FDA Will No Longer Approve Annual COVID Vaccine For Younger, Healthy Patients

In a major policy shift, the FDA has announced it will no longer approve annual COVID-19 vaccines for healthy children and adults under 65. Going forward, yearly boosters will be reserved primarily for seniors and individuals with underlying health conditions, marking a significant rollback of the universal vaccination approach used during the pandemic.

According to FDA officials, the updated guidance reflects evolving data showing that the benefit of routine boosters for low-risk individuals is minimal. In contrast, evidence continues to support annual vaccination for those over 65 and others with elevated medical risk—such as individuals with diabetes, heart disease, cancer, or weakened immune systems.

“The science doesn’t support giving healthy 25-year-olds a shot every year,” one senior FDA official said. “We’re narrowing the focus to where the data clearly show a benefit: older adults and high-risk groups.”

Pharmaceutical companies like Pfizer and Moderna will now be required to present new, robust clinical trial data before the FDA considers approving updated annual boosters for younger populations. These trials will need to demonstrate that boosters significantly reduce serious illness, hospitalizations, or deaths in otherwise healthy individuals—something existing data has yet to clearly establish.

The decision also brings U.S. policy more in line with other countries, including the UK, Canada, and Australia, which have already scaled back COVID booster recommendations for younger, healthy people.

While many experts are applauding the move as a long-overdue return to science-based policy, others have expressed concern. Some pediatricians and public health officials warn the decision may limit vaccine access for families who still wish to boost younger children, especially those living with high-risk relatives. There are also concerns that reduced eligibility could impact insurance coverage or reimbursement for those seeking the vaccine.

The FDA’s vaccine advisory committee is set to meet on May 22 to determine which variants should be targeted in the next round of COVID shots. The agency will finalize approvals for fall boosters later this year, and under the new framework, those doses will likely be limited to the most vulnerable segments of the population.

This shift signals a new phase in the nation’s approach to COVID-19—one that emphasizes targeted protection over blanket measures, and brings pandemic policy into closer alignment with long-term risk-based strategies.