FDA Narrows COVID-19 Vaccine Approvals and Ends EUAs in Advance of ACIP Meeting Later This Month

This article was exclusively distributed to subscribers on September 8, 2025. Click to receive additional information about how to subscribe and to activate a complimentary trial subscription.

On August 27, the Food and Drug Administration (FDA) licensed 2025–2026 versions of the COVID-19 vaccines for individuals age 65 and older and those aged 5 to 64 with at least one underlying condition that puts them at risk for severe COVID-19 outcomes. At the same time, FDA rescinded the emergency use authorizations (EUAs) for COVID-19 vaccinations in other populations. In so doing, the FDA shifted its approach to COVID-19 vaccination from broad, age-based access to a risk-stratified model. 

The FDA’s announcements occurred the same day that Centers for Disease Control and Prevention (CDC) Director Susan Monarez was from her position less than a month after her Senate confirmation. Monarez’s resignation spurred a domino effect as several other top CDC officials submitted their resignations, including the CDC’s chief science and medical officer; the director of the National Center for Immunization and Respiratory Diseases; the director of the Office of Public Health Data, Surveillance and Technology; and the director of the National Center for Emerging and Zoonotic Infectious Diseases. Subsequently, Department of Health and Human Services (HHS) Deputy Secretary Jim O’Neill assumed the role of acting CDC director. O’Neill says he is “pro-vaccine” but is a close ally of Secretary Kennedy’s.

The FDA action does not mean the COVID-19 vaccine will be unavailable to healthy people below age 65, but it could make access more challenging for that population because the ability of pharmacists to prescribe or dispense vaccines could be limited to their FDA labeling in some states. Physicians can generally order or administer vaccinations for patients “off label” if they determine doing so is appropriate. FDA labeling is not the most important factor in whether health plans will provide coverage for COVID-19 vaccine. Instead, employment-based plans, individual market plans, and some Medicaid plans are required to cover vaccines recommended by the CDC and its Advisory Committee on Immunization Practices (ACIP), which have not yet made recommendations for the 2025-2026 season. Some health plans may continue to provide coverage, irrespective of the CDC recommendation.

In response, states have taken divergent actions. On September 3, governors a tri-state “health alliance” between California, Oregon, and Washington to jointly evaluate evidence and align vaccine guidance for COVID-19, influenza, and routine childhood immunizations, positioning the effort as a science-forward counterweight amid CDC leadership turmoil. In contrast, Florida it will move to eliminate all vaccine mandates, including school-entry requirements. For providers, manufacturers and payors, a state-based framework could create a parallel layer of recommendations this season, with unresolved practical questions such as whether plans will cover vaccines endorsed by states but not by CDC or ACIP, how pharmacies and primary care practices should navigate protocols and liability, and whether school or workplace requirements will continue to track CDC schedules if state guidance diverges.

The CDC has scheduled ACIP’s next public meeting for September 18–19 (virtual), with oral public comment. Given the August 27 COVID-19 vaccine decision and subsequent response from states compounded by the fallout from Monarez’s termination, stakeholders will be closely watching for committee discussion and any votes that will shape implementation, payor coverage, and clinical guidance in advance of the upcoming fall respiratory illness season.

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