Federal vaccine panel in disarray after judge blocks changes

By Sarah Owermohle, Jen Christensen, Meg Tirrell, CNN

(CNN) — The future of the US Centers for Disease Control and Prevention’s panel of vaccine advisers is unclear, even among its recently appointed members.

On Monday, a federal judge temporarily blocked the US Department of Health and Human Services’ overhaul of the vaccine schedule and ruled that HHS Secretary Robert F. Kennedy Jr.’s decision to replace the CDC’s panel of independent vaccine experts in June did not follow federal legal procedures.

The ruling has left confusion in its wake. The panel, the Advisory Committee on Immunization Practices or ACIP, canceled its planned meeting this week.

Over several social media posts on Thursday, one of the members appointed by Kennedy, Dr. Robert Malone, said that the government will “disband and then recreate a new ACIP committee.” Hours later, Malone posted that information he had shared was a “miscommunication, and in fact the decision about how to proceed has not been made, and dissolving and reforming remains one of options being considered.”

A spokesperson for the Independent Medical Alliance told CNN that ACIP chair Dr. Kirk Milhoan, a former senior fellow with the group, was not available for comment but had also been told by an HHS official that the committee had been disbanded.

Another ACIP member, speaking on the condition of anonymity, told CNN that HHS may intend to repopulate the committee with new members, which may be a faster route than waiting out legal appeals. As part of this week’s decision, the judge also suspended the votes the committee has taken, and there are some pressing issues that may need to be acted on, the person said.

HHS spokesperson Andrew Nixon said Thursday, “Unless officially announced by us, any assertions about what we are doing next is baseless speculation.”

In his ruling Monday, US District Judge Brian E. Murphy wrote that “of the fifteen members currently on ACIP, even under the most generous reading, only six appear to have any meaningful experience in vaccines,” and he questioned the specific credentials of other members, including Malone.

“ACIP as currently constituted cannot meet, for how can a committee meet without nearly the entirety of its membership?” Murphy wrote.

However, Murphy also noted that the plaintiffs in the suit — professional groups led by the American Academy of Pediatrics – challenged the appointment of 14 ACIP members who do not include more recent appointees. That could mean some members of the panel can continue in their roles during subsequent legal challenges.

The attorney who argued the case for the AAP, Richard Hughes, said Thursday that any committee would have to meet the standards of the Federal Advisory Committee Act, which regulates how federal agencies get advice, and the Administrative Procedure Act, which regulates how they develop policies.

“Any new iteration of the committee must conform to the laws at issue in our case, including FACA, and its reconstitution must comply with the APA. Anything short of a qualified committee selected through the proper process will meet our challenge,” Hughes said in an email.

The government had argued in court that ACIP was a “purely advisory entity” and that when Kennedy decided to change the vaccine schedule without the advisers’ vote, it was within his purview.

Since 1964, all US vaccine policy has first run through ACIP, an independent panel of vaccine experts who evaluate the latest research to determine how safe and effective a vaccine is and the committee weighs in on who should get the vaccine. The CDC director is then supposed to take the committee’s advice into consideration in making a decision on whether to recommend a vaccine. Insurance companies and some states make coverage decisions based on this process.

Last year, Kennedy described the previous members of ACIP as a “rubber stamp for industry profit-taking agendas,” despite detailed disclosures of conflicts of interest. Many of his handpicked replacements have expressed anti-vaccine views.

Government lawyers also argued in court that the US vaccine recommendations had been “a high outlier in the international community.” HHS said President Donald Trump recognized a “discrepancy” and, via a memorandum in December, directed Kennedy and the CDC to review vaccine recommendations. HHS said it completed the review, and only then did the CDC make revisions to the vaccine schedule in January.

As far as the committee was concerned, Murphy’s decision said that while many of the recently appointed members “have extensive expertise in their chosen fields,” government committees that require technical expertise should “include persons with demonstrated professional or personal qualifications and experience relevant to the functions and tasks to be performed by the committee.”

This wasn’t the final decision in the case, but it is a pause on government action while the rest of the case is sorted.

AAP and several other medical groups sued the government in July after Kennedy made changes to recommendations for Covid-19 vaccines, also without input from ACIP. There’s been no final ruling on that issue specifically.

Hughes has said that appeals aren’t likely to move to another court until the rest of the case is decided.

“HHS looks forward to this judge’s decision being overturned just like his other attempts to keep the Trump administration from governing,” Nixon said in a statement after the ruling was issued Monday.

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