COVID-19 Vaccines in 2025: New Regulatory Guidelines

Summary: Due to recent federal changes, COVID-19 vaccine access rules now vary by state, with prescriptions required in several states. Employers should prepare for varying access and future supply challenges. Key considerations for employers sponsoring group health plans include:

• Self-funded group health plans: Consider direct purchasing and seamless telehealth e-Rx.
• Fully insured group health plans: Confirm coverage and push for proactive communication.

Read on for more information regarding these recent changes and what to expect next.

As the U.S. moves into the 2025–2026 season, the policy landscape around COVID-19 vaccine recommendations is shifting. For much of the COVID-19 pandemic, federal emergency authority simplified access and ensured that employees could walk into a pharmacy and receive a vaccine without barriers. That framework has now changed. This post explains how new rules may impact employee access, coverage, and potential costs for both self-funded and fully insured group health plans.

Major Shift: Federal to State Authority

During the height of COVID-19, the federal government invoked the Public Readiness and Emergency Preparedness (PREP) Act. One of its key provisions granted pharmacists across the country the authority to administer COVID-19 vaccines to children and adults without a prescription. This measure was designed to maximize convenience, reduce bottlenecks, and make vaccines available in as many locations as possible.

That authority expired in 2024. In August 2025, the Food and Drug Administration (FDA) also narrowed the vaccine’s authorization, and revoked broad emergency use authorization. The updated vaccine is now authorized primarily for:

• Adults 65 and older, and
• Individuals six months and older with qualifying underlying conditions.

With these changes, states now have primary jurisdiction over who can prescribe and administer vaccines. Some states already had permanent laws empowering pharmacists to vaccinate adults with FDA-approved products, while others required standing orders from physicians or collaborative practice agreements. Without the federal umbrella, these differences now shape access state by state.

This is more than a technicality. In practice, it means that in certain states, employees can still walk into a pharmacy and receive the updated COVID-19 shot. In others, they must first secure a prescription from a healthcare provider. Beginning in September 2025, CVS indicated that a prescription would be required in select states, but the situation is changing rapidly. We found that at least some of those states have since issued standing orders, removing prescription requirements within their jurisdictions for all ages.

The Patchwork Effect of State Jurisdiction

The re-emergence of state control has created a patchwork system impacting both employers and employees. As of September 20, 2025, based on our analysis of states’ rules:

• 39 states allow direct pharmacist authority: Employees can access vaccines as they did during the pandemic. No prescription, no delay.
• Seven states and DC are following federal recommendations: Employees must secure a prescription before getting vaccinated (Florida, Georgia, Kentucky, Louisiana, Nevada, Utah, West Virginia, and DC).
• Four states remain unclear: Rules are ambiguous, and pharmacies may make different decisions without additional clarity from the state (Oregon, North Carolina, Virginia, Pennsylvania).

This inconsistency means that a workforce spread across multiple states will face varying access, depending on where employees live. Employers with multistate operations need to prepare for potential uneven vaccination access rates and employee confusion, which can affect absenteeism, productivity, and employee perceptions.

Self-funded employer plan sponsors operating in states with prescription-only access who want to simplify access for their employees and their families may consider:

• Prescription pathways: Working with health plan carriers on setting up pathways for employees to obtain prescriptions quickly (e.g., integrated telehealth services or app-based “e-Rx” systems).
• Direct contracting: Exploring mechanisms to directly contract with pharmacies or pooled procurement models to secure vaccine supply.

Fully insured employer plan sponsors might generally have fewer tools available, but they also can take steps to improve access for their employees, including:

• Coverage verification: Confirming whether the carrier will cover vaccines without prescriptions in states where pharmacists have authority, and what the process will look like in prescription-only states.
• Proactive communication: Asking carriers to provide employees with state-specific guidance on qualifying conditions, access, prescription process, eligible sites, and any out-of-pocket cost implications.
• Alternative options: They could also consider alternative, more involved options such as direct purchasing or reimbursing out-of-pocket expenses to employees. 

Recent Advisory Committee on Immunization Practices (ACIP) Meeting

On September 19, 2025, the ACIP met to update its federal recommendations for COVID-19 vaccination. The outcome left much of the ambiguity in place:

• No prescription requirement: A proposal to mandate prescriptions for adults under 65 failed. ACIP did not require prescriptions, leaving that decision to states.
• No coverage mandate: ACIP also did not require that health plans cover the vaccine for younger, healthy adults without a prescription. Instead, they adopted a “shared clinical decision-making” approach, emphasizing vaccination for older adults and those with risk factors.
• No clear national guidance: ACIP’s actions mean there are no clear national standards for COVID-19 vaccine access for those under 65. The absence of clear national guidance means that states remain the key decision-makers. Where governors or health departments have issued statewide standing orders, pharmacists can administer COVID-19 vaccines without individual prescriptions, and insurers have a clear basis to cover those claims. In states without such orders, ambiguity persists — pharmacies may continue requiring prescriptions and insurers may restrict or deny coverage for younger populations.

Looking Ahead: 2026 and Beyond

While the 2025–2026 season is unlikely to see major supply shortages, the longer-term outlook could be more challenging. In August 2025, the Department of Health and Human Services announced plans to end federal funding for mRNA vaccine development projects, cutting nearly 500 million dollars in support. This will likely reduce the number of updated vaccines available in future seasons. Combined with narrower FDA authorizations and uneven state rules, the U.S. may face limited supply and higher costs by 2026–2027.

For employer group health plan sponsors, this underscores the importance of planning ahead:

• Forecasting needs: Estimating vaccine demand within employee populations early.
• Leveraging Pharmacy Benefit Managers (PBMs): Working with PBMs to coordinate procurement and negotiate discounts.
• Pooling demand: Exploring collaborations with other employers or industry groups to secure favorable pricing.
• Investing in communication: Ensuring employees are informed about evolving rules and how to access vaccines in their state.

Concluding Thoughts

The U.S. is entering a new era of COVID-19 vaccine policy: federal direction has receded, and state rules now drive access. With ACIP stopping short of clear mandates, employers must prepare for uneven coverage and operational uncertainty in the near term, while also planning for potential supply and cost pressures in future seasons.

For group health plan sponsors, the focus should be on:

• Monitoring state developments: Tracking where standing orders remove prescription barriers and where they do not.
• Clarifying coverage: Ensuring carriers or PBMs commit to covering vaccines in line with state authority.
• Supporting employees: Providing clear, state-specific communication and streamlined pathways to access vaccines.

Employers that anticipate these shifts and plan proactively may be better positioned to protect their workforce and manage costs, even as the policy environment continues to evolve.

Risk Strategies Consulting can help your organization evaluate the right tools and partners to create a better experience for your employees. Learn more about Risk Strategies Consulting here.