The U.S. childhood vaccination schedule has been dramatically reduced, purportedly because, as federal health officials argued, the now-discarded schedule recommended children get far more vaccines than kids in “peer countries.”
But did it really? And has reducing the number of diseases all children are advised to be vaccinated against to 11 from 18 brought the United States in line with most other affluent countries?
Two words. No and no.
A STAT analysis of vaccine recommendations in the United States and 37 other countries suggests that while the former U.S. schedule did aim to avert more diseases than the schedules of many other countries, it did so by only a few more diseases than in multiple other nations in Europe, the Middle East, Asia, and Australasia. (The analysis drew the information from a World Health Organization database, which is based on information the WHO receives from its member countries; in the case of Taiwan, information was drawn from its department of health website.)
South Korea, an economic powerhouse, recommends all children be vaccinated against 18 diseases, as does Brazil. Greece recommends vaccines against 17 diseases.
(For the purposes of this analysis, STAT has counted antibody products that protect against respiratory syncytial virus, or RSV, towards a country’s vaccine total, if it recommends the shot for all babies.)
In fact, the pared-down U.S. vaccine schedule now aims to protect children against fewer diseases than all but one of the 20 so-called peer countries whose schedules were presented by federal health officials as the rationale for the policy change.
That sole country is Denmark, an international outlier that currently recommends vaccines to protect against only 10 diseases for all children. But the country is in the process of assessing whether to add the chickenpox vaccine to its schedule, with the Danish Health Authority’s panel of vaccine advisers voting in December to green-light a medical technology evaluation of the vaccine, according to Jens Lundgren, an infectious diseases professor at the University of Copenhagen, who is on the committee. Lundgren said a final decision will likely come in the next year or so.
The revised U.S. schedule also recommends vaccines against fewer diseases than a range of other countries including Israel, Turkey, Saudi Arabia, South Africa, Brazil, China, Taiwan, and even the West African nation of Guinea-Bissau, whose childhood vaccination schedule includes vaccines to protect against 12 childhood diseases.
The decision to carve certain vaccines out of the childhood schedule was announced Monday.
“The U.S. is a global outlier among peer nations in the number of target diseases included in its childhood vaccination schedule and in the total number of recommended vaccine doses,” said the analysis used to explain the decision, written by Tracy Beth Høeg of the Food and Drug Administration and Martin Kulldorff of the Department of Health and Human Services.
Høeg, a sports medicine doctor who studied for a time in Denmark and is a dual American-Danish citizen, is the acting director of the FDA’s Center for Drug Evaluation and Research. Kulldorff, a biostatistician and epidemiologist, was recently named chief science and data officer for the assistant secretary for planning and evaluation at HHS. Both are political appointees.
Vaccine experts disagree with their conclusions.
“They want you to believe that we’re way out of sync, and that we give way more vaccines than everybody else. But we don’t,” said Anna Durbin, director of the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health.
The 38 vaccine schedules that STAT analyzed recommended shots against an average of 14 diseases for all children. The only country that recommended vaccines against as few diseases as Denmark was Vietnam, which is in the process of adding vaccines to protect against four diseases to its childhood schedule — flu, rotavirus, human papillomavirus, and pneumococcal disease — by the end of the decade. Even among the 20 countries listed as peers in the Høeg-Kulldorff report, the average number of preventable diseases vaccinated against was 13.6.
But deciding on which vaccines to recommend for all children — which diseases and their consequences a country wants to help its children avoid — is not typically done by simply selecting a number, said William Moss, a professor of epidemiology at Hopkins and executive director of the International Vaccine Access Center.
“Just in terms of process, one could legitimately ask: Is the best way to determine the U.S. immunization schedule just by comparing it to other countries and kind of cherry-picking which country you want to follow per particular vaccine antigen?” he asked.
“Creating an immunization schedule is a complex process and there are multiple factors that play into it, including estimates of disease burden and the particular health care system,” Moss noted. “But I think it’s very important for the American public to understand that if a particular country like Denmark doesn’t include a vaccine, it’s not because they think that vaccine is harmful. It has to do with their own calculus, in their own country, their own situation.”
Anders Hviid, who heads the department of epidemiology research at the Statens Serum Institut, Denmark’s public health agency, concurred.
“You cannot adopt the public health policies of another country unless the population, health care system and prevalence of infectious diseases match,” he said in an email.
As many experts have pointed out, the differences between the demographics and disease-burden dynamics of the United States (population: 343 million) and Denmark (population: 6 million) are profound — to say nothing of the fact that the latter has an effective universal health care system.
