://www.statnews.com/2026/02/11/biotech-news-prasad-missive-fda-moderna-flu-...

Published: Wed, 11 Feb 2026 14:45:15 +0000

The FDA rejected Moderna's flu vaccine application in an unusual report from Prasad. The report is part of the FDA's decision on COVID-19 vaccines for the 2025-2026 season. The FDA withdrew emergency approvals for the COVID-19 vaccines, but approved updated versions from Moderna, Novavax and Pfizer/BioNTech. Modernine's Spikevax and mNexspike vaccines target the LP.8.1 variant and are approved for persons 6 months to 64 years of age with at-risk conditions and all adults over 65 years of age. The Pfizer/BioNTech vaccine is intended for adults over 65 years of age and persons 5-64 years of age with at-risk conditions. Novavax is approved for people 12 years of age and older with at-risk conditions. Vaccines will be available in the next few days.