Federal officials today announced an unprecedented overhaul of the US childhood immunization schedule, paring the number of universally recommended immunizations from 17 to 11.
The new vaccination policy, which takes effect immediately, is modeled after the schedule used by Denmark. Although the Centers for Disease Control and Prevention (CDC) will continue to recommend 11 shots for all children, six others will be recommended only for children deemed to be at high risk of infection, said the agency’s acting director, Jim O’Neill.
A third group of vaccines will be available through “shared clinical decision-making” with medical providers.
Public health experts immediately decried the change. Experts said there’s no reason to change a system that has prevented 1.1 million deaths over the past 30 years.
“Abandoning the U.S. evidence-based process is a dangerous and potentially deadly decision for Americans,” said Jason M. Goldman, MD, president of the American College of Physicians. “The evidence is clear that vaccines prevent deaths, hospitalizations, and spread of disease.”
New schedule recommends shots against 11 diseases, down from 17
The CDC will continue to recommend vaccines against 11 diseases for all children, including measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV), and varicella (chickenpox).
The CDC is recommending six shots for “high-risk groups,” including vaccines that protect against respiratory syncytial virus (RSV), hepatitis A, hepatitis B, dengue and two vaccines targeting bacterial meningitis (MenACWY and MenB). Dengue vaccines have always been targeted only to a relatively small number of children in specific circumstances.
The vaccines recommended for shared clinical decision-making are for rotavirus, COVID-19, influenza, meningococcal disease, hepatitis A, and hepatitis B.
In another important change, the CDC is now recommending only one dose of HPV vaccine. Until today, the CDC recommended two or three HPV vaccines, depending on the age at which children receive their first shot.
The new policy emphasizes that all vaccines recommended for any of the three categories will remain covered by insurance.
Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has long claimed that US children receive “too many” vaccines. Today’s announcement addresses his long-held wish to reduce the number of immunizations that children receive.
It also fulfills a directive issued by President Donald Trump last month calling for HHS to align the US vaccination schedule with that of Denmark and other countries that recommend fewer vaccines. The CDC said the changes followed an assessment of 20 developed nations, most of which have national health care systems that provide free health care to their citizens from birth to death.
Experts say changes are radical, dangerous
“This is a very dark day for children and for their parents and for our country generally,” said Jesse Goodman, MD, MPH, a professor of medicine and infectious diseases at Georgetown University, who spoke at a press conference of vaccine experts following the announcement.
Goodman compared the announcement to a “torpedo” blowing up vaccination policy. “There will be more diseases, more infection, more hospitalization,” said Goodman, a former Food and Drug Administration (FDA) chief scientist and former director of the agency’s center for biologics evaluation and research.
Officials with the American Academy of Pediatrics (AAP), which has not changed its childhood vaccination recommendations, also oppose the new schedule. Many pediatricians and family doctors tell CIDRAP News that they will continue to follow AAP’s guidance, rather than that of the CDC.
This is a very dark day for children and for their parents and for our country generally....There will be more diseases, more infection, more hospitalization.
“I’m not sure why they want to bring the diseases back but that’s their goal,” said Sean O’ Leary, MD, who chairs the AAP’s infectious disease committee, during a separate press conference held after the announcement. “With RSV we’ve already seen population-level impact. Why do they want more hospitalizations? Hepatitis A is a miserable disease, and it’s particularly bad as children age.”
Michael Osterholm, PhD, MPH, of the Vaccine Integrity Project and the director of the University of Minnesota's Center for Infectious Disease Research and Policy (CIDRAP), which publishes CIDRAP News, called today’s announcement a radical move.
“Eliminating vital US childhood vaccine recommendations without public discussion or transparent review of the data the decision was based on is a radical and dangerous decision,” Osterholm said. “This wildly irresponsible decision will put lives at risk.”
Eying a return of vaccine-preventable diseases
The changes to the childhood immunization schedule come as more US children are dying from vaccine-preventable diseases, which have returned as immunization rates have declined.
Two Texas children died from measles last year in an outbreak that has reached more than 2,000 cases and shows no sign of stopping. Thirteen people died from pertussis, also known as whooping cough, which infected nearly 28,000 Americans last year.
The United States also recorded at least 288 flu deaths in children last year, the highest number for a non-pandemic flu season. Several children already have died of flu this year, in what is predicted to be a severe influenza season.
“Given the intensity of the current flu season and this guidance from the political appointees at HHS, it seems likely we will see even more deaths this year,” Kevin Ault, MD, a professor of obstetrics and gynecology at the Western Michigan University Homer Stryker School of Medicine.
“Making these changes amid ongoing outbreaks of vaccine-preventable diseases shows a disregard for the real confusion families already face,” Infectious Diseases Society of America President Ronald Nahass, MD, said in a statement.
During the AAP press conference, O’Leary said the emphasis on shared clinical decision-making will only further confuse both parents and doctors.
“The fact is, pediatricians already do this all day, every day,” he said. “It just makes things more confusing for parents and clinicians. So when the evidence is clear that the benefits outweigh the risks, the guidance should be clear, not confusing as what has now happened today.”
Changes likely to be challenged in court
The Trump administration has circumvented the usual process for updating vaccine schedules, which normally involves input from scientific experts, public health leaders, and other stakeholders, Ault said.
An 80-year-old law called the Administrative Procedures Act requires that federal officials follow an open, deliberative process when issuing rules and regulations. The law forbids federal officials from making decisions that are “arbitrary and capricious.”
The AAP already filed a lawsuit against Kennedy in July, claiming that he violated the APA when he issued a directive removing the COVID-19 vaccine from the CDC immunization schedule for children and pregnant women.
Eliminating vital US childhood vaccine recommendations without public discussion or transparent review of the data the decision was based on is a radical and dangerous decision.
For vaccines, that process typically includes public meetings by ACIP, which makes vaccine recommendations which the CDC director can accept or reject. These meetings are announced in advance, with opportunity for written comments ahead of the meeting, as well as time for the public to speak during the meeting.
“For decades, changes in the American vaccine have been discussed in public meetings at the CDC with expert review of the available evidence,” said Ault, a former member of ACIP. “The new guidelines are not supported by data, and there was no input from stakeholder groups like the American Academy of Pediatrics and the American Academy of Family Physicians.”
“The goal of this administration is to make vaccines optional,” said Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia. “I think that’s where we’ve been moving.”
