In sweeping changes to the childhood vaccine schedule, the Centers for Disease Control and Prevention no longer recommends universal vaccination against six diseases. In justifying the move, health officials made misleading claims about vaccine safety while downplaying or omitting benefits.
In signing a Jan. 5 memo, CDC Acting Director Jim O’Neill eliminated routine childhood recommendations for vaccines against four diseases: rotavirus, hepatitis A, meningococcal disease and influenza. We’ll assess the rationale for the change for those vaccines. Previously, O’Neill accepted proposals to end the universal recommendation for hepatitis B and COVID-19 vaccination. We previously addressed misleading and unfounded claims about those shots.
The CDC now recommends all children receive vaccines targeting 11 diseases, down from 17 just a few months ago.
The latest changes came after President Donald Trump asked O’Neill and Health and Human Services Secretary Robert F. Kennedy Jr. on Dec. 5 to review vaccine schedules of “peer, developed countries” and consider “aligning” the U.S. schedule with them.
“After an exhaustive review of the evidence, we are aligning the U.S. childhood vaccine schedule with international consensus while strengthening transparency and informed consent,” Kennedy said in a Jan. 5 press release announcing the changes.
However, as we have written previously, vaccine schedules among high-income nations are quite similar. In recommending vaccination against just 11 diseases, the U.S. childhood schedule now universally targets fewer diseases than nearly all other “peer nations,” as defined in a table cited in the HHS memo, with the sole exception of Denmark.
The Jan. 5 memo bypassed the CDC’s Advisory Committee on Immunization Practices. This group for many years followed a formal, evidence-based process — occurring over months and involving experts with multiple specialties — to assess potential changes to the vaccine schedule. Findings were presented to experts and the public in advance of making changes.
To justify the recent changes, HHS officials instead cited a 33-page assessment prepared by two political appointees: Dr. Tracy Beth Høeg, a doctor specializing in sports medicine who is acting director of the Food and Drug Administration’s drugs division; and Martin Kulldorff, a biostatistician and epidemiologist whose appointment to an HHS leadership role was announced last month. Kulldorff was formerly the chair of ACIP after Kennedy reconstituted the committee in June.
O’Neill was chosen for his CDC role after the prior director was fired following clashes with Kennedy over the vaccine schedule.
“You basically have a group of federal appointees going behind closed doors and making recommendations about a vaccine — without any input from the public, without any input from experts in the field — and just making up their own schedule,” Dr. Paul Offit, a pediatrician and vaccine expert at Children’s Hospital of Philadelphia, told us.
The six vaccines dropped from universal recommendations are now recommended under shared clinical decision-making, which means that people may still get these vaccines after a discussion with a health care provider. (Surveys done by the University of Pennsylvania’s Annenberg Public Policy Center, our parent organization, found some misunderstanding of the term among the public.) This designation was previously used for uncommon cases where a vaccine was “not recommended for everyone in a particular age group or everyone in an identifiable risk group,” according to the CDC. There remain stronger recommendations that children with certain risk factors get hepatitis A, hepatitis B and meningococcal disease vaccines.
For the time being, the changes largely do not alter whether insurers cover vaccination, and the affected vaccines should be available at no cost, according to a review from KFF, a nonpartisan health policy organization.
We asked HHS a variety of questions, including why the normal process for changing the vaccine schedule was not followed. Press Secretary Emily G. Hilliard described Trump’s memo asking for a review of vaccination recommendations. “The updated CDC childhood immunization schedule reflects the results of that thorough review and preserves access and insurance coverage to all vaccines currently available to American children and adolescents,” she said.
Rotavirus
Rotavirus is a gastrointestinal infection that causes diarrhea, vomiting and fever and can lead to dangerous dehydration. According to the analysis in the HHS assessment, 17 out of 20 peer nations routinely recommend vaccination against the disease.
In justifying no longer recommending rotavirus vaccines routinely, HHS officials deemphasized the significant number of hospitalizations the vaccines prevent while also minimizing the number of children the virus previously killed.
