Vaccine experts at the Centers for Disease Control and Prevention were blindsided by a top deputy to Health Secretary Robert F. Kennedy Jr.’s decision to unilaterally overhaul the childhood immunization schedule, according to current and former agency staff.
U.S. health officials took the unprecedented action Monday to narrow the list of vaccines that the federal government routinely recommends for all children, a shift that leading public health experts and medical organizations warned could weaken protections against preventable deadly diseases.
The change, which took effect immediately, means the CDC no longer broadly recommends immunization for influenza, rotavirus, hepatitis A and certain meningococcal diseases that cause meningitis. Instead, these vaccinations will be advised only for smaller groups of children and babies considered at higher risk or if a doctor recommends it. Trump administration health officials said the revised schedule more closely resembles recommendations in other high-income countries and would build trust with Americans who think their children are getting too many shots, while still requiring insurance to pay for the vaccines if parents want them.
But the overhaul contradicted guidance from career scientists who prepared a presentation outlining how the U.S. vaccine policy is not an international outlier, according to a copy of the presentation obtained by The Washington Post. Five career scientists and researchers, who spoke on the condition of anonymity for fear of retaliation, said they are angered by the bypassing of expertise in Monday’s decision. That process to alter vaccine recommendations, they and several former health officials said, did not include extensive consultation with the agency’s subject matter experts or the CDC’s vaccine advisory panel that is usually done.
“The abrupt replacement of the immunization schedule by one designed for another context and healthcare system has been done with no scientific justification,” Demetre Daskalakis, a former director of the agency’s center on immunization and respiratory diseases, said in a message. He and two other senior leaders resigned last August, citing political interference in the vaccine recommendation process.
The Trump administration’s scientific assessment accompanying the changes to vaccine recommendations doesn’t reference disease epidemiology or modeling to justify the shift in the schedule, Daskalakis said.
The sidestepping of agency expertise and traditional processes of revisions to childhood vaccine recommendations has prompted the resignation of one agency physician whose responsibilities included changes to the immunization schedule, according to two scientists who were in direct contact with her this week. The physician, A. Patricia Wodi, did not immediately return a request for comment.
Asked about the criticisms from career scientists, Department of Health and Human Services spokesman Andrew Nixon cited surveys showing declining trust in hospitals and physicians after the coronavirus pandemic.
“Pandemic era distrust of public health agencies has since spilled over into broader vaccine concerns,” Nixon said in an email. “It is clear 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.”
Deputy Health Secretary and acting CDC director Jim O’Neill, who unlike previous CDC directors, is not a scientist, said he signed a decision memo changing the schedule that was presented by Food and Drug Administration Commissioner Marty Makary, National Institutes of Health Director Jay Bhattacharya and Centers for Medicare and Medicaid Services Administrator Mehmet Oz, according to an HHS press release. President Donald Trump, who ordered the review, and Kennedy, a longtime critic of the childhood vaccine schedule, also praised the change.
Senior health officials, speaking during a briefing with reporters on the ground rule that they not be named, said they made the decision to cut the number of vaccines recommended for every child after consulting experts at the CDC, FDA and NIH.
In the second week of December, CDC experts were asked to provide information about the burden of disease and vaccine effectiveness for certain vaccines as part of the preparation for the comparison country briefing, according to a CDC scientist. The request was specific to vaccines that on Monday the administration announced it would no longer broadly recommend, the scientist said.
“We didn’t know that was the plan at the time,” the scientist said.
Experts provided the requested information but there was no briefing or follow-up, the scientist said.
Trump administration officials first planned on Dec. 19 to announce the rollback in child vaccine recommendations to align with Denmark’s immunization model, people familiar with the plan previously told The Post. But the news conference was abruptly called off.
The day before that planned announcement, CDC experts briefed HHS officials, including O’Neill, on how the U.S. vaccine schedule compares to other developed countries.
The U.S. is more similar to Germany, Japan, Canada and Australia in the pathogens it targets for immunization than to Denmark, according to their 31-page slide presentation. Japan targets 14 pathogens, Australia 15, Germany 16, Canada and the U.S. both target 17 pathogens. By contrast, Denmark’s schedule targets 10 pathogens.
The total number of vaccine doses recommended by the U.S. and those four countries is also similar. Excluding annual flu shots, Japan gives a total of 43 vaccine doses; Germany and Canada give 45 doses; Australia gives 46 doses and the U.S. gives 49 total doses, according to the CDC presentation. Denmark gives 30 doses.
Jake Scott, an infectious-diseases physician and clinical associate professor at Stanford University, said Denmark is the outlier, with one of the most minimal vaccine schedules among developed countries.
Scott said other high-income countries are moving to adopt more vaccinations like the U.S., noting that last October, Denmark began offering free vaccination against RSV for pregnant women and Britain is adding chicken pox this year.
The HHS assessment recommending fewer vaccines — authored by Tracy Beth Hoeg and Martin Kulldorff, who were prominent critics of coronavirus vaccination before joining the department — contains no new safety data, Scott said. But he said their report takes the same vaccines that have decades of safety monitoring “and reaches a different conclusion, not because the evidence changed, but because the people interpreting it changed.”
One CDC scientist who works on vaccines said career staff were “blindsided” by Monday’s announcement of a revised schedule. Another CDC scientist who works on vaccines said “none of us had any idea this was happening yesterday, and only learned when we heard people had been invited” to an HHS briefing for reporters to explain the new vaccine policy.
The new vaccine recommendations also came without consulting the CDC’s Advisory Committee on Immunization Practices (ACIP). That panel of medical professionals and experts outside the government is supposed to evaluate vaccine safety and effectiveness data to inform recommendations. It typically holds days-long public meetings and, in coordination with CDC staff, conducts extensive reviews of benefits and risks before voting to change a recommendation for a vaccine already on the schedule.
The snub of ACIP surprised some health policy experts because the committee is filled with allies of Kennedy after he fired every member last summer and replaced them with his own choices, many of whom had histories of criticizing vaccine guidance.
Kirk Milhoan, a pediatric cardiologist who chairs the panel, did not return a request for comment. Robert Malone, the committee’s vice chair and a prominent critic of coronavirus vaccines, said he did not feel like the panel was sidelined. “It was the choice of the president and of the secretary to approach it this way, and that’s entirely their prerogative,” Malone said.
Joseph Hibbeln, a psychiatrist and member of the panel who has become one of its dissenting voices, said he received no advance notice of the fundamental shift, raising questions about the committee’s mission if sweeping decisions are made without its input. “The work of the ACIP appears to be irrelevant,” he said.
Critics of the new schedule said the revisions lacked scientific rigor and risk undermining public health by confusing doctors and parents about the safety and value of vaccines.
David Higgins, an assistant professor of pediatrics at the University of Colorado Anschutz Medical Campus, said that HHS failed “to model or even consider the preventable harm that would result from lower vaccination coverage.”
“Every policy decision has tradeoffs, and those tradeoffs were not analyzed,” he said in a text message.
Multiple states run by Democratic governors called on their residents to disregard the new CDC guidance and reaffirmed their support for the previous childhood vaccine schedule, including Illinois, Maryland, Pennsylvania and the West Coast Health Alliance representing California, Washington, Oregon and Hawaii.
Their announcements are the latest illustration of how vaccine recommendations are fracturing along partisan lines as blue states turn to their own health departments and medical associations, including the American Academy of Pediatrics and the Infectious Diseases Society of America, to shape their immunization guidance.
Paige Winfield Cunningham and Lauren Weber contributed to this report.
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