On Aug. 27, the Food and Drug Administration (FDA) authorized new COVID-19 vaccines from Moderna, Pfizer, and Novavax for 2025-2026 but significantly limited their use. The FDA revoked Emergency Use Authorizations (EUAs) for the Pfizer and Moderna vaccines and narrowed eligibility.
Who is eligible for the updated COVID-19 vaccines?
- Individuals aged 65 and older.
- People under 65 with at least one underlying medical condition (excluding pregnancy) that increases their risk of severe disease. Although “underlying medical condition” appears to be defined broadly, it remains unclear whether individuals must demonstrate that they have underlying conditions.
Who is not eligible?
- Pregnant women
- Healthy adults
- Healthy children
What does the removal of the EUA mean for patients?
Since pregnant women are no longer eligible for the vaccine, newborns are left without coverage from birth to 6 months. Only the Moderna Spikevax is approved for children 6 months and older, but they must have an underlying condition.
Although healthy adults and healthy children under 18 are not eligible for the vaccine, they may still receive one if a physician agrees to prescribe the vaccine off-label. It is unclear whether insurers will cover the vaccines given the changes to the vaccine authorizations.
Will pharmacists be able to provide vaccination to healthy adults without the EUA?
Pharmacists will be able to provide the vaccine in accordance with the labeling (i.e., patients over 65 and those with underlying conditions), although it is unclear whether or how underlying conditions must be documented.
In 19 states, pharmacists’ vaccination is tied to the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) vaccine recommendations. ACIP has not provided recommendations for 2025, but ACIP’s recommendations will impact how the vaccines can be provided and how insurers cover them.
- Other groups, including nongovernmental vaccine advisory groups, such as the Vaccine Integrity Project, may offer recommendations that differ from ACIP’s, potentially complicating coverage decisions.
- Healthy adults may potentially be able to self-pay for the updated COVID19 vaccine since they are ineligible under current FDA criteria, but access is limited and uncertain, requiring a prescriber who is willing to prescribe the vaccine off-label.
ASHP will continue to update members as more information becomes available regarding ACIP recommendations and insurer coverage of vaccinations.