“In the U.S., it can cause hospitalization for gastroenteritis, but the virus poses almost no risk of either mortality or chronic morbidity,” the assessment and memo both said.
Offit, the vaccine expert from CHOP, told us that the suffering caused by rotavirus was significant. Offit co-invented one of the two available rotavirus vaccines.
Prior to the 2006 CDC recommendation to vaccinate all babies against the disease using an oral vaccine beginning at 2 months of age, around 55,000 to 70,000 children were hospitalized each year due to rotavirus, according to a 2018 review by CDC researchers.
“It’s very hard for parents to rehydrate their child orally when the child is constantly vomiting,” Offit told us, recalling that before rotavirus vaccines were available, his hospital during his pediatric residency saw around 400 inpatients with severe dehydration from rotavirus each year. He also saw a previously healthy nine-month-old girl die of the disease. Today, he said, “most pediatric residents at our hospital have never seen an inpatient with rotavirus dehydration.”
Vaccination not only lowers the risk of hospitalization in vaccinated people, the CDC review noted, but it also lowers transmission and, therefore, the risk of hospitalization in those who are not vaccinated.
The assessment went on to give low estimates of rotavirus deaths in the pre-vaccine era. “Data from CDC indicate that among all U.S. children <15 years of age, there were an average of 3.3 deaths per year with the rotavirus diagnostic code listed on the death certificate between 1999 and 2005,” they wrote, citing a CDC database.
The 2018 review by CDC researchers estimated 20 to 60 deaths from rotavirus annually before the vaccines were recommended.
The assessment’s approach of estimating deaths relies on the deaths being recorded using a specific code, Offit said. “That’s a fairly blunt tool and no doubt is an underestimate,” he said. An HHS spokesperson did not answer a question on why the assessment estimated rotavirus deaths in this way.
Meningococcal Disease
Since 2005, the CDC has universally recommended a vaccine, MenACWY, at age 11 or 12 that targets four subtypes of meningococcal bacteria to protect against meningitis and sepsis. These infections are rare but are very serious and can be fatal. In 2010, the agency added a universal recommendation for a booster dose at age 16. (A separate vaccine exists for meningococcal type B bacteria, but it has not been recommended for all children in the U.S.)
Under the new changes, the MenACWY vaccine is now recommended for all kids only under shared clinical decision-making. For high-risk groups, including those with certain medical conditions, college freshmen living in residential housing or those traveling to certain countries, the vaccine remains fully recommended.
The cited rationale for removing the universal recommendation was primarily that the disease incidence is low, currently around 0.12 cases per 100,000 people. The memo and assessment particularly cited World Health Organization guidelines, which advise widespread vaccination when the incidence is 2 cases per 100,000 or higher. The HHS documents also pointed to a country comparison to suggest that universal vaccination programs have not driven down disease rates and noted that not all peer countries recommend meningococcal vaccination for all children.
“The incidence of meningococcal disease has declined during the past decades, both in countries with and without the routine vaccine recommendations for children, and the magnitude of the decline appears to be independent of vaccination policy,” the memo said.
While there isn’t universal agreement on routine meningococcal vaccination, most high-income countries do recommend the shots — even though their disease incidence is also low. According to the health officials’ own count, 15 out of 20 peer nations have a recommendation for all children, while five have a risk-based recommendation. Some nations, such as Germany, Switzerland and the U.K., now routinely recommend two different meningococcal vaccines during childhood.
Meningococcal disease is indeed rare in the U.S. But several experts told us this is not a reason to stop vaccinating. They also disputed the suggestion that vaccination hasn’t helped to lower disease incidence.
“Every parent should want to prevent this disease in their children,” Dr. David S. Stephens, an expert on bacterial meningitis at Emory University, told us, noting the seriousness of meningococcal disease.
Even with antibiotics and proper medical care, around 15% of patients die and as many as 20% are left with after-effects of the illness, including amputations, neurologic disabilities and hearing loss, according to a 2020 summary report of ACIP’s recommendations for meningococcal vaccines.
“[L]ow incidence in the context of a vaccination program is what we want,” Stephens said in an email. “Even though polio is very low in the US we still recommend routine vaccination.”
