WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations for the vaccines, in a set of moves that could make the shots more difficult to obtain for children under 5, in particular.
The moves were announced by Robert F. Kennedy Jr., the secretary of health and human services, in a post on the social media site X. He portrayed the actions as fulfilling a campaign promise to reverse Covid-era policies while still allowing people to access vaccines.
“I promised 4 things,” Kennedy wrote. “ 1. to end covid vaccine mandates; 2. to keep vaccines available to people who want them, especially the vulnerable; 3. to demand placebo-controlled trials from companies; 4. to end the emergency.
“In a series of FDA actions today we accomplished all four goals. The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded.”
Covid vaccine authorizations for all three available vaccines, Kennedy said, would now only be for higher risk individuals, including those over sixty-five and those who have risk factors for developing severe Covid. Kennedy said that the Moderna vaccine is approved for those older than six months, the Pfizer/BioNTech vaccine for those older than five years, and the Novavax shot for those older than 12.
Pfizer said in a press release that its shot, targeted against SARS-CoV-2 sublineage LP.8.1 based on FDA advice, would be approved for those over 65 and for those aged 5 to 64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
“These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy wrote. “The American people demanded science, safety, and common sense. This framework delivers all three.”
Pfizer said shipping of its vaccine will begin immediately and that it can provide a robust supply of the shots to pharmacies, hospitals, and clinics across the country.
The move has the effect of limiting the availability of Pfizer’s Covid-19 vaccine for children under age 5. The shot was previously available to children as young as 6 months via the emergency use authorization. That could make it more challenging for healthy children in that age group to receive Covid shots this fall.
The FDA approved Moderna’s vaccine for children as young as 6 months in July, but only for those with an underlying condition. Pfizer’s shot, which was developed in partnership with BioNTech, was seen as the main option for parents wishing to inoculate their young, healthy children against Covid.
It’s unclear how willing doctors might be to offer Moderna’s shot to young children off-label, and whether insurers will continue to pay for the immunizations.
Agency officials, like FDA Commissioner Marty Makary and top vaccine regulator Vinay Prasad, have argued that the risks of Covid vaccines outweigh the benefits for healthy children and note that uptake of the shots, both for children and adults, has been low in recent years. Prasad overruled dozens of career scientists to limit Covid vaccine approvals three times in the past few months, including Moderna’s vaccine.
This is a developing story and will be updated.
