The first meeting of a critical federal vaccine panel was a high-profile display of how the US health secretary and vaccine skeptic Robert F Kennedy Jr has injected chaos into vaccine policy infrastructure.
Wednesday’s meeting was held amid controversy, not only regarding the new members unilaterally appointed by Kennedy, but also the questions they would consider, their conflicts of interest and views on vaccines, and the scheduled speakers.
The new chair of the committee, former Harvard University professor of medicine Dr Martin Kulldorff, who was fired for refusing to be vaccinated against Covid-19, began the meeting by criticizing both his former employer and the media.
“Some media outlets have been very harsh on the new members of this committee,” said Kulldorff, who he said were put into “either a pro- or anti-vaccine box”.
“Such labels undermine critical scientific inquiry and it further feeds the flames of vaccines hesitancy. As Secretary Kennedy has eloquently stated, opposing mercury in fish doesn’t make you anti-fish, and opposing mercury in vaccines doesn’t make you anti-vaccines,” Kulldorff continued, referring to one of the issues the panel would consider.
Dr Martin Kulldorff and Dr Mina Zadeh, the ACIP executive secretary at the panel in Atlanta, Georgia. Photograph: Megan Varner/Reuters
Kulldorff also quickly announced the formation of two new working groups, in addition to the 11 that already serve the panel. One would study the interaction of vaccines and the cumulative childhood vaccine schedule – issues that have for years been talking points of anti-vaccine advocates including Kennedy – and another to reevaluate vaccines that have not been looked at in more than seven years. The latter would provide the committee’s new members an opportunity to change recommendations for long-approved vaccines.
The panel, the advisory committee on immunization practices (ACIP) to the Centers for Disease Control and Prevention (CDC), develops recommendations for how to administer vaccines to the American public.
The ACIP meeting is high-stakes and will be widely watched within the scientific community, as former members argue that the nation’s vaccine approval, research and distribution systems are being dismantled.
The panel’s decisions are highly influential in deciding which vaccines the CDC ultimately recommends for children and adults. In turn, those recommendations form the basis of how health insurers decide which vaccines to cover, and thus have a direct impact on the price and availability of vaccines to the American public.
Experts consider the current situation so dire that outside groups are attempting to develop a system to provide vaccines to Americans in spite of Kennedy’s attempts to disrupt the system.
“What we’re seeing today, and if this were to continue, the medical public health professionals and the entire country are no longer going to trust ACIP,” said Dr Sean O’Leary of the American Academy of Pediatrics Council on School Health. “That’s very clear.”
The panel met in spite of lack of clarity about a seemingly fundamental issue: conflicts of interest. Kennedy fired the 17 previous members of the panel after arguing they had “been plagued with persistent conflicts of interest”.
Before the presentations of the meeting started in earnest, the new members were asked to introduce themselves and verbally describe any conflicts of interest.
It’s unclear whether the new members have had conflict of interest disclosures published in writing ahead of the meeting. The new members did not appear on the Trump administration-developed conflict of interest tracker specifically for ACIP members as of Wednesday morning.
A spokesperson for the Department of Health and Human Services (HHS) told the Guardian that the new members had undergone ethics review but did not respond to inquiries about when and where these disclosures would be published. The spokesperson also said one of the eight Kennedy-appointed members had dropped out on Tuesday evening after a government financial review.
A spokesperson told the Guardian last week: “Before they start their work on ACIP, the new members’ ethics agreements will be made public.”
Some members did not address any conflicts of interest, seeming to focus only on their introduction. Others, like Kulldorff, did not disclose past involvement with litigation against vaccine makers. Similarly, Dr Robert Malone did not appear to disclose his work in the litigation against the Merck vaccine.
Cody Meissner and Vicky Pebsworth speak remotely during the ACIP meeting. Photograph: Mike Stewart/AP
Instead, Malone said: “Any potential conflicts of interest have been analyzed and vetted and declared lacking both internally by HHS and specifically by CDC.”
Vicky Pebsworth, a nurse who holds a doctorate degree and has worked for decades as the volunteer research director for one of the oldest high-profile anti-vaccine groups in the country, said she was “disclosing I hold stock to a healthcare sector fund including vaccine manufacturers; however, the amount of that stock holding is under the office of government ethics regulatory de minimus amount. I understand I therefore can fully participate in the ACIP meeting.”
The agenda for the panel was also remade before the committee met. Previously, experts on the panel were scheduled to consider a recommendation for Covid-19 boosters.
That vote was removed from the agenda – leaving experts to hear planned presentations on Covid-19, but not to vote – because the CDC was unable to hold a final working group call. It is unclear why the call was not held.
CDC scientists explained how the Covid-19 “does remain a substantial burden among youngest and oldest age groups”. After the presentations, members of the ACIP asked whether the low uptake of the vaccine – that some had actively sown doubt about – should be considered a reason not to recommend it.
“The fact [that uptake is] so low is a reflection of the lack of trust many parents have with the Covid vaccination recommendation that the ACIP has been giving,” said Kulldorff.
In another exchange, Pebsworth suggested that the CDC should be looking at “animal studies” and “reproductive toxicity” in relation to Covid-19 vaccines, arguing that only “10% of adverse events are reported”.
Dr Sarah Meyer, a researcher with the CDC’s immunization services division who presented on the topic, said the numbers referenced by Pebsworth were misleading because they included even the most minor “adverse events”, such as sore arms. “For serious reports, we are confident we get a majority of those reported” to surveillance systems such as the Vaccines Adverse Event Reporting System.
Instead, members were scheduled to only vote on whether to recommend a second monoclonal antibody, called Clesrovimab, for respiratory syncytial virus (RSV) for all infants younger than eight months old born during respiratory virus season. The vote was postponed because the meeting ran late. The committee is scheduled to meet again on Thursday.
Other advisers joining the meeting reflect the way that Kennedy has remade the federal health department. Representing the Food and Drug Administration was Tracy Beth Høeg, a sports medicine physician and epidemiologist who has called for more scrutiny of vaccines. One of the experts scheduled to present to the panel on Thursday is nurse Lyn Redwood, the ex-president of Kennedy’s anti-vaccine group Children’s Health Defense, according to Politico.
Key Republican Dr Bill Cassidy, whose vote helped assure Kennedy’s confirmation to HHS, called for the meeting of the panel to be delayed, citing the new members’ “lack of experience” with vaccines and, in some cases, “preconceived bias against them”, according to STAT News.
Further, the panel’s new agenda cited a study that the cited author said he did not conduct or publish, according to Reuters, continuing a pattern of Kennedy’s health department producing references to garbled or nonexistent studies even as Kennedy repeatedly touts “gold-standard” science.