Uncertainty on COVID vaccine access looms ahead of virus season

Normally by this time of year as fall approaches, the FDA has approved new formulas for COVID-19 shots and CDC recommendations on who should receive them have been finalized. 

As this year’s respiratory virus season kicks into gear and COVID cases begin to tick up, guidance on who will have access to the shots is less clear. The CDC’s Advisory Committee on Immunization Practices typically meets in June to vote on who should receive updated vaccines. However, in June, HHS Secretary RFK Jr. overhauled the committee by appointing all new members, several of whom have a history of anti-vaccine rhetoric.

Medical and public health experts have expressed concern that uncertainty surrounding the vaccine landscape could limit uptake and drive up hospitalizations in the months ahead.   

“This usual chain of decisions … has been disrupted,” Katelyn Jetelina, PhD, an epidemiologist who follows respiratory virus trends closely, told Politico in an Aug. 22 report. “And without clarity and coordination, millions may not be able to have clear access to Covid vaccines, and that could potentially impact hospitalizations and deaths.”

Who will be able to get a vaccine — and where?

During the 2024 to 2025 season, the CDC recommended COVID vaccination for everyone 6 months and older. This year, approvals are more targeted, potentially creating hurdles for patients seeking a shot. 

On Aug. 27, the FDA approved Pfizer’s updated COVID vaccine that targets the LP.8.1 strain for use in adults 65 and older, and those who are at high risk for severe illness. The limited approval was expected after the FDA released a new regulatory framework for COVID vaccines in the spring that indicated it would move away from what it described as a “one-size-fits-all” approach. 

In a statement, Pfizer said it will begin shipping doses immediately to pharmacies, hospitals and clinics across the U.S. However, there is still no official recommendation from the CDC’s ACIP committee on who should receive the shot.

Pharmacists — who administered nearly 90% of COVID shots during the 2024 to 2025 season — are now navigating the new rules in effect for 18 states and the District of Columbia, where their authority to administer vaccinations is tied to formal ACIP guidance. Without that recommendation, providers in those jurisdictions may be unable to administer the new shots, even if they have them in stock, according to Politico. 

Some providers might elect to not stock the shots, though, if reimbursement is low or nonexistent.

Many people under age 65 may also need to show proof they have at least one underlying condition — such as asthma, diabetes, cancer, obesity or pregnancy — to receive the vaccine. Healthy individuals who fall outside of FDA criteria could still access the vaccine with an off-label prescription, though availability and willingness to prescribe may vary by provider and state.

With vaccination rates already low, — fewer than 25% of Americans reported receiving a COVID shot during the 2024 to 2025 season — experts worry that any added navigation burdens or confusion could leave more people frustrated and lead them to skip vaccination altogether.

“We’re very concerned that we’ll miss a bunch of patients, and that it will impact vaccine coverage rates,” particularly among older adults who face higher risk of severe outcomes, Brigid Groves, vice president of professional affairs at the American Pharmacists Association, told Politico.  

Will insurers cover them?

It’s likely to be a mixed bag, experts told NBC News. Under federal law, insurers are required to cover vaccines recommended by the CDC’s ACIP with no out-of-pocket costs. But with no formal recommendation in place yet, coverage for those outside the FDA’s limited approval may vary.

People 65 and older or with qualifying health conditions are expected to be covered once the CDC signs off. For everyone else, coverage levels may hinge on their insurance provider. Some plans may still cover the shot in full, while others could require a copay or decline coverage altogether.

The shots can cost up to $140 without insurance, according to CDC data cited by NBC. 

Some insurers may also look to guidance from medical groups to inform coverage decisions, experts told the news outlet. On Aug. 22, the American College of Obstetricians and Gynecologists published clinical guidance reaffirming support for COVID-19 vaccination during pregnancy, breaking with CDC guidance in May that said routine vaccinations were no longer recommended among the population. The move followed a similar decision from the American Academy of Pediatrics, which urged routine vaccination for children as young as 6 months, going further than the CDC’s revised guidance in May that called for shared decision-making between clinicians and families.

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