The newly adopted U.S. schedule focuses on 11 diseases: measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (also known as Hib), pneumococcal disease, human papillomavirus (HPV), and varicella or chickenpox.
The diseases that were targeted by the vaccines Høeg and Kulldorff recommended shaving off the schedule are: rotavirus, RSV, hepatitis A and hepatitis B, influenza, meningococcal disease, and Covid-19. The Trump administration, under health secretary Robert F. Kennedy Jr., had already moved to eliminate the universal recommendation for hepatitis B vaccination, and the one recommending Covid shots for all children.
Under the new plan, the vaccines removed from the universally recommended schedule will be offered to children who are at risk of contracting the illness the vaccine protects against (RSV, hepatitis A and B, and meningococcal disease) if a way to figure out who is at risk can be determined. And all vaccines removed from the core schedule will still be available if parents want them for their children after having discussed the decision with their medical team. That’s a process called shared decision-making.
Comparing the vaccine schedules of different countries is challenging for a number of reasons. The populations of some countries are exposed to some diseases that are not common elsewhere. The Japanese encephalitis vaccine is recommended for all children in some East Asian countries — Japan and South Korea among them. Brazil recommends vaccination against yellow fever, which is not a threat in North America or Europe.
Some countries recommend HPV vaccines for girls only; some recommend both girls and boys should be vaccinated. Some recommend flu vaccine for all children, while others target certain age groups, such as schoolchildren. If a country recommended HPV vaccine for all girls, STAT counted that as a universal recommendation, and if it recommended flu vaccine for all children in an age band, that also was counted as a universal recommendation.
RSV antibodies complicate assessing differences between countries. The two approved products given to babies to protect them during their first winter are used like a vaccine. They are administered via an injection. But they are not technically vaccines; they are inoculations of antibodies that arm an infant’s immune system to fend off a virus it hasn’t yet had a chance to generate its own protection against.
In the United States, the RSV monoclonals were recommended for all children by the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention on vaccine use. The ACIP has treated the shots like a vaccine, including coverage of them in the Vaccines for Children program.
In Høeg and Kulldorff’s comparison of the U.S. schedule with those of peer nations, they do not list RSV monoclonals in their vaccine tallies.
RSV monoclonals are new, and a number of countries are still in the process of deciding whether to offer them to all their children, and how to use them in conjunction with an RSV vaccine for pregnant people that arrived on the market at about the same time the first monoclonal was approved. Antibodies generated by the vaccine pass to a fetus in the womb, giving it protection during its first few months of life.
Lundgren, from Denmark’s Vaccination Council, noted, for instance, that that country opted to vaccinate pregnant people against RSV rather than recommend the antibody shots for all babies because studies showed mothers preferred that option and the country’s strong electronic records system made it possible to determine who had been vaccinated. Babies born pre-term, whose mothers haven’t yet been vaccinated, are given monoclonals, he said.
Kate O’Brien, director of immunization, vaccination, and biologics for the WHO, said national immunization technical advisory groups juggle a range of factors when making decisions about which vaccines to recommend for all children. Cost-effectiveness. The scale of the risk. The feasibility of figuring out whether a targeted program would get the job done or a universal recommendation is needed. (The U.S. adopted the recently jettisoned policy of recommending every child get hepatitis B vaccine at birth because recommending vaccination only for children known to be at risk was missing too many babies.)
“It’s nearly impossible to predict, on an individual basis, who is the child who’s going to have whatever outcome of whatever disease. So each [immunization advisory group] has to balance these decisions,” O’Brien said.
She noted that internationally, there isn’t that much variability in the vaccines countries recommend for all their children.
It is true, though, that the United States under Kennedy takes a different approach to vaccination than it has for decades.
“It used to be very clear, from the direction of the program, that the U.S. saw itself as a program that was making an effort to optimize impact,” O’Brien said. “In other words, to prevent the most illness, to prevent the most serious outcomes, to prevent the most health harms by vaccinating.”
That has resulted in a situation where diseases that were once ubiquitous, which regularly sickened and sometimes killed babies, became for a while much less common.
“The challenge now is that individual practitioners and individual parents have the beauty, the benefit that they grew up — and their children are growing up — in a society where these diseases are rare,” she said. “And the reason that they’re rare is because these vaccines have been used. When we stop using the vaccines, these diseases are coming back. There’s no ambiguity about that.”
