The Food and Drug Administration approved COVID-19 vaccine doses for the fall and winter season on Wednesday — but with limitations that will likely hinder access for millions of people.

The agency granted approval for COVID-19 vaccine doses for people over age 65, who are most vulnerable to severe infections, but younger people will only be eligible if they have at least one underlying medical condition that puts them at higher risk for hospitalization or death. Younger people without such conditions could have trouble getting the shot.

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Health and Human Services Secretary Robert F. Kennedy Jr. posted on X that the FDA rescinded the emergency use authorizations for three COVID-19 vaccines, from Moderna, Pfizer, and Novavax, and replaced them with marketing authorizations.

“The American people demanded science, safety, and common sense. This framework delivers all three,” Kennedy said.

The FDA’s new age and risk factor parameters were previewed in May in an essay in the New England Journal of Medicine written by FDA Commissioner Dr. Marty Makary and the agency’s vaccine chief, Vinay Prasad. 

The list of risk factors in the May policy announcement included 23 categories of conditions, including obesity, Type 2 diabetes, and heart conditions. Some of the categories listed are very broad, including mood disorders such as depression and “physical inactivity.”

Children under 18 without any of those increased risk factors will still be able to receive the vaccine following consultation with a physician, according to sources familiar with the policy change who spoke with the New York Times.

The HHS did not respond to the Washington Examiner’s request for comment. 

Per Kennedy’s X statement, the FDA issued full marketing authorization for the Moderna vaccine for people over age 6 months, the Pfizer vaccine for people over age 5 years, and the Novavax vaccine for people over age 12.

Moderna’s and Pfizer’s vaccines use mRNA technology, the safety of which Kennedy and other leading public health officials in the Trump administration have questioned. The Novavax vaccine uses a more traditional, protein-based formula.

A Pfizer press release following the announcement said the FDA approval “is based on the cumulative body of evidence supporting the safety and efficacy” of their product, including for children between the ages of 5 and 11. 

“To date, 5 billion doses have been distributed globally of the Pfizer-BioNTech COVID-19 vaccine, which continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as by clinical, non-clinical, pharmacovigilance, and manufacturing data,” the press release said.

Moderna CEO Stephane Bancel said in a press release accompanying the news that “protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health as COVID-19 was responsible for up to 4 million outpatient visits and nearly half of a million hospitalizations last year.”

Public health advocates supportive of vaccination have expressed growing concerns in recent months that decisions from the Kennedy administration will hinder access to COVID-19 vaccines by making them less likely to be covered by insurance.

Insurers usually base their coverage decisions on recommendations from an advisory panel from the Centers for Disease Control and Prevention. This summer, Kennedy dissolved that panel and replaced it with scientists and medical professionals who are skeptical of vaccines, including for COVID-19. 

Kennedy said in his X post that the policy would “keep vaccines available to people who want them, especially the vulnerable.”

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Several medical professional organizations, including the American Academy of Pediatrics and the American College of Cardiologists, issued their own guidelines with respect to COVID-19 vaccines. 

The AAP recommends that young children between the ages of 6 and 23 months receive a COVID-19 vaccine for the upcoming season, considering they are at higher risk for severe disease. The ACC also recommends that patients with cardiovascular disease receive a COVID-19 vaccine this fall.