RFK Jr.’s HHS rewrites rules governing key CDC vaccine committee

By Brenda Goodman, CNN

(CNN) — US Health and Human Services Secretary Robert F. Kennedy Jr. has approved changes to rules that govern an expert group that advises the US Centers for Disease Control and Prevention on its vaccine recommendations.

The move, part of Kennedy’s latest effort to reshape the country’s vaccine policy, follows a March court order that temporarily blocked the work of the CDC’s Advisory Committee on Immunization Practices, or ACIP, and put some of its previous moves on hold.

The revisions significantly broaden the scope of the work that falls under the purview of the committee, which had previously limited its focus to making recommendations on the use of vaccines in the United States.

In a statement Thursday, HHS spokesperson Andrew Nixon described the renewal of the committee’s charter as “routine statutory requirements” that “do not signal any broader policy shift.”

“Unless officially announced by HHS, any assertions about next steps are speculation,” Nixon added.

Additions to the committee’s charter, or rulebook, include several points that have long been priorities of groups that advocate against the use of vaccines. The charter now puts a focus on “identifying gaps in vaccine safety research, including adverse effects following vaccination.”

The committee has also been directed to consider the “cumulative effects” of giving all recommended childhood vaccines and considering ingredients in vaccines, such as aluminum, which is added to vaccines in tiny amounts to boost the body’s immune response to them. Some vaccine skeptics believe that aluminum in vaccines may be tied to neurodevelopment problems in children, such as autism, although large studies investigating the issue have found no link.

Additionally, ACIP is now specifically tasked with considering “novel vaccine platforms such as mRNA vaccines” – the technology behind two of the Covid-19 vaccines available in the US – and reviewing the vaccine schedules used by other countries.

In August, the US Department of Health and Human Services announced that it was winding down its mRNA vaccine development activities and canceled nearly $500 million in federal funding for mRNA research and development projects, saying it was pivoting to “safer, broader” platforms “that remain effective even as viruses mutate.”

In January, HHS said it was updating the childhood immunization schedule to more closely resemble the vaccination schedules of European nations like Denmark.

“The new charter seems to try to codify the RFK vision of ACIP as a committee focused on risk only and not balance or risk and benefit,” said Dr. Demetre Daskalakis, who resigned as director of the CDC’s National Center for Immunization and Respiratory Diseases last year over changes to vaccine policy at the agency. He is now chief medical officer of Callen-Lorde Community Health Center.

Daskalakis also noted that the charter gives non-voting memberships to some medical organizations that have expressed skepticism of vaccines, saying it would give them a new platform from which to further destabilize trust in vaccines “without basis.”

Among the new non-voting liaison members are the Independent Medical Alliance, Physicians for Informed Consent and the Association of American Physicians and Surgeons, groups that maintain that vaccine risks are underreported or hidden from the public and that vaccine benefits may not outweigh their harms.

Richard Hughes, a lawyer who is representing the American Academy of Pediatrics and other medical associations in a lawsuit against Kennedy, said in a statement that the new focus on adverse events “is especially concerning, as it appears to foreground vaccine harms in a way that could further reorient ACIP’s mandate.”

ACIP was created in 1964 to study data on vaccines and make recommendations on their use for Americans.

Its recommendations, once accepted by the CDC, determine which vaccines are covered by insurance and purchased by the government for low-income children. States and school districts also look to ACIP’s recommendations to set vaccine policy, and it sets the vaccine schedule used by doctors to guide patient care.

One of Kennedy’s first acts as HHS secretary was to dismiss all 17 previous ACIP members and replace them with seven new members, several of whom had histories of exaggerating the harms of vaccines while downplaying their benefits.

Kennedy, who has long claimed that vaccines do more harm than good, complained that the previous ACIP members were biased in support of vaccine manufacturers, despite federal rules that carefully screen members for potential conflicts of interest.

Among the replacements were a pharmacist, a psychiatrist, an emergency medicine physician, three obstetrician/gynecologists, and professors of operations management and population health.

US District Judge Brian E. Murphy ruled in mid-March 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.”

The judge wrote that “on this point there are glaring gaps,” with “even under the most generous reading, only six appear to have any meaningful expertise in vaccines.”

In response to the ruling, HHS canceled a scheduled ACIP meeting. Several of the members said they were told the committee was being disbanded, though HHS later said that was not the case.

On Monday, HHS published a notice in the Federal Register indicating that it was renewing the ACIP charter. In addition to changes in the charter, the renewal notice appears to broaden the criteria for membership.

The previous charter specifies that the committee should consist of up to 19 members “who are knowledgeable in the fields of immunization practices and public health, have expertise in the use of vaccines and other immunobiologic agents in clinical practice or preventive medicine, have expertise with clinical or laboratory vaccine research, or have expertise in assessment of vaccine efficacy and safety.”

The renewal notice specifies that members of the committee should come from a balance of specialty areas and gives examples of biostatistics, toxicology, immunology epidemiology, pediatrics, internal medicine, family medicine, nursing, consumer issues, state and local health department perspectives, academic perspectives and public health perspectives. It also says members should represent a diversity of geographic locations within the US.

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