FDA Limits Fall 2025 COVID-19 Vaccines to High-Risk Groups Amid Shift Toward Targeted Protection

The U.S. Food and Drug Administration (FDA) has approved COVID-19 vaccines for the fall of 2025, but with significant eligibility restrictions. Only those over age 65, and those aged 5 through 64 with one or more health conditions making them vulnerable to severe illness, will be eligible for the vaccinations.

This is a sharp deviation from previous advice, which stipulated vaccination for all six months and older. The approved vaccines are new technologies from Moderna (6 months+), Pfizer-BioNTech (5 years+), and Novavax (12 years+), which can be given to patients after consultation with the doctors.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) is also expected to comment on the FDA decision and issue new recommendations. Health professionals worry that restricting eligibility will expose vulnerable populations—pregnant women and young children—to the illness.

The shift also comes at a price. Those outside the approved groups might be out-of-pocket by up to $140 per dose if they're not covered by their insurance. The FDA action is part of a broader strategy to prioritize those at highest risk of hospitalization and mortality, with data showing that adults 65 and older account for 70% of COVID-19 hospitalizations and 90% of related deaths in the U.S.

While the 2025–2026 respiratory virus season begins, health officials are urging continued caution such as mask use in public and education on long COVID risks.