In January the U.S. Department of Health and Human Services (HSS), under the leadership of Secretary Robert F. Kennedy Jr., made significant changes to the nation’s childhood vaccination schedule. For the first time, HHS reduced the number of vaccines recommended for children and young adults, from 17 to 11, putting the agency at odds with the broader medical community.
Vaccines for hepatitis A, hepatitis B, meningitis, rotavirus, influenza, and COVID-19 were switched from the category of “Routine (recommended)” to “Shared clinical decision-making” — when a doctor and a patient or parent discuss the risks and benefits of vaccination. At the same time, the number of doses of the human papillomavirus (HPV) vaccine was cut from two or three (depending on the patient’s age) to one.
Fifteen states have sued HSS over the administration’s changes to the federal vaccine recommendations, but they are in effect for now.
What do the shifts mean for pediatricians and parents? Leading academic medicine experts explain the changes and the possible consequences.
What’s different about the way vaccine-schedule changes were made this time, compared with in the past?
Usually changes to the federal recommendations come after careful deliberation within the Centers for Disease Control and Prevention (CDC) and other government agencies, and meetings of the Advisory Committee on Immunization Practices (ACIP), an external panel of experts. No such review process was undertaken prior to HHS’s recent action, says Yvonne Maldonado, MD, a professor of pediatrics (with a focus on infectious diseases) and of epidemiology and population health at the Stanford University School of Medicine.
“This breaks with established protocols for assessing vaccine benefits and risks,” she says.
“There seems to be little scientific basis for altering the recommendations that have gone through,” adds William Schaffner, MD, a professor of medicine in the Division of Infectious Diseases and of preventive medicine at the Vanderbilt University School of Medicine in Nashville, Tennessee. A former ACIP member, he was also the National Foundation for Infectious Diseases liaison to ACIP for numerous years before ACIP was disbanded and reconstituted by Secretary Kennedy.
What are the potential consequences of relaxing vaccine recommendations?
The altered childhood vaccination schedule will likely reduce their use, potentially leading to a greater burden of disease, experts say.
“If we do not progressively vaccinate children from certain diseases, sooner or later we will see the resurgence of these diseases, just as we are seeing with recent outbreaks of measles [where vaccination rates have declined],” Schaffner says. “The consequences of that will be more sick children, more visits to the doctor, and more hospitalizations.”
| Vaccine | Previous Recommendation | Current HHS Recommendation |
|---|---|---|
| Hepatitis B | First dose at birth; subsequent doses at 1-2 months old and at 6 months | Newborn vaccination for high-risk groups; shared clinical decision-making (SCDM) for others |
| Hepatitis A | Recommended | SCDM |
| Rotavirus | Recommended | SCDM |
| Meningococcal ACWY (types) | Recommended | SCDM |
| Meningococcal B | SCDM | SCDM |
| Influenza | Recommended | SCDM |
| COVID-19 | Recommended | SCDM |
| Human papillomavirus (HPV) | Recommended (2 or 3 doses) | Recommended (1 dose) |
| Diphtheria, tetanus, pertussis (DTaP; Tdap) | Recommended | Recommended |
| Haemophilus influenzae type B (Hib) | Recommended | Recommended |
| Pneumococcal conjugate (PCV) | Recommended | Recommended |
| Inactivated polio | Recommended | Recommended |
| Measles, mumps, rubella (MMR) | Recommended | Recommended |
| Varicella (VAR) | Recommended | Recommended |
| Respiratory syncytial virus (RSV) | Certain high-risk groups | Certain high-risk groups |
| Dengue | Certain high-risk groups | Certain high-risk groups |
Here are the possible implications of reduced uptake of individual vaccines.
Hepatitis B vaccine
Previously administered to newborns, then when an infant is 1 to 2 months old, then at 6 months old or later, the hepatitis B vaccine will no longer be given universally at birth. Delaying the first dose could put many children at risk for the disease and its complications, including cirrhosis and liver cancer.
“The virus is highly infectious and can be transmitted from an infected mother to her child during labor and delivery,” says Maldonado.
Under the new guidelines, the shot can be administered to babies whose mothers test positive for hepatitis B. However, “there’s a relatively high number of mothers in our health care system who either don’t get tested or whose test is done at the time of delivery, or who may have a negative test but who are incubating the virus and may actually be infected,” Maldonado adds.
Before the vaccine became available some 30 years ago, between 200,000 and 300,000 people were infected with hepatitis B each year, data show.
“Pre universal vaccination, there were roughly 15,000 pediatric cases of hepatitis B every year,” says Sean T. O’Leary, MD, MPH, a professor of pediatrics and a pediatric infectious diseases specialist at the University of Colorado Denver Anschutz Medical Campus and Children’s Hospital Colorado. He is also the chair of the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP).
“Roughly 90% of those went on to develop chronic hepatitis, and of those, about a quarter ended up dying from the disease. With universal vaccination, perinatal and pediatric cases of hepatitis B have been extraordinarily rare.”