Stephens, who is a member of the expert panels advising the WHO and the CDC on meningococcal vaccination, noted that the disease is more common among adolescents and young adults than in the general population and that the incidence can fluctuate. CDC data show that in recent years, infections have surged, with 2024 posting 503 confirmed or probable cases of meningococcal disease — the highest number since 2013. Antibiotic resistance is also increasingly a problem.
Stephens said that the vaccination program has helped reduce disease incidence and that the MenACWY vaccines in particular provide “significant ‘herd’ protection to the unvaccinated.” He said the cited country comparison “has no bearing on the question of meningococcal vaccine effectiveness.”
“It is well known that the disease incidence began to decline before the introduction of the meningococcal vaccine, however, there is evidence that the decline was faster after the introduction of the vaccines,” Dr. Jaime Fergie, an infectious diseases specialist with Driscoll Children’s Hospital in Texas, told us, citing a 2020 paper.
He added that a 2024 modeling study estimated that through 2021, vaccination in the U.S. prevented 500 cases of invasive meningococcal diseases and 54 deaths of people 11 to 23 years of age. Without vaccination, invasive meningococcal disease incidence “would have been at least 59% higher than reported,” the study concluded.
The HHS memo also misleadingly noted that the current meningococcal vaccines “were not evaluated in large-scale double-blind placebo-controlled randomized trials before FDA approval.”
While true, Caroline Trotter, infectious disease epidemiologist at the University of Cambridge who specializes in vaccine-preventable bacterial meningitis and also advises the WHO on meningococcal vaccination, told us this is “because such studies were not ethical (because of the existence of already licensed polysaccharide vaccines for MenACWY) or feasible (given the large numbers that would have to be recruited).”
When vaccines that protect against a disease already exist, it’s unethical to test newer versions against a saline placebo, since the control group would have to forgo any protection.
“There is compelling evidence from a range of different settings, including the UK, that meningococcal vaccines are safe and effective,” she added.
“The change in schedule will increase vaccine disparities, we are also likely to see the return of this disease in more adolescents, young adults, and others over the next decade,” Stephens said.
Influenza
The CDC first recommended annual flu shots for all children 6 months and older in 2008, when it expanded the recommendation to include school-aged children 5 to 18 years old. The agency had already recommended the shot for children under the age of 2 in 2004 and children below the age of 5 in 2006.
According to the published ACIP recommendation, the decision was based on “accumulated evidence” of the vaccine’s safety and effectiveness in school-aged kids, “increased evidence” of flu’s “substantial adverse impacts among school-aged children and their contacts,” and “an expectation” that the simpler recommendation would boost vaccine uptake among kids who were at higher risk of severe disease or were in contact with such individuals. About half of school-aged children were in that category and were already recommended to get vaccinated.
Children below the age of 5 and those with certain chronic conditions are at higher risk for flu complications such as pneumonia, according to the agency, but healthy older children can also get seriously ill.
Death is rare, but does occur. Since the 2004-2005 flu season, reported pediatric flu deaths, which are likely an undercount of the true number of deaths, have averaged 137 a year when excluding the 2020-2021 season during the COVID-19 pandemic. Last year’s flu season was rough, however, and 289 children died — the most since the agency began tracking deaths over two decades ago. More than 40% of those children did not have underlying medical conditions, and nearly 90% had not been fully vaccinated. This year is also shaping up to be an unusually bad flu season.
In explaining why they no longer recommended universal flu vaccination for kids, health officials pointed to the lack of randomized controlled trial data showing a hospitalization or death benefit of flu vaccination in children.
“The trials could not evaluate differences in hospitalizations or mortality, as there were none or few in either group, so they provide no evidence that the vaccines reduce hospitalization or deaths,” the memo said, citing a 2018 Cochrane review, which the health officials called the “most comprehensive review.”
The memo also dismissed observational studies, calling one particular type of study — the test-negative case-control study — “a notoriously biased study design with highly implausible results,” and the memo referred to a “scarcity of reliable safety data.”
