Major changes are coming for those who want the new COVID-19 shot this fall. Up until now, anyone 6 months and older who wanted the new COVID shot, which is updated each fall to better match the circulating COVID variants, was eligible to get it.
Now, it’s been announced that the U.S. Food and Drug Administration is changing the recommendations for the fall COVID-19 shot. Those now eligible for the shot include people over the age of 65 and people 6 months and up who have underlying medical conditions — but younger, healthy people won’t be eligible for the jab.
“I’m concerned about this new decision by the FDA to limit the COVID-19 vaccine to people 65 and older and people over 6 months with at least one known underlying medical condition. It’s a dramatic shift from the current CDC guidance, which recommends the vaccine for anyone 6 months and older,” Dr. Oni Blackstock, a primary care and HIV physician who is the founder and executive director of Health Justice, a racial and health equity consulting company, told HuffPost.
“I think [the new COVID shot guidelines] lack an evidence base and a clear rationale for changing them,” Tara Smith, a professor of epidemiology, told HuffPost.
Smith added that these changes don’t seem to be based on any new data from Dr. Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, or Dr. Marty Makary, the commissioner of the FDA. “It seems to be based more on ‘vibes’ and a low uptake of updated COVID vaccines overall, but that is not a scientific reason to change vaccine eligibility,” Smith said.
The U.S. Department of Health and Human Services (HHS) didn’t respond to experts’ specific criticisms when HuffPost asked for comment, instead responding with a lengthy statement that said the COVID-19 public health emergency is over. The statement continued that the U.S. is in a new virus-response phase in which “a rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden Administration is now over.”
HHS’s response also referenced the FDA’s new recommendation framework published in the New England Journal of Medicine, saying it “provides forward-looking guidance for a risk stratified approach, rooted in the best available science, to inform future vaccine policy.”
Doctors and scientists have concerns about multiple aspects of these eligibility changes, along with the data being used to move these changes forward. Here’s what they’re worried about:
Some experts say the FDA is intentionally misconstruing international COVID vaccination guidelines to align with its new recommendations.
“In their policy paper in [the New England Journal of Medicine], the FDA authors justified implementing vaccine restrictions in the U.S. by claiming that other countries such Australia and Canada have already limited the COVID vaccines to older and higher risk people. But this is false,” Lucky Tran, a scientist and public health communicator, told HuffPost.
“While countries like Australia and Canada make strong recommendations for older people and higher risk groups, COVID vaccines continue to be available to everyone. The FDA authors are deliberately misrepresenting international policies to further their political goals,” Tran added.
For example, Canada’s official COVID immunization guidelines list out that the vaccine is recommended for people at high risk, including people over 65, health care workers, pregnant people and more. Then, the guidelines go on to say, “all individuals (previously vaccinated and unvaccinated) 6 months of age and over not in the preceding list may receive the COVID-19 vaccine.”
Under the Trump administration in the U.S., clinical trials would be required for the vaccines to be approved for use in low-risk people. “The suggestion that we need new placebo-controlled trials for updated vaccines is particularly concerning. On its surface, it may sound reasonable, but ethically, it’s dangerous to withhold a vaccine that is known to offer protection just to create a placebo-controlled new trial. And practically, it may be impossible to carry out,” Dr. David Higgins, a pediatrician and preventive medicine specialist at the University of Colorado Anschutz Medical Campus, told HuffPost via email.
Moreover, it’s unfair to use countries like Australia and Canada (and Sweden and Germany and the other countries listed in the FDA’s policy paper) as a comparison. “I believe all of the countries that were used for comparison also have universal health care of some type or another,” Smith said.
“The FDA authors are deliberately misrepresenting international policies to further their political goals.”
– Lucky Tran, scientist and public health communicator
“In the U.S., a serious COVID infection that requires hospitalization could have dire financial consequences beyond the health aspects of infection,” Smith explained.
A Gallup health care survey from earlier this year found that 12% of Americans had to borrow money to pay for medical costs within the past year. And, according to the American Hospital Association, 6% of Americans owe more than $1,000 in medical debt, while 1% owe more than $10,000.
Plus, Republicans are actively trying to take away health care from 8 million Americans through cuts to Medicaid and Medicare via the One Big Beautiful Bill Act. Without health care coverage, even more people could have to consider taking on debt for medical bills. This isn’t the case in the countries referenced with universal health care.
“Given that the U.S. does not [have] universal health care and that people in the U.S. already tend to live shorter, sicker lives compared to those in countries with universal healthcare, limiting access to preventive measures like vaccines could worsen these already existing inequities,” Blackstock said.
Luis Alvarez via Getty Images
Research shows that everyone benefits from the COVID vaccine — not just those at high risk. Taking away vaccine access is dangerous, experts say.
“The data tells us that everyone can benefit from getting updated COVID vaccines,” Tran said.
“COVID vaccines reduce the risk of becoming sick, developing long COVID and becoming hospitalized, for everyone,” Tran added. “COVID continues to spread and cause harm. Limiting access to COVID vaccines is an anti-science move that will kill more Americans.”
This change could mean that younger or otherwise healthy people who want a COVID vaccine may not have access, noted Blackstock.
“Without FDA approval for these groups, insurance companies might not cover the cost, potentially leaving people to pay out of pocket or unable to get vaccinated at all,” Blackstock said.
“Another important point is that vaccines reduce COVID transmission,” Tran said. This is important for everyone, but especially those who are caretakers of people at higher risk of getting COVID.
“For instance, for years my siblings and I took care of our mother until she passed in March. Most of us do not have any eligible conditions to receive the vaccines, so that would have left her less protected from COVID as we would no longer be able to receive updated vaccines,” Smith said.
“I think it is a mistake to rescind access to these vaccines, particularly after RFK Jr. had promised in his hearings that he would not take away our vaccines,” Smith said.
Experts say this entire guideline change process is unusual.
Blackstock is concerned about these vaccine guideline changes and noted that it’s “also unusual for the FDA to provide this level of guidance on a vaccine. It’s usually the CDC that makes specific recommendations on who/which groups should receive a vaccine.”
Higgins agreed — “reevaluating who benefits most from COVID-19 vaccination is an important policy decision. But what’s troubling about these changes is the process. These recommendations were released without pre-decision transparency, without public input and before the advisory committees tasked with reviewing this evidence had a chance to weigh in.”
“We have systems in place to guide these complex decisions transparently and publicly, while representing a variety of perspectives. Bypassing these systems undermines public trust,” Higgins said.
Tran underscored this point. “It’s important to point out that the FDA announced this policy without consulting its own vaccine advisory committee, which is a significant break from standard procedure.”
“It’s also a significant overreach by FDA leaders because recommendations for who should have access to vaccines is ultimately the purview of the CDC and its Advisory Committee on Immunization Practices (ACIP),” Tran noted.
“The FDA is responsible for reviewing clinical trials, and assessing whether a vaccine is safe and effective, not who has access to it,” Tran said.
“The ACIP is expected to vote in June on its own recommendations. Vaccine access is uncertain until we hear from the ACIP and CDC,” Tran said. “However, given the current political landscape at federal agencies, there’s a significant chance they will prioritize politics over public health, and millions of Americans who are under 65 and don’t have a specific medical condition will lose access to COVID vaccines this fall.”
“COVID-19 still poses real risks, even to healthy people, including the potential for long COVID. Everyone deserves the ability to make informed choices about their health and the freedom to choose effective tools for prevention,” Higgins added.