Already, uptake of the hepatitis B vaccine has been declining. Vaccination rates among U.S. newborns have fallen by more than 10 percentage points over the past two years, a new JAMA study found. The new recommendations could decrease this even further.
- Previous guidelines: Recommended first dose at birth, followed by doses at 1 to 2 months old and at 6 months
- Current guidelines: Recommended only for high-risk individuals (mother tests positive for hepatitis B); for other children, shared clinical decision-making
Hepatitis A vaccine
Hepatitis A, which can be spread from close contact with an infected person, hasn’t been a huge cause of hospitalizations or deaths, especially in children, Maldonado says. But it can cause outbreaks, particularly in areas where children congregate, such as day care centers. Plus, children can bring it home and infect family members, who then have more severe complications, such as liver failure.
“The consequences are not insignificant — and they’re something we can actually do something about,” Maldonado notes.
Routine hepatitis A vaccination of all children ages 12 to 23 months has been in place since 2006, resulting in a 95% decrease in reported cases by 2011, research shows.
- Previous guidelines: Recommended
- Current guidelines: Shared clinical decision-making
Rotavirus vaccine
Rotavirus is a cause of serious diarrheal disease, which can lead to severe dehydration.
“People tend to think that diarrheal disease isn’t a big deal,” says Maldonado. “People can just power through it. And that may be generally true for most adults or older children, but rotavirus can actually be very severe in infants and young children. Over my career, I’ve seen cases of rotavirus disease where children had to be hospitalized because they were so dehydrated.”
Worldwide, rotavirus is a leading cause of diarrheal death, estimated to cause, in 2024, approximately 527,000 deaths, mostly in developing countries, according to the World Health Organization.
Before rotavirus vaccines came to the market in 2006 and 2008, around 55,000 to 70,000 children born in the United States were hospitalized with rotavirus each year, according to the Children’s Hospital of Philadelphia. With the advent of the vaccine, the number has decreased by about 80%, to some 11,000 to 14,000 hospitalizations per year.
- Previous guidelines: Recommended
- Current guidelines: Shared clinical decision-making
Meningococcal ACWY (types) vaccine
Meningitis, which can lead to a potentially fatal bloodstream infection, is not particularly prevalent, Maldonado says. “The concern is that when it happens, there can be explosive outbreaks, where people can die within 24 hours. And you don’t know who’s going to be at risk for developing severe disease.”
That’s why the vaccine has been targeted at adolescents and young adults at times in their lives when they might be congregating — say, in dormitories at college or on military bases.
The prevalence has dropped significantly since vaccines were introduced in 2005, Maldonado says. “There were as many as 3,500 cases of meningitis a year in the U.S. In the vaccine era, there are less than 500 cases a year, and the vast majority of them are in people over 60.”
- Previous guidelines: Recommended
- Current guidelines: Shared clinical decision-making
Influenza vaccine
Flu is a serious cause of seasonal respiratory illness and can sometimes be deadly. In the 2024-25 influenza season, 289 children died from flu. So far in the 2025-26 season there have been 79 pediatric flu deaths. Approximately 90% of the children who died were not vaccinated against influenza, according to CDC data.
A recent modeling study showed that increasing vaccination rates in school-age children by 5% to 15% decreased their symptomatic flu cases by 3% to 10%, which corresponds to an estimated annual reduction in cases of 522,867 to 1,810,170 among school-age children.
- Previous guidelines: Recommended
- Current guidelines: Shared clinical decision-making
COVID-19 vaccine
Removing the “Recommended” status of COVID vaccines, which were rolled out for pediatric populations in 2021 and 2022, is likely to increase serious illness, experts say.
For example, the latest CDC analysis found that kids ages 9 months old to 4 years who received an updated COVID vaccine for the 2024-25 respiratory-virus season were 76% less likely to have to go to the emergency department or urgent care due to the virus, and children ages 5 to 17 who were vaccinated were 56% less likely to need these services.
Generally, children have been less likely to experience severe illness, hospitalization, and death due to COVID-19 compared with adults. But by 2023, the last year for which data are available, the disease killed more than 1,800 children, notes the CDC.
- Previous guidelines: Recommended
- Current guidelines: Shared clinical decision-making
Human papillomavirus vaccine (HPV)
Since vaccines for HPV, a leading cause of cervical cancers, were introduced in 2005, the number of cases has declined by 90%, on average, research shows. According to CDC research, between 2008 and 2022, cervical precancers decreased by 80% among women ages 20 to 24, the age group most likely to be vaccinated for HPV. The vaccine also helps to prevent five other cancers in men and women: vaginal, vulval, anal, penile, and throat (oropharynx).
The recent ESCUDDO trial, involving 20,000 participants, showed that just one dose was 97% effective against the primary cancer-causing HPV types 16 and 18, and performed as well as two doses in preventing infection. And 2024 data involving nearly 448,000 Scottish women found no cases of cervical cancer among those receiving the HPV vaccine at ages 12 or 13, regardless of the number of doses.
