COVID-19 Vaccination Guidance Changes Amid Policy Shifts

For the first time since the pandemic began, this year’s COVID-19 vaccine rollout looks notably different from previous seasons. While updated shots are broadly available for people 6 months and older, the vaccines aren’t approved for all age groups, and the Centers for Disease Control and Prevention (CDC) now recommends vaccination only after discussion with a healthcare provider.

Health experts emphasize that there has been no meaningful change in vaccine safety or effectiveness. The shots remain safe and provide valuable protection against the coronavirus, with benefits being especially important for high-risk individuals, including older adults, very young children, pregnant people, and those with certain medical conditions.

In a significant departure from past practice, the Food and Drug Administration (FDA) approved this year’s COVID-19 vaccines only for those 65 and older or people with risk factors. According to FDA memos, the head of the vaccines division overruled career staff who had recommended broader approval.

The CDC’s Advisory Committee on Immunization Practices (ACIP) recommended COVID-19 vaccination for everyone 6 months and older, but only after consultation with a healthcare provider—a process known as shared clinical decision-making. This recommendation came after considerable disruption at the agency, including the dismissal of the previous advisory committee in June by Health and Human Services Secretary Robert F. Kennedy Jr., who has made numerous false claims about COVID-19 vaccines.

Amid growing uncertainty about federal guidance, many states and medical organizations have issued their own vaccine recommendations—an unprecedented break with decades of unified public health messaging.

Medical experts widely agree that vaccination is most critical for people 65 and older, pregnant individuals, babies and toddlers between 6 and 23 months, and those with underlying health conditions. Dr. Fiona Havers, an infectious disease physician who formerly led the CDC’s Respiratory Virus Hospitalization Surveillance Network team, notes that hospitalization data clearly shows these groups face the highest risks.

“People age 75 and older have the highest rate of hospitalization,” Havers explained, with those 65-74 showing “very high rates” as well. “At the other extreme, very young children, particularly children under 2, and especially those babies less than 6 months of age, have high hospitalization rates for COVID.”

The 2024-2025 vaccines have demonstrated effectiveness at reducing hospitalization and critical illness in older adults, with data showing the best and most lasting protection against severe outcomes. Vaccination during pregnancy is “really important,” Havers noted, not only to protect the mother but also because antibodies pass to the baby, providing protection for infants too young to be vaccinated.

Several medical organizations have issued clearer guidance than the federal government. The American College of Obstetricians and Gynecologists continues to recommend COVID-19 vaccination for all pregnant and lactating individuals. The American Academy of Pediatrics recommends vaccination for children 6-23 months and older children in high-risk groups. The American Academy of Family Physicians recommends COVID-19 vaccination for all adults, emphasizing its importance for high-risk individuals.

Four updated vaccine formulations are available this season: Moderna’s Spikevax and mNEXSPIKE, Pfizer/BioNTech’s Comirnaty, and Novavax’s Nuvaxovid. These shots target current circulating variants, primarily LP.8.1 and related subvariants in the JN.1 lineage. A new addition this year is Moderna’s mNEXSPIKE, which uses a lower dose of mRNA while maintaining similar efficacy.

Under the CDC’s shared clinical decision-making recommendation, insurance should cover the vaccines at no cost for most people. The Vaccines for Children program continues to provide free recommended vaccines to eligible children who are uninsured, underinsured, Medicaid-eligible, or American Indian/Alaska Native.

However, experts worry that the confusing guidance may create access barriers. “Health care providers tend to dislike such broad recommendations for shared clinical decision-making because it gives them no guidance and nothing clear to follow,” Havers said. Young children may be particularly affected, as many pediatricians waited for CDC guidance before ordering doses, and pharmacies face restrictions on vaccinating the smallest children.

The mixed messages from federal agencies, combined with a lack of government advertising campaigns promoting vaccination, has created an environment of uncertainty. Jennifer Kates, senior vice president at KFF, summarized the situation: “There’s confusion around what the federal government is recommending, and there’s increased vaccine skepticism writ large. That is likely going to dampen vaccine rates.”