The FDA and CDC will no longer recommend annual COVID vaccinations for healthy people younger than age 65, overturning past official U.S. health policy.
"I couldn't be more pleased to announce that as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," said Health Secretary Robert F. Kennedy, Jr., in a video statement released via X on May 27.
The FDA announced in May that adults over age 65 and anyone over 6 months with one or more chronic or underlying health conditions, such as asthma, cancer, diabetes or pregnancy, were still recommended to get an updated shot. The CDC later clarified separately that children and pregnant people may still choose to get COVID shots, even though the U.S. health agencies no longer explicitly say they should.
The shift was a marked departure from previous guidance, which recommended an annual COVID vaccine for everyone 6 months and older. The FDA's new blueprint estimated 100 to 200 million people would be eligible under the new guidelines.
WATCH: FDA commissioner defends changes to COVID vaccine recommendations
To gain approval for COVID vaccines for other groups in the future, pharmaceutical companies would need to conduct new randomized clinical trials for younger healthy populations, according to Makary and Dr. Vinayak Prasad, who directs the FDA's Center for Biologics Evaluation and Research.
"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk," Makary and Prasad wrote May 20 in the New England Journal of Medicine.
Requiring trials "will provide information that is desperately craved by health care providers and the American people," Makary and Prasad wrote.
But other experts are worried about hindering the nation's ability to develop timely vaccines against future pathogens while withholding vaccine doses from healthy people who want further protection now.
The new guidance from both the FDA and CDC preempts a scheduled meeting of a CDC advisory panel in June, where experts would typically meet to discuss the vaccine recommendations.
Here's what the recent changes could mean for you.
Under the new recommendations, who should get a COVID vaccine?
Healthy adults under the age of 65 and children aged 6 months or older are not recommended to receive the updated COVID vaccines going forward, according to the FDA.
FDA officials under the current Trump administration said Tuesday the virus has infected many Americans "multiple times" and claimed that there has been "a reduction in the evidence standard for dose after dose," Prasad said.
There are some exceptions for people with underlying conditions, including:
- Asthma
- Cancer
- Diabetes
- Pregnancy
- Depression
- Chronic lung diseases
- HIV
In his announcement, Kennedy said future COVID vaccines would not be recommended for "healthy, pregnant women."
What did the CDC say about vaccines for kids and pregnant people?
The CDC now recommends that parents ask their pediatrician if the COVID vaccine is appropriate for their individual children. This would apply to children who are ages 6 months to 17 years old and who do not have known health complications.
"Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian," according to the CDC's website.
After conflicting messages from the FDA and the Department of Health and Human Services, Dr. Susan Kressley, president of the American Academy of Pediatrics, said in a written statement that she was "relieved" with the CDC's updated recommendation.
"American families deserve better. They deserve clear messages from all involved in their health, that are based on facts so they can continue to benefit from the success story of vaccines," Kressley said in the statement.
The American College of Obstetricians and Gynecologists said in a statement that it was "concerned" and "extremely disappointed" by the Trump administration's exclusion of pregnant people from receiving updated COVID vaccines. Pregnancy has been shown to raise the risks of developing severe COVID.
"Following this announcement, we are worried about our patients in the future, who may be less likely to choose vaccination during pregnancy despite the clear and definitive evidence demonstrating its benefit," ACOG President Dr. Steven J. Fleischman said in a written statement. "We are concerned about access implications, and what this recommendation will mean for insurance coverage of the COVID vaccine for those who do choose to get vaccinated during pregnancy. And as ob-gyns, we are very concerned about the potential deterioration of vaccine confidence in the future."
What do these COVID shot changes mean for families and care workers?
While vaccine coverage would remain the same for people over age 65 or anyone six months or older with underlying risk factors, the people who share their lives or close quarters may not get the same protection. Healthy people who live in the same household or health care and child care providers who have no chronic conditions would not qualify to receive updated doses under these recommendations.
These restrictions may result in continued declines in COVID vaccine uptake.
Historically, the U.S. has "not been great at a targeted and tailored approach" to vaccine access, said Abram Wagner, an assistant professor of epidemiology and global public health at the University of Michigan. "The more you put restrictions into place, it just filters down that it's more and more difficult to get the vaccine."
Why did the FDA say COVID vaccine changes were necessary?
FDA officials pointed to similar recommendations in other nations, including Canada, Denmark and Australia, as validation for this policy change.
"It would almost seem as if the current U.S. strategy, which is urging every single baby and teenager and child and healthy American and high-risk American, encouraging every single one to get a booster every year, that is the outlier, contrary approach," said Makary during a livestreamed question-and-answer session. Prasad agreed, adding, "Now, we are back in line with the rest of the world."
Overall, Bill Hanage, professor of epidemiology at T.H. Chan School of Public Health at Harvard University, said it is "quite reasonable" to say that not everyone will benefit equally from receiving the COVID vaccine. However, he said the countries FDA officials pointed to "typically have health systems that in this country would be considered socialized."
Where does the Trump administration stand on vaccines?
Kennedy was the founder and chairman of an anti-vaccine advocacy organization for years. Though Kennedy affirmed support for the measles-mumps-rubella vaccine in a Senate hearing on Tuesday, when asked last week whether he supported vaccinating his own child, Kennedy said he does not think people should take medical advice from him. At his confirmation hearings, senators on both sides of the aisle expressed concern about Kennedy's stance and the importance of live-saving vaccines.
Public trust in vaccines and vaccination uptake have declined in the U.S. in recent years. Prasad called this trend in attitudes "a backlash" that has led to "reduced rates of important, vital vaccine programs." That includes the MMR vaccine, "which has been clearly established as safe and highly effective," Makary and Prasad wrote in NEJM.
Days before the FDA's COVID recommendations were released, Makary announced he was planning to "unleash a massive framework" on the FDA's expectations for vaccine makers.
The new change to COVID vaccine recommendations was unexpected in part because the Centers for Disease Control and Prevention usually offers the public guidelines for who should get what and when. The FDA regulates the use of vaccines, medicines and medical devices based on whether they are safe and effective. The CDC's Advisory Committee on Immunization Practices is scheduled to meet in late June and is expected to discuss who should receive COVID vaccines then.
Will insurance cover updated vaccines? Will people who want a shot be able to get it?
On May 20, Makary said the FDA would stick to its "general promise that we are not going to be removing vaccines from the market that are already approved."
That's where the CDC appears to have come in. That agency can add a provision that allows healthy people under age 65 to get vaccinated against COVID if that is their choice, said Dr. William Schaffner, professor of infectious disease at Vanderbilt University.
Because the CDC's latest changes kept the COVID vaccine in the childhood immunization schedule, Kressley said that "means that the vaccines would be covered by insurance."
However, people may have to pay for those doses out of pocket as insurance companies are unlikely to cover COVID vaccines for healthy populations unless they are "standardized on the vaccine schedule," Poland said. "Given the current politics, I don't see CDC endorsing something counter to what DHHS and FDA are doing."
How will these changes affect the next COVID booster?
The changes announced by the FDA could cause major delays when a more nimble response to fast-moving viruses like SARS-COV-2 is needed. Requiring clinical trials of vaccines targeting pathogens that change rapidly "is just not feasible," Wagner said.
"This is really shackling the development and utilization of vaccines," Poland said.
It is also unclear how these changes will result in getting more people vaccinated, Hanage said.
What it is likely to do is "to make it more difficult for people who would like to get a vaccine to get one," he said. "This is effectively a no-vaccine mandate for a large number of Americans."