The CDC on Monday accepted controversial new guidelines for the updated COVID-19 vaccines that could make it harder for many people to protect themselves this winter compared with previous years.
Acting CDC Director Jim O'Neill agreed to the recommendations for the COVID shots from Health Secretary Robert F. Kennedy Jr.'s handpicked Advisory Committee on Immunization Practices, which met in September.
Unlike in earlier years, the new guidelines call for people to talk to a doctor, pharmacist or some other health care provider about the risks and benefits of getting vaccinated before they get a shot. This extra step is called "shared decision-making,"or "individual-based decision-making," according to the language in the news release.
The move is the final action necessary for implementing the new guidelines, which affect who can get and give the COVID shot, and whether vaccination will be covered by private and government insurance without copayments.
Final recommendations were delayed
The step came after an unusual, unexplained two-week lag between when CDC advisers issued the recommendations and the agency accepted them. The official decision allows the CDC to finally start shipping vaccines to doctors, clinics and other providers through the Vaccines for Children Program, which provides vaccines free to about 40% of all U.S. children.
"Informed consent is back," O'Neill said in a statement announcing the step. "CDC's 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today."
Independent vaccine experts challenged that claim.
"There is no basis to claim that routine recommendations prevent doctors from discussing risks and benefits with patients," said Dorit Reiss, who studies vaccine policies at the University of California, San Francisco. "Doctors [have always been] required to get informed consent. Shared clinical decision-making simply signals the vaccine is not routinely recommended and decreases uptake."
Others agree O'Neill's claim is false and could undermine public confidence in the vaccines.
"The claim that the past recommendations deterred health care professionals from talking to patients about risks is completely untrue and is another example of the misinformation and made up information that this administration continues to release to the public and further creates confusion and distrust in healthcare providers and vaccines," wrote Dr. Tina Tan, the president of the Infectious Diseases Society of America, in an email. "This is extremely unfortunate and critically increases the American public's risk for serious vaccine preventable diseases."
The CDC also formalized a recommendation that makes it more complicated for some parents to get their babies vaccinated against measles, mumps, rubella and chickenpox.
"If that's his approach, I am concerned about [additional] childhood vaccines recommended for routine use," Reiss added in an email. "If he thinks a routine recommendation undermines informed consent — which it doesn't — that could further reduce uptake and may make the Trump-Kennedy outbreaks of measles and pertussis we are seeing even larger."
The moves guarantee continued insurance coverage for the COVID shots and allows pharmacists nationwide to keep administering the vaccines. But the changes withdraw some government coverage for the combination shot that protects against measles, mumps, rubella and chickenpox and that some parents prefer.
In previous years, the COVID-19 vaccines have been easily available for free to anyone 6 months and older by simply walking into a pharmacy, doctor's office or clinic and asking for a shot.
Barriers to vaccination
But the vaccines became harder to get in August, when the Food and Drug Administration approved updated versions of the Moderna, Pfizer/BioNTech and Novavax vaccines only for people at increased risk for serious disease because they are age 65 or older or had some other health issue.
The change occurred because top Trump administration health officials say they have concerns about the safety and effectiveness of the vaccines, even though there is overwhelming evidence the vaccines are very safe and highly effective. Federal health officials also argue that most people have so much immunity now that they don't necessarily need annual boosters anymore.
Many public health experts agree that COVID no longer poses the serious risk it once did to many people, especially those who are younger and otherwise healthy. Other countries have also shifted to a more "risk-based" COVID vaccination strategy.
But some healthy people still want to get vaccinated to reduce their risk of getting sick at all, missing work or school, developing long COVID or spreading the virus to vulnerable people, such as older family members and friends with other health issues.
Over the past month, the change caused anger, frustration and confusion. In states like Georgia and Utah, people had to get a prescription to get a shot and some couldn't get vaccinated at all.
The situation was further complicated because Kennedy, who has a long history of criticizing vaccines, said the government was no longer recommending the vaccines for pregnant women and healthy children, even though pregnancy is listed as a risk factor by the CDC and FDA, and COVID can still make some kids very sick.
Earlier this month, the vaccine panel, which gives influential advice to the CDC, voted to recommend the shots for anyone 6 months and older, provided they consult with a health care provider about the risks and benefits.
Confusion still reigns
The requirement for shared clinical decision-making creates a new hurdle to getting vaccinated compared with previous years, by explicitly requiring a conversation with a provider on an individual's risks and benefits before they get one.
