The Food and Drug Administration on Thursday approved COVID-19 vaccines for the 2026-27 season for people at higher risk of severe illness, including everyone 65 and older and younger people with certain underlying health conditions.
The FDA approved Moderna’s vaccine for people ages 6 months and older, Pfizer’s for those ages 5 and older, and Sanofi’s for people ages 12 and older. The agency also approved a lower-dose Moderna vaccine, mNEXSPIKE, for people ages 12 and up.
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The FDA estimated last year that between 30% and 60% of Americans have a condition that could qualify them for vaccination. Qualifying conditions include asthma, diabetes, obesity, physical inactivity, and pregnancy, as well as cancer, immune deficiencies, certain mental illnesses, and various heart and lung diseases.
The approvals come as COVID-19 infections are increasing or likely to increase in most states. As of Aug. 19, the Centers for Disease Control and Prevention estimated that infections were growing or likely growing in 47 states, declining or likely declining in none, and stable in two. Despite the increase, the overall spread of the virus remains low.
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People who do not formally meet the FDA’s eligibility criteria may still be able to receive a COVID-19 vaccine. Doctors can administer vaccines off-label, meaning outside the specific uses authorized by the FDA. However, access may vary because most Americans receive COVID-19 vaccines at pharmacies rather than doctors’ offices, and pharmacists in some states may be unable or unwilling to administer vaccines off-label.
The CDC’s advisory panel was expected to make recommendations on who should receive the updated vaccines. But a federal court recently invalidated the appointments of all new panel members made by Health Secretary Robert F. Kennedy Jr.
