CDC blindsided as RFK Jr. changes covid-19 vaccine recommendations

Health and Human Services Secretary Robert F. Kennedy Jr.’s surprise announcement Tuesday ending coronavirus vaccine recommendations for healthy children and pregnant women blindsided the agency that offers that advice, according to current and former federal health officials. Officials at the Centers for Disease Control and Prevention are scrambling to understand Kennedy’s decision, announced in a 58-second video on X on Tuesday morning, which took agency staff by surprise. Five hours later, CDC officials received a one-page “secretarial directive,” dated May 19 and signed by Kennedy, that contradicts some of what he said in his video, according to two current and one former health officials, who spoke on the condition of anonymity out of fear of retaliation. In his tweet and video, Kennedy said he had unilaterally decided to override the current recommendation that everyone 6 months and older receive an annual coronavirus vaccination — including healthy pregnant women. Advertisement Officials at the CDC learned of that decision “when it was tweeted. People were scrambling to find out what it meant,” one federal health official said. The letter was distributed to the CDC in the afternoon, causing more confusion because it was dated May 19, the official said. In his video, Kennedy also said federal health officials had removed the previous recommendations from the agency website. But top CDC officials did not know of the decision at the time, according to one official, and as of Wednesday that removal still had not happened for the millions of people who rely on the site for health-care guidance. The directive raises questions about who should be getting the vaccine because it refers to both healthy children and all children. “The CDC is directed to remove COVID-19 vaccines from the recommended Child and Adolescent Immunization Schedule by Age and recommended vaccines during pregnancy,” the letter states. Advertisement “It’s unclear,” the official said. In his video, Kennedy, who founded an anti-vaccine organization before joining the government, also said he was ending coronavirus shots for healthy pregnant women. But last week, top officials from the Food and Drug Administration outlined a new coronavirus vaccine policy in a New England Journal of Medicine article, approving shots only for those 65 and older and people with medical conditions that put them at high risk for severe illness. Pregnancy is listed as one of the conditions. HHS spokesman Andrew Nixon said the directive provides that the vaccine should not be recommended for healthy children under 18 and should not be recommended for pregnant women. He did not address questions about the apparent contradictions between the directive, Kennedy’s video and the New England Journal of Medicine article. Advertisement “Secretary Kennedy is taking urgent action to ensure the public’s safety when it comes to COVID-19 vaccines,” Nixon said in a statement. As of Wednesday afternoon, the CDC website on immunization of children and adolescents under 18 continued to recommend one or more doses of coronavirus vaccine for those 6 months and older. The website for pregnant women continued to recommend an updated shot for those who are pregnant, breastfeeding an infant, trying to get pregnant now or might become pregnant in the future. The bottom line, according to public health experts and agency officials, appears to be an effort by Kennedy and the Trump administration to further erode public trust in the CDC. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a longtime pediatric infectious-diseases physician, said bypassing the CDC makes it more difficult for people to access the coronavirus vaccine. Current law requires insurance companies to cover the cost of CDC-recommended vaccines without charging out-of-pocket costs to consumers. Advertisement “They’ve made it much less insurable, and therefore this could make it much less available for people,” Offit said. “It’s a continued war against vaccines by our secretary of health and human services.” “His goal is to make vaccines less available, less affordable and more feared. That’s his goal, and this is what he’s doing,” Offit said. The long-established process for vaccine approval in the United States involves the FDA and the CDC. The FDA is responsible for regulating vaccine use, including approving vaccines for safety and efficacy. Before a vaccine can be tested in people, researchers study its ability to produce an immune response in animals. If it shows promising results, it moves forward to clinical trials for testing in people, which includes monitoring for side effects and determining how well the vaccine triggers an immune response. The FDA reviews that clinical trial data before its decision. In some cases, the FDA’s vaccine advisory committee provides additional input at public hearings. The CDC’s vaccine advisory panel of medical and public health experts — the Advisory Committee on Immunization Practices (ACIP) — develops recommendations for the use of vaccines approved by the FDA. To determine the public health benefit, the panel weighs safety and vaccine effectiveness, the seriousness of the vaccine-preventable disease and the number of people who would contract the disease if there were no vaccine. After the ACIP recommends a vaccine, the CDC director must sign off for it to become official public health guidance. The CDC has no permanent director, raising questions about who is empowered to sign off on vaccine recommendations. Susan Monarez, who had previously been acting director, is awaiting Senate confirmation.