FDA restricts new COVID shots to vulnerable groups

The Food and Drug Administration has imposed new restrictions on COVID-19 vaccines, making them available only to high-risk groups, a significant departure from previous guidance that advised everyone to be vaccinated universally.

According to Fox News, this development coincides with Health and Human Services Secretary Robert F. Kennedy's plan to conclude vaccine mandates, ensure availability for vulnerable individuals, and withdraw emergency use authorizations.

On Wednesday, Robert F. Kennedy announced the updated authorization via a social media post on X, formerly known as Twitter. The authorized vaccines include Moderna, for ages 6 months and older; Pfizer, for those 5 and above; and Novavax, for individuals aged 12 and up. The targeted high-risk groups consist of older adults over 65 and people with specific health conditions that elevate the danger of severe COVID-19 illness.

Conditions Specified by Health Authorities

The Centers for Disease Control and Prevention (CDC) has listed several medical conditions that could heighten the risk of severe outcomes from COVID-19. Asthma, cancer, heart conditions, cerebrovascular disease, diabetes, dementia, and mood disorders are among these conditions. Additionally, chronic ailments of the lungs, liver, or kidneys, and diseases like Parkinson's are also considered factors.

The recent FDA move involves retracting emergency use authorizations for COVID vaccines, a critical step in Kennedy's outlined goals. As part of his broader plan articulated in May 2025, there was an announcement regarding the removal of COVID-19 vaccines from the CDC’s routine immunization schedule for healthy children and pregnant women. This move marked a crucial pivot from the CDC's earlier stance, which encouraged vaccinations for all individuals over 6 months of age.

The new guidelines underscore the importance of tailored healthcare decisions, adopting what the CDC describes as "shared clinical decision-making." This approach emphasizes the involvement of individual circumstances when deciding on COVID-19 vaccinations, consulting healthcare providers to make informed choices.

Transparency and Vaccine Availability

"I promised 4 things: to end COVID vaccine mandates; to keep vaccines available to people who want them, especially the vulnerable; to demand placebo-controlled trials from companies; to end the emergency," shared Kennedy. He further elaborated that through a sequence of FDA actions, these objectives have been realized.

Kennedy emphasized the availability of the vaccines for all patients wishing to be vaccinated, contingent on consultation with their healthcare providers. "These vaccines are available for all patients who choose them after consulting with their doctors," he stated.

Dr. Marc Siegel, a frequent commentator on healthcare issues, weighed in, supporting the notion of shared decision-making between medical professionals and their patients, especially regarding children. He noted that decisions should be influenced by the individual child’s health status and the prevailing state of COVID-19.

Implications of Regulatory Changes

This regulatory shift means that the previous broad-spectrum recommendation for COVID vaccinations has narrowed significantly, focusing more intently on those in need due to age or underlying health issues. This marks a notable change in strategy, reflecting a more nuanced approach to pandemic management.

Despite the CDC's changes, the American Academy of Pediatrics continues to advocate for COVID-19 vaccines, maintaining their inclusion in its annual immunization schedule. This reflects ongoing debates and differing perspectives on vaccine policy amidst the evolving pandemic landscape.

Public accessibility to vaccines while relying on expert advice aims to reflect what Kennedy describes as the demand from "the American people" for "science, safety, and common sense." He posits that the current framework strikes a beneficial balance between these elements.

While the focus now is on those classified as high-risk, Kennedy reassures the public that vaccines remain accessible for all who, after consulting with their healthcare providers, wish to receive them. He reiterates that the updated policy framework delivers on his commitment to science-based decision-making.

These changes highlight a significant turning point in the administration’s ongoing response to COVID-19. As emergency conditions subside, the efforts focus on devolving responsibilities to individuals and their care providers in making vaccination decisions.