The new COVID-19 vaccines for the 2025-2026 season have been approved by the U.S. FDA and are becoming available now, primarily targeting individuals 65 years and older or those aged 12 through 64 with underlying high-risk conditions. Pfizer and Moderna expect their updated vaccines to be available within days at pharmacies, hospitals, and clinics across the U.S., while Novavax's vaccine is expected to arrive in early fall 2025. These vaccines focus on updated virus sublineages closely matching currently circulating strains. However, the FDA restrictions now limit eligibility mainly to higher- risk groups, making access more challenging for healthy younger adults and children without risk factors.
Availability Timeline
- Pfizer and Moderna vaccines: Available within days as of late August 2025, shipping is already underway.
- Novavax vaccine: Expected availability early fall 2025.
Eligibility Criteria
- Adults aged 65 and older.
- Individuals 12-64 years with at least one underlying condition that increases risk for severe COVID-19.
- Some vaccines available to children through consultation with healthcare providers, mostly targeting higher-risk groups.
Vaccine Focus
- The new vaccine formulas target the SARS-CoV-2 sublineages JN.1 and LP.8.1, which are dominant in the current global viral landscape.
- These are monovalent vaccines designed to closely match virus variants expected in the 2025-2026 season.
Access Challenges
- Eligibility has narrowed significantly compared to previous seasons, with healthy younger individuals and children having limited access to the vaccine.
- Healthcare providers and pharmacies across the US are preparing to offer these vaccines soon, but uptake may be complicated by these restrictions.
In summary, the new COVID-19 vaccines for the 2025-2026 season are available now or very soon for most eligible high-risk populations, with a focus on updated strains and restricted eligibility to prioritize those at highest risk.