Federal Officials Consider Narrowing COVID Vaccine Recommendations Amid New Regulatory Hurdles

Federal health agencies are considering significant changes to how COVID-19 vaccines are recommended and distributed in the United States, a shift that could result in fewer Americans being advised to receive the shots this fall, the New York Times reports.

Under proposed changes, only older adults and individuals with chronic health conditions may be encouraged to get vaccinated — contingent on the vaccines being available at all.

This possible move reflects ongoing discussions among scientific advisers to the Centers for Disease Control and Prevention (CDC), who have debated whether to continue recommending the COVID-19 vaccine for all individuals aged 6 months and older, or to adopt a risk-based approach focused on the most vulnerable groups. A final decision is expected in June.

However, new federal testing requirements may further complicate this year’s vaccine rollout. The Department of Health and Human Services (HHS) recently stated that updated versions of vaccines — including those revised annually to address new viral strains — may now be categorized as “new products”, potentially subjecting them to additional clinical testing. This change could delay or even limit the availability of COVID-19 and flu shots for the upcoming season.

“This may include seasonal updates to COVID vaccines and possibly the flu vaccine,” said HHS spokesperson Andrew Nixon.

The Food and Drug Administration (FDA) has already asked vaccine manufacturer Novavax to provide more data before granting full approval for its COVID-19 shot, which currently has emergency use authorization for people aged 12 and older.

“We want to ensure that vaccines remain available for high-risk individuals,” said FDA Commissioner Dr. Marty Makary. “At the same time, we’re seeking stronger clinical data to support their use.”

Concerns about pediatric vaccinations have also emerged. According to an anonymous official, federal agencies have asked CDC scientists for updated data on COVID-related deaths in children under 12, potentially indicating a reconsideration of vaccine use in that age group. The Wall Street Journal reported that HHS is considering ending recommendations for COVID shots in children and pregnant women.

Some public health experts say the data supports continuing vaccinations for high-risk populations, particularly those aged 75 and older, who continue to account for the majority of COVID-19 deaths.

“There are still more COVID deaths than we’d like,” said Dr. Philip Krause, a former FDA vaccine regulator. “Some groups clearly benefit from the vaccine.”

Others are concerned that the broader implications of the changes may lead to reduced access to routine vaccinations. Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, warned that the federal changes could signal a broader erosion of vaccine policy and infrastructure.

“We’re watching the vaccine system being dismantled bit by bit,” he said.

Insurance coverage could also be affected. In the U.S., insurance providers are not required to cover vaccines that are not explicitly recommended by the CDC, raising concerns that some individuals who would benefit from the shot may not be able to afford it under a risk-based approach.

“There are equity concerns,” said Dr. Denise Jamieson, a CDC adviser. “Vaccinations for unvaccinated children and those with risk factors are critically important.”

CDC advisers remain divided. While some agree that broad recommendations may no longer be necessary, others caution against narrowing eligibility too drastically — particularly for children, who may still face hospitalization despite overall lower fatality rates.

Dr. Sean O’Leary of the American Academy of Pediatrics emphasized the importance of pediatric access:

“If the vaccine were withdrawn for young children entirely, I would have a big problem with that.”

As of now, the FDA has not provided specific details on the scope or timeline of the new clinical testing requirements. Experts note that conducting placebo trials may no longer be ethical, and results from any new studies would not be available before fall.

The current uncertainty underscores a broader debate over the future of COVID-19 vaccination in the US, where decisions may increasingly depend on scientific, regulatory, and political factors. Whether the CDC’s advisers retain influence in shaping national policy remains unclear, particularly amid delays in acting on their most recent vaccine recommendations.

The CDC does not currently have a permanent director, and recent internal communications show ongoing scrutiny of the agency’s decisions by officials at HHS.