Updates on 2025–26 COVID-19 Vaccines

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Updates on 2025–26 COVID-19 Vaccines

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September 5, 2025


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Updates on 2025–26 COVID-19 Vaccines

The U.S. Food and Drug Administration (FDA) approved the 2025–26 COVID-19 vaccines on Aug. 27. Each vaccine is licensed with specific age and risk group indications:

2025-26 COVID-19 vaccines

FDA authorizes and licenses vaccines based on safety and effectiveness, while the Advisory Committee on Immunization Practices (ACIP) develops recommendations on how those vaccines should be used in the population. ACIP recommendations for COVID-19 vaccine are pending. The next meeting is scheduled for Sept. 18 and 19, and more information is available on Meeting of the Advisory Committee on Immunization Practices: 2025-16706 (PDF). Vaccine availability through the Minnesota Vaccines for Children (MnVFC) program is dependent on ACIP recommendations.

Recommendations and guidance

The Minnesota Department of Health (MDH) is committed to sharing evidence-based information about vaccines. Below are several resources from professional organizations that have reviewed the best available scientific evidence and developed recommendations for vaccination. Providers can use these resources as they vaccinate.  

The University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) reviewed nearly 600 studies and found that COVID-19, influenza, and respiratory syncytial virus (RSV) vaccines remain safe and effective for children, immunocompromised populations, and during pregnancy. Learn more at CIDRAP: Vaccine Integrity Project. Several professional organizations have used this analysis to develop evidence-based recommendations. MDH aligns with existing evidence-based guidance from independent experts and national professional organizations including the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG).

Pediatric COVID-19 vaccination

AAP recommends COVID-19 vaccination for children on AAP-Immunization-Schedule (PDF), with emphasis on those most at risk:

  • Children 6 through 23 months of age: AAP recommends all young children in this age group be vaccinated with a 2025–26 COVID-19 vaccine formula, regardless of prior vaccination or infection history. COVID-19 hospitalization rates in this group are the highest among pediatric populations, and comparable to adults 50–64 years of age. Notably, more than half of young children hospitalized had no underlying condition.
  • Children 2 through 18 years of age: AAP recommends one dose of an age-appropriate COVID-19 vaccine for those who are at high risk for severe COVID-19, live in long-term care or congregate settings, have never been vaccinated, or live with household members at high risk. Vaccination should also be offered to children outside these groups if parents or guardians request protection.

Adult COVID-19 vaccination

The updated COVID-19 vaccines are licensed for adults 65 years and older and for adults of any age with medical conditions that increase the risk of severe illness. ACOG continues to recommend that all people who are pregnant or lactating receive an updated COVID-19 vaccine based on strong evidence of safety and protection against severe disease for parent and baby. For more information refer to ACOG: COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care.

Legal considerations

Physicians may legally prescribe or administer FDA-approved vaccines off-label, just as they can with other FDA-approved drugs and biologics. If you are considering offering the COVID-19 vaccine outside of the FDA-approved labeling (often called “off-label”), we recommend first consulting with your organization’s legal counsel.

The Minnesota Board of Pharmacy has determined that pharmacists may prescribe and administer COVID-19 vaccine in accordance with official FDA product labeling.


Availability in Minnesota

Some locations are already offering updated 2025-26 COVID-19 vaccines. Typically, we see availability increase throughout the fall season as more sites receive vaccine shipments.


What You Can Do Now

  • Plan within your organization: Review the Fall 2025 Respiratory Vaccine Planning Toolkit for Providers (PDF) to support clinic operations and patient outreach.
  • Check supply and staffing: Ensure your clinic is ready to administer COVID-19, flu, and RSV vaccines this season.
  • Prioritize high-risk patients: Proactively reach out to adults 65 years of age and older, families with children under 2 years, and others at higher risk for severe illness.
  • Stay current: Review recommendations from AAP, ACOG, and other national professional organizations.
  • Consult legal representation about off-label usage: If your clinic is considering offering COVID-19 vaccine outside FDA-licensed indications, consult your organization’s legal representative before proceeding.
  • Promote consistency: Share MDH updates with your networks to help patients receive clear, evidence-based information.

Vaccination continues to be one of the most effective tools for protecting people of all ages from serious disease. MDH will continue to support evidence-based recommendations, access to vaccines, and policies that prevent dangerous diseases.