CDC slashes vaccines recommended for all kids : Shots

In an unprecedented change, the Centers for Disease Control and Prevention is reducing the number of immunizations routinely recommended for all children from 17 to 11.

On the new schedule, vaccines that had previously been recommended for all children — such as those for rotavirus, hepatitis A and B, meningitis and seasonal flu — are now more restricted. They are recommended only for those at high risk or after consultation with a health care provider, a category called “shared decision-making.”

Health Secretary Robert F. Kennedy Jr. has long questioned the safety and effectiveness of many childhood vaccines. With this overhaul, the administration is taking a dramatic step to pare down the schedule of immunizations routinely recommended for all children.

The revamp follows a presidential memorandum that directed the Department of Health and Human Services and the CDC to compare the list of vaccines recommended for children in the U.S. with those in “peer, developed countries.” That memo came out Dec. 5, the same day that vaccine advisers voted to drop the recommendation that all newborns receive a hepatitis B vaccine on the day of birth.

The advisers also heard presentations then from a senior Food and Drug Administration (FDA) official on the merits of the vaccine schedule in Denmark, which recommends fewer vaccines than the U.S., and from a trial attorney who specializes in vaccine lawsuits, on the history of the childhood vaccine schedule.

“President Trump directed us to examine how other developed nations protect their children and to take action if they are doing better,” Kennedy said, in a press release about the changes. “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. This decision protects children, respects families, and rebuilds trust in public health.”

The changes to the schedule came after a “comprehensive scientific assessment” comparing U.S. policy with that of 20 other countries, said a senior administration health official who briefed reporters on the condition of anonymity. The assessment was authored by Martin Kulldorff, chief science officer at a unit of HHS who served briefly as chair of the CDC’s vaccine advisory committee last year, and Tracy Beth Høeg, acting director of the FDA’s Center for Drug Evaluation and Research.

The changes were made without formal public comment or input from vaccine makers, officials confirmed, circumventing the typical process in which many stakeholders, including the CDC’s Advisory Committee on Immunization Practices, weigh in on the benefits and risks of any changes to the vaccine schedule.

“Eliminating vital U.S. childhood vaccine recommendations without public discussion of the potential impacts on children in this country, or a transparent review of the data on which the changes were based, is a radical and dangerous decision,” said a statement by epidemiologist Michael Osterholm, of the Vaccine Integrity Project and director of the University of Minnesota’s Center for Infectious Disease Research and Policy. “This wildly irresponsible decision will sow further doubt and confusion among parents and put children’s lives at risk.”

Senior HHS officials at the briefing cited “a drop in vaccine uptake of routine vaccinations for children,” including declining measles vaccination rates, as evidence of declining public trust in vaccines. They said the changes were intended to increase public confidence in the vaccine schedule.

As no vaccines were taken off the schedule, only shifted in status, they said the vaccines would still be free and available to anybody who wants them, covered by insurance through the process of shared clinical decision-making — if a patient (or guardian) and their health care provider decide together they should get it.

HHS officials also said they would be embarking on placebo-controlled trials looking at the timing of vaccines and their long-term effects. Trials have already begun at the CDC and are being initiated at the FDA and the National Institutes of Health, they said. The officials did not provide specifics on the cost or timing of these trials but expected that the trials would require follow-up for “many, many years” and take “quite some time.”