The new guidelines continue to ensure coverage by private and public insurers, including Medicaid, Medicare, the Vaccines for Children Program and the Children's Health Insurance Program.
The recommendation should also clarify that anyone age 6 months and older is eligible for the COVID vaccine, including healthy children, pregnant women and younger adults. (The only way to protect younger babies, who are among those who face the greatest risk from COVID, is by immunizing their mothers during pregnancy.)
But some providers may remain confused or hesitant to administer the shots because of lingering uncertainty and mixed messages, for instance, speculative safety risks presented during the CDC's advisory committee meeting that are not backed by solid evidence.
Some states and major medical groups like the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Infectious Diseases Society of America have issued separate guidelines recommending the shots to most everyone ages 6 months and up, to protect themselves and their communities this upcoming respiratory virus season.
In addition, more doctor's offices may opt against stocking the new vaccines because of concerns the debate may further dampen demand, requiring people to go elsewhere, such as a pharmacy.
Some pharmacies may require patients to read and fill out a form that discusses the potential risks and benefits of the vaccines. But CVS, the nation's largest pharmacy chain, says people will be able to get a COVID vaccines simply by asking for one. Pharmacists won't have to require anything, including even a conversation, unless patients have questions, CVS says.
A separate shot for chickenpox is now recommended
O'Neill also accepted the panel's vote to ban the MMRV combination shot, which protects against measles, mumps, rubella and varicella, or chickenpox, for children under 4.
Young children can gain the same protection by getting separate shots for MMR and varicella, and most of them – some 85% – already do, according to CDC data shared and discussed at the advisory committee's September meeting.
That's because the combination shot is associated with a slightly higher risk of fevers that can lead to seizures in kids under 4. Because of the risk the CDC has, for more than 15 years, preferred that children under 4 receive the shots separately. Still, some parents were choosing to get the combo shot, because it was easier or more available, and the risk associated with the potentially frightening but temporary side effect is low.
Because of the recommendation, the MMRV vaccine will no longer be covered by federal programs that offer subsidized vaccines. "This panel has made a recommendation for a practice that's essentially in place anyway, but removed the option of having those vaccines financed for those who may think this is a better option," says Dr. Katrina Kretsinger, a medical epidemiologist who worked on vaccine policy for more than a decade at CDC, before retiring from the agency in 2023, "This is effectively removing a choice from parents."
Making different policies from the same safety information that was thoroughly examined years ago will also raise mistrust among parents, Kretsinger says. "There is confusion about how to proceed, and also doubts raised by the fact that this is being re-examined," she says, "It furthers the chilling effect on vaccine uptake."
The change may also cause shortages of the separate vaccines, at least initially, until manufacturers can adjust their production to meet the new demand.
A fresh call to break up the MMR vaccine
A few hours after issuing the new vaccine guidelines, Acting CDC Director O'Neill also called on makers of the combined MMR vaccine to break it up into three separate shots for measles, mumps and rubella in a post on X.com. The post praised President Trump for his leadership and reposted his call in September that the MMR vaccine be administered as "THREE TOTALLY SEPARATE SHOTS."
The combination shot for measles, mumps and rubella has been used in the U.S. for decades.
"This really is absolutely completely ridiculous and really sets us back over 50 years in time given that the MMR vaccine was licensed here in the US in 1971," said Tan, president of the Infectious Diseases Society of America, in an email. "It was made as a combination vaccine to ensure that persons would receive all the vaccines that they would need as a single shot as opposed to 3 separate injections. This is crazy and continues to erode the public health system and the public trust in vaccines."
"There is no published scientific evidence that shows any benefit in separating the combination MMR vaccine into three individual shots," said a statement from Merck, which makes an MMR vaccine. "Use of the individual components of combination vaccines increases the number of injections for the individual and may result in delayed or missed immunizations."
The statement also said that evidence suggests combination vaccines improve outcomes for kids by increasing completion of recommended vaccines and getting them at the right ages. Merck also said there are no single-shot vaccines approved for use in the U.S. for measles, mumps or rubella.
"Combination vaccines play a crucial role in improving vaccination coverage rates; their safety and efficacy have been demonstrated by decades of research," said a statement from GSK, maker of the other MMR vaccine available in the U.S. "By reducing the number of separate injections required, combination vaccines allow for a simpler and more efficient immunization process, which is essential for timely protection against disease."
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