WASHINGTON — The Food and Drug Administration on Wednesday restricted access to COVID-19 vaccines by ending their emergency authorization and refining eligibility standards to exclude most healthy adults and children.
Health and Human Services Secretary Robert F. Kennedy Jr., a skeptic of vaccine safety, said in a statement that new policies were rooted in “science, safety, and common sense.”
Under the new rules, people over age 65 will remain eligible to get vaccines, but younger adults will need to establish they have an underlying condition such as asthma or obesity that puts them at higher risk for the illness.
That potentially eliminates access among broad swaths of the public — in a sharp break from the social pressure, shaming, mandates and firings of adults who refused to be vaccinated in 2021 and 2022.
Booster shots previously were easy to get and dispensed alongside the annual flu shot, which does not require the recipient to have elevated risk.
Kennedy, whose department includes the FDA, announced the news on X.
“I promised 4 things: 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,” Kennedy wrote.
“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for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded.
“FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+),” Kennedy went on.
“These vaccines are available for all patients who choose them after consulting with their doctors. The American people demanded science, safety, and common sense. This framework delivers all three.”
The vaccine-makers clarified the new eligibility standards in their own press statements.
Pfizer said that the FDA authorization it receives requires people “ages 5 through 64 years” to have “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.”
Moderna noted its vaccine is “now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults 65 years of age and older.”
Novavax, a newer option that was not among the first to hit the market, said that “individuals 12 through 64 years” must now ‘have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking).”
More than 73% of Americans got at least one COVID-19 vaccine shot as of late 2021, with the holdouts at the time — who pointed to rare side-effects such as heart conditions or simply said they weren’t interested — invoking the wrath of the Biden administration.
“We’ve been patient, but our patience is wearing thin, and your refusal has cost all of us,” then-President Joe Biden raged at the time as he imposed a vaccine mandate on all federal workers.
The first wave of coronavirus vaccines were developed in 2020 during the final year of President Trump’s first term with billions in federal funding under Operation Warp Speed. They initially were extremely effective at blocking transmission of the virus, though later mutations increasingly eluded the shots, which still reduced symptoms.
The success of vaccine clinical trials, announced mere days after Trump lost reelection to Biden, heralded the beginning of the end of the pandemic that killed more than 1 million Americans and caused massive economic, social and educational upheaval.
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