New authorization limits shots to adults ≥65 and individuals with underlying health conditions, with ACIP set to review guidance and insurance coverage implications.
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The US Food and Drug Administration (FDA) has authorized updated COVID-19 vaccines for fall 2025, limiting eligibility to adults aged ≥65 years and individuals with at least one underlying medical condition that increases risk of severe illness.1
The authorization, announced August 27, 2025, by Health and Human Services Secretary Robert F Kennedy Jr, applies to vaccines from Moderna (≥6 months), Pfizer-BioNTech (≥5 years), and Novavax (≥12 years). Kennedy stated that the vaccines are available for patients “who choose them after consulting with their doctors.” The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will next review the FDA decision and issue updated vaccination recommendations. Previous guidance had recommended vaccination for all individuals ≥6 months.1
The FDA’s decision reflects a broader shift toward prioritizing high-risk populations for vaccination. Still, some public health leaders caution against narrowing eligibility too far. Robert H Hopkins, Jr, MD, medical director of the National Foundation for Infectious Diseases (NFID), told Contagion, “The NFID is concerned about the recent FDA announcement approving COVID-19 vaccines with new restrictions. As a physician, I know firsthand that COVID-19 vaccines save lives by helping to prevent serious illness, hospitalization, and death. While vaccination is especially critical for those at higher risk—such as older adults and individuals with chronic health conditions—COVID-19 can also have severe consequences for young children, pregnant women, and otherwise healthy adults. COVID-19 vaccines have undergone rigorous testing and continue to be closely monitored for safety and effectiveness. Vaccination is the best way to protect individuals and communities from COVID-19.”
The new restrictions may affect insurance coverage for those outside the designated high-risk groups. According to CDC’s vaccine price list, a COVID-19 dose without insurance may cost up to $140. This decision reflects an ongoing shift toward targeted vaccination strategies, with ACIP emphasizing prioritization of populations at highest risk of hospitalization and death.emphasizing prioritization of populations at greatest risk for hospitalization and death.1
FDA approved updated fall 2025 COVID-19 vaccines only for adults ≥65 and those with at least one high-risk medical condition.
CDC’s ACIP will review the FDA decision and issue recommendations for use.
New restrictions may affect insurance coverage; without it, a dose could cost up to $140.
Back in May 2025, the FDA approved Moderna’s new COVID-19 vaccine, mRNA-1283 (mNEXSPIKE), for adults aged ≥65 and for individuals 12–64 with at least one CDC-defined underlying risk factor. In a phase 3 trial of more than 11,000 participants, the vaccine showed 9.3% higher overall efficacy than the original Spikevax and 13.5% higher efficacy in adults ≥65, with a favorable safety profile and fewer local reactions. Moderna expects the vaccine to be available for the 2025–2026 respiratory virus season.2
To better understand the clinical impact, Contagion spoke with Juanita Mora, MD, an allergist and immunologist in Chicago who serves largely Latino and African American communities. She emphasized the importance of vaccination and additional precautions for older adults. “We know it affects the 65 and older population, and it hits them hard,” Mora said, noting that this group accounts for 70% of hospitalizations and 90% of deaths from COVID-19 in the US. She urged masking in crowded spaces, continued vaccination campaigns, and education on long COVID risks.3
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