On August 27, 2025, the FDA approved the 2025-2026 formulas of four COVID-19 vaccines and revoked emergency use authorizations (EUAs) for all COVID-19 vaccines. The new limitations for the COVID-19 vaccines mean that individuals less than 65 years of age without an underlying condition that seek a COVID-19 vaccination would need to do so off-label. Pfizer stated it will be shipping its vaccine immediately, and Moderna stated its vaccines will be available within days. Novavax will partner with Sanofi to make its vaccine available sometime this fall.