In an interview with CBS News on Jan. 7, HHS Secretary Kennedy also cited the Cochrane review when he said it may be “better” if fewer kids receive the flu vaccine as a result of the new policy. “They found that there is no evidence that the flu vaccine prevents serious disease or that it prevents hospitalizations or death in children,” he said, referring to the Cochrane authors. “There’s no scientific evidence. And what we tried to do is to follow the science.”
Experts, however, say this is misleading.
The Cochrane review, which focused almost exclusively on randomized controlled trials, did not identify hospitalization or death benefits of flu vaccination, but it also did not include any trials with data on those outcomes. It did, notably, find evidence that flu shots worked to reduce influenza in children.
Dr. Mark Loeb, an infectious diseases specialist at McMaster University in Canada who has studied flu vaccines, told us that one of the limitations of randomized controlled trials is that they are not practical to use to evaluate outcomes that are rare, such as hospitalization or death in this case. “Because the outcomes are very rare” in healthy kids, he said of influenza, “you’d need millions of people in a randomized controlled trial.”
This does not mean that flu vaccines don’t work to prevent severe outcomes, but that randomized trials are not an ideal way to measure those potential benefits. Loeb said that he primarily conducts randomized trials — and thinks such trials should be done whenever possible — but not in this case.
“The HHS Decision Memo ignores the fact that clinical trials are not powered to detect rare outcomes such as hospitalization and death,” Dr. Edward Belongia, a global expert on flu vaccine effectiveness who retired from the Marshfield Clinic Research Institute in Wisconsin last year, told us in an email. “Post-licensure observational studies are needed to provide valid estimates of influenza vaccine protection in the real world, including protection against serious outcomes.”
Contrary to HHS’ claim that test-negative case-control studies are “notoriously biased,” Loeb said they were “one of the most rigorous forms of observational studies.”
Belongia said the test-negative design “is the current gold standard” for observational studies of influenza vaccine effectiveness, noting that it “has been directly compared with clinical trial data and shown to generate comparable results.”
In such studies, patients needing medical care for respiratory illness are enrolled in the study and then tested for influenza, Belongia explained. Vaccine effectiveness can then be estimated based on the number of “case” patients who test positive for flu compared with the number of control patients who test negative. “An important advantage of this design is that it inherently controls for bias due to differences in health care seeking behavior,” he said.
“Like the Cochrane review authors, the HHS Decision Memo ignores a large body of evidence that influenza vaccines are effective in children, including substantial protection against severe illness,” Belongia added, citing multiple papers.
A review published in the New England Journal of Medicine in October, for example, which looked at the evidence since ACIP’s last review of the subject a few years ago, identified a vaccine effectiveness of 67% in preventing pediatric hospitalization. Another study, assessing vaccine effectiveness during the 2015-2016 season, found vaccination was 56% effective against hospitalization in children.
Last year, Loeb also published a review of test-negative studies on flu vaccination, which concluded that “[s]easonal influenza vaccination moderately reduces severe influenza-related outcomes, particularly in children.”
As for safety, Loeb said that unless a person has had a severe allergic reaction to a previous flu shot, the vaccine is a “very safe” vaccine. “There is a large amount of safety data,” he said, and “very good evidence” that the benefits “greatly outweigh” the risks.
Hepatitis A
The hepatitis A virus infects the liver, in rare cases causing liver failure and death. HHS officials emphasized the low incidence and death rate from hepatitis A, while making misleading claims about the safety of hepatitis A vaccines.
Hepatitis A vaccination was first recommended for some children in 1996 and eventually universally recommended in 2006 starting at 12 months of age. Now, the vaccines are recommended for all kids only after discussion with a doctor, although they are still fully recommended for kids traveling to countries with high or intermediate levels of hepatitis A, which is spread in feces.
“Given the low U.S. incidence and mortality, and the lack of randomized placebo-controlled safety data, the benefit-risk ratio is at best very low for most children,” the assessment and memo both said. An HHS spokesperson did not answer a question about what harms from hepatitis A vaccination the documents were referring to.
