Fall is upon us, and COVID-19 vaccine guidance is shifting quickly. Below is a concise update to help you stay informed and prepared.

On October 6, 2025, the Centers for Disease Control and Prevention (CDC) announced¹ that the recommendations from the September Advisory Committee on Immunization Practices (ACIP) meeting had been adopted. This capsule has been updated to reflect changes since its original publication on September 12, 2025.

Key Updates:

CDC COVID-19 Vaccine Recommendations:²

• The decision to vaccinate individuals 6 months and older should be based on individual-based decision-making with a healthcare provider, taking into consideration patient characteristics along with risks and benefits of the vaccine
• The benefit of vaccination is greatest for those age 65 and older and for those with underlying medical conditions that increase the risk of severe COVID-19

Coverage Expectations:

• Self-funded and fully insured employers are expected to cover the COVID-19 vaccines at $0 patient cost for eligible members
• Coverage is not expected to be limited by medical indication

Why COVID-19 Vaccines Still Matter

Although COVID-19 infection is no longer classified as a national public health emergency, it continues to pose a significant health burden across the United States. According to the Centers for Disease Control and Prevention (CDC)³:

From October 1, 2024, through August 30, 2025, it is estimated that patients in the U.S. experienced:

• Millions of symptomatic illnesses and outpatient visits
• Between 350,000-510,000 COVID-19 hospitalizations
• Between 39,000-58,000 COVID-19 deaths

As of late August, COVID-19 infections are growing or likely growing in 36 states, with no states showing a decline. To put that in perspective, the CDC estimates that seasonal influenza causes between 6,300 and 52,000 deaths annually in the U.S.⁴ COVID-19 continues to cause a comparable or greater number of deaths, reinforcing the importance of preventive measures, including vaccination—especially in vulnerable populations.

What is Changing?

Food and Drug Administration (FDA) Guidance

The FDA revised its COVID-19 vaccine recommendations⁵ in August 2025 to include:

• COVID-19 vaccine updates (boosters) are supported for:
  • Adults 65 years and older
  • Individuals 6 months and older with conditions that increase the risk for severe COVID-19 infection
• For healthy individuals under 65, future annual shots must show clear benefit through clinical studies. In these cases, shared decision-making between the patient and their healthcare provider is encouraged to determine whether the vaccination is appropriate

In addition to updating vaccine formulations, the FDA has begun rescinding Emergency Use Authorizations (EUAs) for certain COVID-19 vaccines that are no longer needed or replaced by fully approved alternatives. This shift reflects a broader transition from emergency pandemic response to routine vaccine regulation.

The official FDA recommendations have been debated. Physician organizations have issued their own recommendations causing further confusion. For example, the American Academy of Pediatrics announced⁶ different advice, recommending COVID-19 vaccinations for:

• All young children ages 6-23 months
• Older children in certain risk groups based on evidence on who can benefit the most from the vaccine

Centers for Disease Control and Prevention (CDC) Guidance and Immunization Schedule

The CDC updated its COVID-19 vaccine recommendations in October 2025², adopting decisions made during the September 2025 meeting of the Advisory Committee on Immunization Practices (ACIP). These updates reflect a shift from universal vaccination to individual-based decision-making.

Key points include:

• COVID-19 vaccination is no longer universally recommended for all individuals aged 6 months and older
• Instead, vaccination decisions for all age groups should be made through shared individual-based decision-making with a healthcare provider, considering the risks and benefits
• The CDC noted that the benefit of vaccination is greatest for those age 65 and older and for those with underlying medical conditions that increase the risk of severe COVID-19

Access and Coverage Considerations

New Limitations and State Regulations

Prior to the CDC’s announcement, COVID-19 vaccines were available at many pharmacies, however access remained limited. Due to state-level restrictions and unclear federal guidance, some pharmacies were limiting the administration of the COVID-19 vaccine to:

• Individuals who meet FDA-approved guidance
• Those with a prescription from a healthcare provider

Regarding state-level initiatives, on September 3, Florida announced⁷ plans to end school vaccine mandates beyond COVID-19 vaccines, potentially becoming the first state to do so. Other states are forming alliances to pull together their own vaccine recommendations.

