US left without functioning vaccine panel as adviser says ‘drama distracts’

Amid upheaval to the US vaccine advisory committee Robert Malone, the former co-chair and controversial figure who has opposed vaccines, says he has been pushed out and will not be involved in any future decisions. The move comes after a federal judge stayed the appointment of 13 members of the Advisory Committee on Immunization Practices (ACIP), essentially invalidating their roles on the committee and the decisions they have made.Those new advisers were all hand-picked by the Department of Health and Human Services (HHS) secretary, Robert F Kennedy Jr, after he fired the previous 17 members of the ACIP in June – but the judge ruled they were unqualified and not selected properly.The US now has no functioning advisory committee, and several key vaccines are no longer recommended, including the latest version of flu and Covid shots and the inclusion of the RSV shot for infants in the federal Vaccines for Children program, which covers immunizations for more than half of US children.Donald Trump is also expected to name a new director of the US Centers for Disease Control and Prevention (CDC) on Wednesday. He is required to name a new head of the agency within 210 days of the previous director leaving, or acting directors are no longer able to carry out their work. The current acting director, Jay Bhattacharya, is the fourth leader in a year of the embattled agency, and he also runs the National Institutes of Health (NIH).“I am done with the CDC and ACIP,” Malone told Roll Call on Tuesday, adding: “Suffice to say I do not like drama, and have better things to do.” He attributed the decision to unpaid labor, “incredible hate”, and “sabotage”, among other reasons, in a message to the New York Times, saying: “If offered the opportunity to participate in a relaunched ACIP, I will respectfully decline.”After Malone claimed last week that the ACIP had been “disbanded” and would be reconstituted, Andrew Nixon, the HHS spokesperson, rejected those statements, telling the Guardian in a statement that “unless officially announced by us, any assertions about what we are doing next is baseless speculation.” Malone told Roll Call that Nixon “trashing” him in the press was “the last straw”.Nixon referred the Guardian to comments from Martin Kulldorff, the former chair of the ACIP who now serves as chief science officer for the office of the assistant secretary for planning and evaluation at HHS: “In light of the court ruling and the enormous amount of volunteer time provided by ACIP members to enhance public health, I can sympathize with his decision to step away. As for Andrew Nixon, I found him to be professional and honest in all his work supporting ACIP.”Malone has incorrectly claimed that vaccines are dangerous and ineffective; at one point, he was banned from Twitter for allegedly spreading misinformation. In the most recent ACIP meeting in December, he frequently interrupted other advisers and outside experts, and he raised doubts about the vaccination schedule.“The specific elephant, in this case, has to do with cumulative risk across the entire childhood vaccine schedule, and that is a risk for which we do not have adequate data,” he said – a claim disputed by the CDC’s own data.“It is good that Dr Malone wishes now to decrease drama regarding vaccines,” which “contrasts” with his prior statements, said Joseph Hibbeln, a psychiatrist and nutritional neuroscientist who was also appointed to the committee in June. “No one has been asked to be appointed to any new ACIP,” Hibbeln added.The HHS is reportedly planning to add new members to the vaccine committee, a process that takes about four to six months. In the meantime, while the routine childhood vaccine schedule has been restored, some vaccines remain in limbo – especially flu and Covid shots that are updated annually and receive new recommendations each time.Those immunizations remain on the market, but in some states, pharmacists may be wary of administering them. Physicians and pharmacists are protected from liability around administering the Covid vaccines under the Prep Act as long as they are recommended by the CDC and ACIP. Some states allow pharmacists to give shots that are recognized by outside organizations like the American Academy of Pediatrics (AAP), giving them the authority and protection from liability in administering shots – but some states have limits on pharmacy administration if the ACIP does not recommend the shots.Nixon has indicated that the US government intends to appeal, telling the Guardian shortly after the decision came down that “HHS looks forward to this judge’s decision being overturned just like his other attempts to keep the Trump administration from governing.” But no official announcement has been made on the prospect of an appeal.“We will challenge anything short of a qualified committee selected through the proper process,” said Richard Hughes IV, a lawyer for the firm representing the AAP in the lawsuit against the federal government.Hibbeln welcomed the shift to evidence-based decisions.“It is better to make public health decisions based on data, not drama,” Hibbeln said. “Drama distracts from the real enemy, which is the new mutation that makes Covid look like a joke, or the new virus creating a new pandemic.”Officials needed to invest in research for messenger RNA (mRNA) vaccines, which can be flexible and easily adapted for new pathogens, as well as other vaccines in order to prepare for the next pandemic, he said. “The real enemy is the unknown virus that creates the next pandemic.”