Dr. Noele Nelson, a physician and epidemiologist at Cornell University, told us the new recommendations are “missing the big picture” of why hepatitis A vaccination was recommended for children in the first place. Nelson was previously in leadership roles at the CDC, including as a branch chief in the viral hepatitis division.
Young children are not at high risk of death or severe illness from hepatitis A and generally have no symptoms when infected, but they do transmit the virus, Nelson explained. Those at higher risk of severe disease include adults over the age of 40 and people with certain health conditions.
Children can shed the hepatitis A virus in their stool for months, and it can remain infectious on surfaces for months, according to a 2020 report co-authored by Nelson, which summarized a review of hepatitis A vaccination by ACIP. Children “can transmit in daycare centers, they can transmit in schools, they can transmit to caretakers,” Nelson told us. It “used to be children in diapers were the ones who were spreading it to susceptible adults,” she said. If vaccination rates go down substantially, “it’s very conceivable that you would start to see that again.”
Vaccinating kids against hepatitis A both prevents them from spreading the virus and protects them into adulthood, as the vaccine “has long-term effectiveness and likely confers lifetime immunity, really one of the marvels of vaccinology,” Nelson added.
The HHS assessment and memo also cast doubt on the safety of the hepatitis A vaccines, misleadingly claiming that “without a proper placebo-controlled randomized trial, reliable safety data is limited.”
As we’ve written in the past, this is an anti-vaccine trope that relies on a very narrow definition of a proper clinical trial and dismisses other types of studies that can be used to help establish vaccine safety.
The clinical trials testing the hepatitis A vaccines “were incredibly successful, with no severe adverse events noted,” Nelson said, adding that in her judgment they were “done properly.” Furthermore, she said, data on vaccine safety are regularly reviewed, including by ACIP for the 2020 review and update she participated in. “Again, there were no concerning or unexpected safety findings,” she said.
One randomized, placebo-controlled trial that the assessment did not consider “proper” in their assessment compared a hepatitis A vaccine to a vaccine diluent. This contained an aluminum adjuvant, used in hepatitis A vaccines to stimulate a better immune response, as well as a preservative formerly used in the vaccines. These vaccine ingredients have a proven safety record. A second trial used a hepatitis B vaccine as a control.
Vaccinologist John Grabenstein, formerly head of medical affairs at Merck, told Science that it is common to use such controls in vaccine clinical trials. Merck’s hepatitis A vaccine, for example, he said, was compared to the diluent so that the trial could remain blinded and people would be less likely to tell whether they had been given the vaccine.
The other vaccine, made by GSK, was compared with a hepatitis B vaccine in a clinical trial in Thailand because the researchers wanted to ensure all children got some benefit from enrolling, the Science article explained. Using the hepatitis B vaccine in the control group also helped the trial remain blinded, Nelson told us.
She said that regardless of which groups they were assigned to, the participants in the trials only experienced “common, expected reactions,” such as pain at the injection site and fever. She added it was difficult to see, “even if those studies were done differently, how that would have changed the findings.”
Offering universal hepatitis A vaccination for children is a relatively uncommon practice among high-income nations. Among the 20 peer nations in the assessment, just one — Greece — had a universal hepatitis A vaccine recommendation.
However, stopping hepatitis A vaccination in childhood has risks, Nelson said. There are currently adults who are too old to have been routinely vaccinated as children but who grew up at a time when childhood infection was becoming less common. As a result, many don’t have immunity from past infection. Because infection is riskier when people are older, this group of people is now at risk of severe disease.
The problem with “not vaccinating children, when you still have circulating virus in the population and continued threats from food and threats from travel, is that you can increase the number of children with hepatitis A, which can then increase the number of adults,” Nelson said. Then “you really start to see this increase in morbidity and mortality, hospitalizations, and cost and burden on health care.”
In addition, children who never get vaccinated and who avoid infection will be susceptible to infection and severe disease as they age.
Low rates of hepatitis are “not a reason to stop vaccinating,” Nelson said, “because as soon as you let your guard down, or let that susceptible population increase, then you open yourself up to disease.”
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