The CDC’s October 6 announcement is expected to broaden patient access to the COVID-19 vaccine by clarifying that prescriptions are not required and that individuals 6 months and older may receive the vaccine after consultation with a healthcare provider.

Employer Health Plans

Self-funded and fully insured employers are expected to cover the COVID-19 vaccines for eligible members at no cost to members without limitations on coverage based on medical indication or the requirement provider’s prescription. This clarification was confirmed by America’s Health Insurance Plans (AHIP)⁸, a national trade association representing health insurance providers in the United States, ahead of the CDC’s formal adoption of the ACIP recommendations.

What is ACIP?

The Advisory Committee on Immunization Practices (ACIP) is a Centers for Disease Control and Prevention (CDC) appointed panel of experts that reviews scientific data and literature to make national immunization recommendations for all vaccines, not just COVID-19.⁹ These recommendations influence immunization for children and adults across the U.S.

In early 2025:

• 17 members were dismissed by the U.S. Department of Health and Human Services Secretary, Robert F. Kennedy Jr.
• A smaller panel was appointed, excluding traditional medical liaisons from the American Medical Association (AMA) and other physician organizations that have historically contributed clinical expertise to ACIP’s decision-making.

These changes have raised concerns among infectious disease and vaccine experts about the integrity of future vaccine guidance.

The restructuring has led to increased fragmentation in national vaccine policy as physician organizations and state alliances are developing guidance that may diverge from the CDC and ACIP recommendations. This fragmentation has led to confusion for providers, employers, and the public.

ACIP typically meets three times a year in February, June and October. In 2025, meetings were held in April, and meetings with the revised panel occurred in June and September 2025.

Strategy and Considerations for Employers

Prioritize Health and Safety

• Encourage vaccination for eligible members, especially those at higher risk
• Partner with health plans and PBMs to ensure vaccines are accessible and covered
• Continue providing broad coverage of vaccines at zero-dollar copay to ensure access and accessibility when appropriate

Clarify Coverage Policies and Access Points

• Communicate clearly with employees about where and how they can receive the vaccine
• Ensure your health plan’s coverage policies are up to date and reflect current state and federal guidance

Build Trust Through Transparent Communication

• Share updates on federal and state vaccine recommendations
• Explain how your organization is aligning with public health guidance to protect employees and their families

Prepare for Potential Outbreaks

• Review and update sick leave, remote work and contingency policies
• Consider implementing flexible work arrangements during periods of increased transmission

Monitor Broader Vaccine Guidance

• Stay informed about changes beyond COVID-19, as ACIP is expected to review other vaccine recommendations.
• Our team will provide an update to this communication when more information is made available
• Be aware that physician groups and state coalitions may issue guidance that differs from CDC/ACIP, which could impact coverage and compliance

¹CDC Immunization Schedule Adopts Individual-Based Decision-Making for COVID-19 and Standalone Vaccination for Chickenpox in Toddlers | CDC Newsroom

²Immunization Schedules | Vaccines & Immunizations | CDC

³Preliminary Estimates of COVID-19 Burden for 2024-2025 | COVID-19 | CDC

⁴About Estimated Flu Burden | Flu Burden | CDC

⁵COVID-19 Vaccines (2025-2026 Formula) for Use in the United States Beginning in Fall 2025 | FDA

⁶AAP recommends all young and high-risk children get vaccinated against COVID-19, diverging from CDC policy | AAP News | American Academy of Pediatrics

⁷https://edition.cnn.com/2025/09/03/health/florida-vaccine-mandates

⁸AHIP Statement on Vaccine Coverage – AHIP

⁹Advisory Committee on Immunization Practices (ACIP) | ACIP | CDC

Pharmacy Team