Not unilaterally, vaccine law experts say. Although there are ways the administration can make COVID-19 vaccines harder for Americans to get, there’s a process for taking approved vaccines off the market, and attempts to take vaccines off the market could face legal challenges.
“The Administration is relying on gold standard science and is committed to radical transparency to make decisions that affect all Americans,” White House spokesman Kush Desai told PolitiFact when asked about The Daily Beast’s report that the administration was considering a COVID-19 vaccine ban. “Unless announced by the Administration, however, any discussion about HHS policy should be dismissed as baseless speculation.”
An HHS spokesperson said the agency doesn’t comment on potential policy decisions.
Can HHS remove approved vaccines from the market?
To take an approved vaccine off the market, the U.S. Food and Drug Administration would have to revoke the manufacturers’ license for that vaccine.
The FDA has licensed and approved three COVID-19 vaccines for at least some segments of the population. Those include two mRNA vaccines — one made by Moderna and another made by Pfizer-BioNTech — and Novavax’s protein-based vaccine.
The FDA’s approval of the COVID-19 vaccines — in some cases, during Trump’s current term — could make it more difficult to completely remove them from the market.
The FDA could try to remove a vaccine if the agency had significant safety concerns or “concerns about manufacturing practices,” reported KFF, a nonprofit health policy research, polling and news organization.
For years, Kennedy has said that vaccines are inadequately tested and unsafe.
But federal regulations specify how the FDA would revoke a license, said Dorit Reiss, a vaccine law and policy expert at University of California Law San Francisco.
“You need to meet procedural requirements and show that the removal was not arbitrary and capricious,” Reiss told PolitiFact in November.
It can be done, though: The FDA recently announced it suspended a French drugmaker’s license for a live-attenuated vaccine that protects against chikungunya, a virus spread by mosquitoes.
Kenendy has also already made moves that reduce Americans’ access to the COVID-19 vaccines.
In May, Kennedy announced he’d removed COVID-19 vaccines from the recommended immunization schedule for healthy children and pregnant women — a move that could limit vaccine access by reducing insurance companies’ coverage of the shot. The FDA also announced that vaccine makers seeking approval for future COVID-19 vaccines, or boosters, would need to conduct new randomized clinical trials of healthy populations. Such moves are expected to limit COVID-19 vaccine access.
Steps toward revoking an approved vaccine
Under federal rules, the FDA commissioner — not the HHS secretary — can try to revoke a vaccine license. FDA Commissioner Marty Makary is a pancreatic surgeon and a proponent of the “Make America Healthy Again” movement; he said he has a good relationship with Kennedy.
Makary could seek to revoke a vaccine’s license if, as the law outlines, he found it “fails to conform to the applicable standards” that ensure the product’s “continued safety, purity, and potency” or if he determined “the licensed product is not safe and effective” for its intended uses.
The FDA commissioner typically must notify the vaccine manufacturer of the agency’s plans to revoke the license, provide the agency’s grounds for the revocation and give the manufacturer an opportunity for a hearing. An FDA official known as an administrative adjudicator — an executive branch official — would preside over the hearing, Reiss said.
“It should be a chance to provide safety data and lay out their case,” she said. After the hearing, the FDA would decide whether to revoke the license and the company could then challenge a revocation, Reiss said.
Initiating the procedure to remove an approved vaccine “without new information and sufficient evidence of harms or other concerns” would likely trigger legal challenges, KFF said.
“Most vaccines that were removed from the market were removed voluntarily, so there’s not really a lot of experience,” Reiss said. “Companies do not always sue FDA; it might not be cost-effective to do so. But they can, and I would be surprised if none of them do.”
Wendy Parmet, director of Northeastern University law school’s Center for Health Policy and Law, said that if the vaccine manufacturers contested a license revocation, she expected they would have a strong case, given the reams of vaccine safety data and post-market studies of COVID-19 vaccine use around the world.
But some companies have been unwilling to fight the Trump administration, she said.
“They’ve already lost contracts from mRNA research,” Parmet said, referring to Kennedy’s decision to cut mRNA vaccine development funding. And the companies have broad portfolios with numerous business interests that could be affected by the Trump administration’s policies more widely.
“Are they going to be afraid that they’ll be hit with retaliatory tariffs?” Parmet said. “We’ve seen companies being afraid of asserting their rights because they’re being pressured in other ways.”
If vaccine manufacturers don’t challenge the government, physicians groups or patients groups could file legal challenges, Parmet said.
“I think there’ll be litigation. I would expect a court to try to give temporary relief,” she said. “But we’ve seen the Trump administration have greater success the higher up the judicial ladder we go. So I don’t know what’s going to happen.”
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