“ACIP and AAP, for that matter, had been considering moving to a single dose based on emerging evidence,” says O’Leary.
- Previous guidelines: Recommended in two or three doses (two if the child’s first dose is before age 15; three if the first dose is at 15 or older)
- Current guidelines: Recommended in one dose
How are professional medical groups responding to the vaccine overhaul?
Most physician and infectious disease organizations have reacted to the new vaccination guidelines with concern.
“The professional medical societies are trying to come up with ways to support data-driven analysis and vaccine recommendations,” says Maldonado.
The AAP, in particular, has taken the lead in disseminating vaccine recommendations, which largely restore HHS’s previous recommendations, O’Leary says. To date, 12 other national societies, including the American College of Obstetricians and Gynecologists and the American Medical Association, have endorsed the AAP’s recommendations, he adds. Another 230 organizations, including the AAMC, have formally voiced support for the AAP guidelines.
“The AAP continues to represent the best science that we have,” Maldonado says. “Their recommendations are transparent and were devised by experts in the fields of pediatrics, vaccinology, immunology, epidemiology, and public health.”
How are the new changes affecting pediatric practices and parents with children at vaccine-eligible ages?
Experts say the new guidance is fueling confusion and skepticism.
“As a result, there’s much work that is going on in doctors’ offices,” says Schaffner. “It’s not just one or two parents during the day who are asking questions. Even parents who are generally accepting of vaccines want to talk about [whether their children should have them] and have [this] explained to them from someone they trust.”
While physicians recognize the importance of answering parents’ questions, having to spend time discussing issues that are based on inaccurate information is increasing the burden on doctors, he adds.
Schaffner fears that more parents will withhold vaccines completely, or stretch out the timing, because of the vaccine changes.
“That just gives more opportunities for illness to occur and for outbreaks to flourish,” he says.
How does shifting to shared clinical decision-making affect the uptake of vaccines?
Historically, ACIP applied this concept to cases in which there wasn’t a clear population-level benefit to recommending a vaccine, but the committee wanted to have the vaccine available for people who wanted it, O’Leary says.
“There have been a handful of cases where they used shared clinical decision-making, and when they did, clinicians didn’t like it. What I would hear from clinicians was, ‘You guys are the experts. We want to know whether we should recommend a vaccine or not. If you can’t tell us if we should recommend a vaccine, how are we supposed to figure that out in a 10- or 15-minute office visit with a family?’”
For example, the meningococcal B vaccine, which is currently on the vaccine schedule, was offered on the basis of shared clinical decision-making. O’Leary says that use of the vaccine has been low. Only about a third of age-eligible adolescents have received the vaccine, research shows.
“What clinicians have tended to do is either not even stock the vaccine and not bring it up, or stock it and routinely recommend it,” he says.
The new vaccine schedule is said to be modeled after vaccine recommendations from other Western countries, particularly Denmark. How similar is the U.S. schedule to that of other countries?
O’Leary believes the rationale around comparing the U.S. to “peer” nations is questionable.
“It suggests that we were somehow out of line, and that’s simply false,” he says. “Our immunization schedule is not an outlier.”
Vaccine schedules are based on a country’s burden of disease, that country’s health system, and other country-specific factors, O’Leary adds.
“We are a unique nation in terms of the needs we have,” he says. “Our schedule was based on what worked and what’s important for the U.S. That said, we are very similar in terms of what is recommended, for example, in Canada, Germany, Ireland, Australia, New Zealand, and similar countries. Denmark’s vaccine schedule (which is similar to the new U.S. schedule) is actually the outlier.”
How will the changes affect insurance coverage for these vaccines?
Under the Affordable Care Act, insurers must pay for any vaccine categorized under shared clinical decision-making as well as those universally recommended. Insurers have committed to doing that at least through 2026, O’Leary says.
“Payers, for the most part, have said they’re going to follow the science-based recommendations coming from the professional societies,” says O’Leary. “From their perspective it makes financial sense, because it saves them money” from the reduced burden of disease.
However, vaccine recommendations could affect vaccines administered through Vaccines for Children, the federal program that provides vaccines for roughly half the nation’s children, Schaffner says.
“It hasn’t happened yet, but it’s possible that the federal government could curtail access through the program,” he says.
These decisions could have a chilling effect on the manufacture of vaccines, affecting the availability of existing vaccines and the development of new ones, Schaffner notes.
How can parents make the best vaccine decisions for their families?
Schaffner recommends that Americans continue to put their faith in their family physicians and pediatricians, whom they overwhelmingly trust most for their health care information, he says.
“Our frontline pediatricians and family doctors and their staffs are working overtime to try to answer all parents’ questions and reassure them that the vaccination of their children is the right thing to do, not only for them individually but for all the children in the community [by providing them with herd immunity],” he says.