FDA Narrows Approval for COVID Vaccines
(Sept. 2, 2025) The Food and Drug Administration (FDA) approved updated COVID vaccines on Aug. 27th with new limitations. COVID vaccines are now approved for individuals aged 65 years or older, or those under age 65 who are at risk for serious complications related to COVID infection. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) reportedly made similar recommendations that were not approved by then-CDC Director Susan Monarez and therefore are not officially endorsed by the CDC at this time. While Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. maintains that COVID vaccines will remain available for those who want them, the new limitations are likely to pose barriers to non-qualifying individuals, such as health care personnel and other staff in LeadingAge communities for whom the vaccines may not be covered by insurance and no “bridge” program exists. Previously, the CDC operated the Bridge Access Program that provided free COVID vaccines to uninsured and underinsured individuals; however, this program ended in August 2024. No similar program was available for the 2024/2025 respiratory virus season, and HHS has not indicated any plans for a program during the 2025/2026 respiratory virus season that will begin in October.
Nursing homes and adult care facilities (ACFs) are required by regulation to offer or make available the vaccine to residents and staff.
Regulatory Requirements for Facilities:
- Nursing homes must ensure vaccination opportunities for new admissions, readmissions, and new hires within 14 days.
- Facilities must post visible signage about vaccine availability.
- If a resident or staff member declines vaccination, they must sign a written affirmation acknowledging the offer and their responsibility to request it later if they change their mind.
- Facilities are also encouraged to offer flu and respiratory syncytial virus (RSV) vaccines alongside COVID shots.
Some members of staff may not qualify for the vaccine based on the FDA determination. LeadingAge NY is reaching out to LeadingAge National and the Department of Health (DOH) to determine how to comply with the regulations consistent with this policy decision.
Contact: Amy Nelson, anelson@leadingageny.org, 518-867-8383 ext. 146