Updated COVID-19 Vaccines Now Available Amid Changed Guidance and Potential Access Challenges

For the third consecutive fall since 2022, updated COVID-19 vaccines are now available for Americans aged 6 months and older. However, this year marks a significant shift in how the vaccines are being approved and recommended, potentially creating confusion for both healthcare providers and the public.

Unlike previous years, the Food and Drug Administration (FDA) has approved the 2024-2025 COVID-19 vaccines only for those 65 and older or individuals with specific risk factors. This decision came after the FDA’s head of vaccines overruled career staff who had recommended broader approval, according to agency memos.

The Centers for Disease Control and Prevention (CDC) has taken an unusual approach by recommending the vaccines for all ages 6 months and up, but only after consultation with a healthcare provider – a process known as shared clinical decision-making. This recommendation, which is broader than the FDA approval, creates a situation where most people who want the vaccine can receive it, though possibly with additional hurdles.

“In practice, recommending the vaccines under shared clinical decision-making largely affirms that people considering vaccination should have an opportunity to discuss any questions about the vaccine with a healthcare provider before making their final decision,” explained Jason Schwartz, a professor at the Yale School of Public Health specializing in vaccine policy.

The unusual approach to this year’s recommendations follows significant changes at federal health agencies. In June, Health and Human Services Secretary Robert F. Kennedy Jr. dismissed the CDC’s Advisory Committee on Immunization Practices (ACIP) and installed new members. The CDC director was later fired in August, with other top officials resigning in the aftermath.

When the reconstituted ACIP finally met in September, it did not complete its normal procedure of gathering and presenting evidence behind its recommendations. Some members made what experts have characterized as misleading claims about vaccine safety, despite no new safety concerns emerging in the data.

Dr. Fiona Havers, who formerly led the CDC’s Respiratory Virus Hospitalization Surveillance Network team before resigning in June, expressed concern about the new approach. “Healthcare providers tend to dislike such broad recommendations for shared clinical decision-making because it gives them no guidance and nothing clear to follow,” she said.

Experts broadly agree that vaccination remains most important for specific high-risk groups: people 65 and older, pregnant individuals, babies and toddlers aged 6-23 months, and those with underlying health conditions that increase their risk of severe COVID-19.

Data presented at the September ACIP meeting showed that the 2024-2025 vaccines reduced the risk of hospitalization and critical illness in adults 65 and older. For children and adults more generally, additional vaccine doses also lowered the rate of urgent care and emergency room visits.

Four updated COVID-19 vaccines are available this season: Spikevax and mNEXSPIKE from Moderna, Comirnaty from Pfizer/BioNTech, and Nuvaxovid from Novavax. The mRNA vaccines (Spikevax, mNEXSPIKE, and Comirnaty) target the spike protein from the LP.8.1 subvariant, while Nuvaxovid targets the JN.1 variant.

For most Americans with health insurance, the vaccines should remain available at no out-of-pocket cost through pharmacies or doctors’ offices, assuming a healthcare provider determines vaccination is appropriate. The Vaccines for Children program continues to offer free recommended vaccines to eligible children who are uninsured, underinsured, Medicaid-eligible, or American Indian/Alaska Native.

However, experts worry the complex approval and recommendation process could create access barriers. Finding providers with pediatric doses in stock may prove challenging, especially for very young children. Some pediatricians were waiting for CDC guidance before ordering doses, and others may opt not to stock them if demand appears low.

Adding to the confusion, states and medical organizations have begun issuing their own guidance that sometimes differs from federal recommendations – an unprecedented development in recent vaccine policy. According to a September review by health policy research group KFF, 22 states specifically identify non-federal entities as sources for their vaccine recommendations.

“There’s confusion around what the federal government is recommending, and there’s increased vaccine skepticism writ large,” said Jennifer Kates, senior vice president at KFF. “That is likely going to dampen vaccine rates.”

The absence of government advertising and media campaigns to encourage COVID-19 vaccination this year has also been noted by public health experts as a potential contributor to lower uptake rates.

As winter approaches – historically the season of peak COVID-19 transmission – experts suggest now is an appropriate time for eligible individuals to consider vaccination, particularly those at highest risk of severe outcomes.