The Food and Drug Administration approved the next round of Covid shots for the fall — but only for a smaller, high-risk group of people, Health and Human Services Secretary Robert F. Kennedy Jr. said Wednesday.
The updated Covid shots are approved for adults 65 and older as well as for kids and adults with at least one medical condition that puts them at risk of severe illness.
Kennedy announced the approval in a post on X.
“FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+),” Kennedy wrote. “These vaccines are available for all patients who choose them after consulting with their doctors.”
Kennedy also said that emergency use authorizations for the vaccines had been rescinded.
The only shots that had been still been authorized under an EUA were kids ages 11 and under. The move could hinder access to shots for healthy kids.
In a statement, Dr. Susan Kressly, president of the American Academy of Pediatrics AAP, called the decision “deeply troubling.”
“As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families. Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing,” Kressly said.
Doctors will still be able to prescribe the vaccines off-label, to people not specified in the FDA approvals. However, that adds yet another barrier to access as many people get their shots at the pharmacy, not prescribed through a doctor.
The approval is expected to go to the Centers for Disease Control and Prevention’s vaccine advisory committee, which will make a recommendation on who should be able to get the shots. In June, Kennedy fired all 17 members of the panel and replaced them with his own picks, including several Covid vaccine skeptics.
The new restrictions — which were expected — are likely to affect what insurers cover for people who don’t qualify for the updated Covid shots.
Prior to this change, the CDC recommended Covid shots for everyone 6 months and older.
A Covid shot can cost up to $140 without insurance, according to the CDC’s vaccine price list.
In his post, Kennedy did not specify which medical conditions put a person at a higher risk of severe illness. However, the CDC website lists dozens of conditions either linked to or suggestive of higher risk, including asthma, cancer, heart conditions, diabetes, disabilities and depression.
In a notable departure, major medical organizations have come out with their own vaccine recommendations in recent weeks. Usually, these groups follow the CDC’s guidance.
Last week, the American College of Obstetricians and Gynecologists issued guidance recommending the Covid vaccine — as well as flu and RSV vaccines — for pregnant women. The American Academy of Pediatrics published its own vaccination schedule earlier this month, which included the Covid vaccine. On Tuesday, the American College of Cardiology endorsed Covid, flu and RSV vaccines for people with heart disease.
Covid cases have been rising in parts of the U.S., particularly in the South and California, driven by a new variant. According to the CDC, emergency room visits and hospitalizations related to Covid have increased slightly in recent weeks, although much lower than this time last year.
