The latest COVID vaccines come with new FDA limits

The Food and Drug Administration approved the next round of COVID-19 vaccines Wednesday, but imposed new restrictions on who's eligible to get receive them.

The agency is limiting the updated shots to people who are at risk for serious complications because they are 65 or older or have other health problems. Until now, COVID vaccines had been available to anyone 6 months and older regardless of their health.

The decision is expected to make it harder for many people, such as healthy children and healthy younger adults, to get a shot ahead of the expected winter COVID surge. That's already generating confusion and apprehension that harkens back to the early days of the pandemic, when people often had to frantically search for a shot.

"I'm feeling a little déjà vu," says Clare Hannan, executive director of the Association of Immunization Managers. "There's a lot of anxiety about being able to get the vaccine."

The Centers for Disease Control and Prevention is expected to weigh in soon with influential recommendations on who should get inoculated. But the CDC has already dropped guidelines that call for all healthy children and healthy pregnant women to routinely get vaccinated – a decision many doctors and public health experts say is especially alarming.

Federal health officials say the changes are warranted because most people have so much immunity at this point. They also question the vaccines' safety and effectiveness – doubts dismissed by most public health experts and contradicted by a large body of scientific evidence.

A sweeping change to COVID vaccine regulation

"The American people demanded science, safety, and common sense. This framework delivers all three," Health and Human Services Secretary Robert F. Kennedy Jr. said in a post about the regulatory actions on X.

Kennedy said the FDA has approved Moderna's mRNA vaccine for those ages 6 months and older, the Pfizer-BioNTech mRNA vaccine for those ages 5 and older, and the Novavax vaccine, which uses an older technology, for those ages 12 and older.

"These vaccines are available for all patients who choose them after consulting with their doctors," Kennedy wrote, adding that the emergency use authorizations for the vaccines that made them available quickly during pandemic had been revoked.

"It's a welcome but overdue end to a policy," says David Gortler, a senior research fellow at the Heritage Foundation. "But it is unclear as to why the EUA remained in place at all following full authorization by the FDA and the fact that the COVID emergency officially ended on May 11th 2023 — almost 30 months ago."

Gortler adds, "Although the CDC very recently stopped publishing how many adults and children are still getting the COVID boosters in 2025, at last count it was around 23 million adults and 9.5 million kids, none of whom should be getting any mRNA covid injections."

Access to COVID vaccines could be difficult for many

While many people with concerns about the vaccines welcomed the new restrictions, the limitations could limit access and are being denounced by most public health authorities as unwarranted, unscientific and dangerous.

"I'm worried that this puts the entire American population at risk for severe COVID disease and the complications associated with it," says Dr. Tina Tan of Northwestern University, the president of the Infectious Disease Society of America. "People who are not going to be able to get the vaccine if they want it. And you're going to see an increase in the number of individuals that are hospitalized or that potentially could die."

The moves are the latest in a series of steps Kennedy, a long-time and vocal critic of vaccines, has taken to curtail development and availability of vaccines. He's downplayed the risks of infectious diseases, falsely claimed vaccines are risky, canceled hundreds of millions of dollars of research to develop new mRNA vaccines to protect against future pandemics, replaced a key federal advisory committee with like-minded skeptics, and has threatened to overhaul protections for vaccine makers.

The new restrictions on the updated COVID vaccines, which target the LP.8.1 omicron subvariant, mean insurance may no longer pay for the shots, doctors may balk at stocking and prescribing them, and pharmacists may be unable or unwilling to administer the vaccines.

"The restrictions are not following the science of what these vaccines can and will do," says Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. "This is a disaster waiting to happen."

Risk factors and worries about protection

The announcement comes after the FDA signaled the new approach in the spring. Kennedy soon after announced plans to drop recommendations for vaccinations for children and pregnant women. The moves prompted outrage among public health experts and fear, confusion and anger among people who still want to get vaccinated.

Still, the list of health problems that would make people eligible for the vaccines is very broad. Qualifying risk factors apparently include weak immune systems, asthma, depression, diabetes, high blood pressure and a sedentary lifestyle.

The new vaccine rules come as a consensus was emerging among government and independent scientists that routine vaccination may no longer be necessary for some people, such as healthy younger adults and older children because so many have built up strong immunity.

Nevertheless, the moves prompted major medical groups like the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists and independent expert groups like the Vaccine Integrity Project, to issue their own scientific assessments and guidelines. Those continue to recommend the shots for all pregnant people and all very young children, who are as likely as older adults to get seriously ill from COVID.

"I'm worried," says Dr. Sean O'Leary, a pediatric infectious disease expert at the University of Colorado who chairs the pediatric association's committee on infectious diseases. "It's clear the youngest kids remain at very high risk. So it's very important to keep recommending the vaccine to those kids."

Newborn babies face an especially high risk, O'Leary says, because they have little or no immunity. The best way to protect them is to vaccinate women during their pregnancies so they can pass protective antibodies to their fetuses. Pregnant women are themselves at high risk for serious complications as well.

"It's heartbreaking," says Dr. Lakshmi Panagiotakopoulos, a former CDC vaccine expert. "I honestly believe this will do harm to the American public."

Adding to the confusion is the fact that although the CDC is no longer recommending the vaccines for healthy pregnant women. The agency and the FDA's new framework both still list pregnancy as a risk factor.

Trade groups representing insurance companies have said their members plan to continue paying for the shots even though they're no longer required to in all cases because of the current CDC recommendations. It remains unclear, however, how many individual insurers will still broadly cover the vaccines.

Most people have stopped getting vaccinated and most parents don't inoculate their kids. But many younger, healthy adults still want a shot because they're worried about getting sick, missing work, developing long COVID or spreading the virus to vulnerable family members.

"And my feeling is those healthy young adults should have the freedom to discuss this option, to consider it with their health care providers, and even if they don't have health conditions should have the freedom to get vaccinated," says Dr. Jesse Goodman, a former FDA vaccine regulator now at Georgetown University.

Many parents also want the choice to vaccinate their otherwise healthy children for the same reasons.

People who are not officially eligible for the vaccines may still be able to get the shots for themselves or their children by getting a doctor's prescription and paying out of pocket. But that may create insurmountable barriers for many people. The COVID shots can cost $200 or more without insurance, getting a doctor's appointment can be difficult for vaccination can be difficult..

In addition, many doctors may be hesitant to prescribe the shots beyond the FDA approval, also known as off-label use, and many pharmacists may be unable or uneasy about administering the vaccines because of state restrictions and liability concerns. Nineteen states require pharmacists to follow the CDC's guidelines, according to the American Pharmacists Association. The rules vary in the remaining states.

Even if pregnant women and others can get vaccinated, many public health experts worry the conflicting recommendations and messages could dissuade many people from trying, exacerbating the already low rates of vaccination.

"We know that when people are confused they don't act and my concern is that a lot of people who would benefit from COVID vaccination are not going to get it because they are just not sure what they should be doing," says Dr. Kelly Moore, who heads Immunize.org, an advocacy group.

The changes come as the U.S. is in the midst of yet another summer COVID wave, which has caused a surge of children requiring emergency care at hospitals and is claiming more than 100 lives weekly.
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