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The restructuring of the Advisory Committee for Immunization Practices (ACIP) could impact recommendations for routine childhood and adult vaccinations.
The US Department of Health and Human Services (HHS) has announced a reconstitution of the Advisory Committee for Immunization Practices (ACIP), removing the 17 sitting members of the committee with the intention to replace them with new members appointed by the Trump administration. The change was announced through a news release from HHS and an opinion piece in the Wall Street Journal by HHS Secretary Robert F. Kennedy, Jr.1,2
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Citing the goal of restoring public trust in vaccines, Secretary Kennedy said that a new slate of ACIP members would “reestablish public confidence in vaccine science.” In his opinion piece, Kennedy claimed that “a history of conflicts of interest, persecution of dissidents, a lack of curiosity, and skewed science” has burdened the regulatory process for vaccines, alleging that ACIP “has become little more than a rubber stamp for any vaccine.” ACIP is still set to convene its next meeting—with new committee members—from June 25 to June 27 at CDC Headquarters.1,2
ACIP was created under section 222 of the Public Health Service Act. The body advises the CDC through recommendations on how to use vaccines in the United States, with the CDC utilizing their recommendations to devise the US adult and childhood immunization schedules. Members are appointed by the HHS Secretary following an application and nomination process and comprise numerous areas of expertise, including vaccinology, immunology, internal medicine, and others.3
Guidelines are in place to prevent conflicts of interest within ACIP. According to the body, ACIP does not appoint individuals who are directly employed by or who have an immediate family member directly employed by a vaccine manufacturer; who hold a patent on a vaccine or related product; or who serve on a board of directors of a vaccine manufacturer. Investigators of vaccine studies are not excluded from membership, but they are mandated to abstain from voting on recommendations related to the vaccine they are studying and cannot vote on any other vaccines manufactured by the company funding their research or those like their studied vaccine.4
Additionally, members of ACIP must declare potential or perceived conflicts of interest that arise during their tenure, along with any relevant positions of authority, poignant business interests, or other connections relevant to the work of ACIP. The chair of ACIP calls for conflict of interest disclosures from each voting member at every ACIP meeting, and those with declared interests must recuse themselves from participating in deliberations and votes. ACIP lists online the previous disclosures of conflicts of interest from ACIP members across the last 25 years. It is unclear if new transparency initiatives will be implemented at ACIP following the reconstitution of the committee.4,5
Secretary Kennedy has previously expressed distrust towards the vaccine regulatory process, specifically ACIP. In his Wall Street Journal piece, Kennedy explained his belief that ACIP members regularly flout conflict of interest guidelines and that enforcement was “weak to nonexistent” and cited a 2009 HHS inspector general report to back up his claim. The report, titled “CDC’s Ethics Program for Special Government Employees on Federal Advisory Committees,” found that 97% of special government employees across all 17 CDC advisory committees—not just ACIP—did not properly complete financial disclosure reports.6
However, the review did not find serious conflicts, and the CDC said that they planned to implement improvements coinciding with the review’s recommendation. Pharmacy Times requested comment from HHS on specific instances of major conflicts of interest among ACIP members. Emily G. Hilliard, press secretary of HHS, provided a report from The Federalist that details alleged “close ties to Big Pharma” among the former ACIP members.6-8
Among the cited conflicts of interest by The Federalist are some members supporting diversity, equity, and inclusion initiatives; advocating for public health measures such as face masks and vaccine requirements during the COVID-19 pandemic; and donating to politicians from the Democratic party. The report also details alleged conflicts of interest that have already been disclosed and made publicly available. For example, the article states that Yvonne Maldonado, MD, a pediatric infectious disease clinician, served on the Data and Safety Monitoring Board for Pfizer meningococcal vaccine trials and was the Stanford principal investigator for Pfizer respiratory syncytial virus (RSV) and COVID-19 vaccine trials. These conflicts are listed in ACIP’s conflict of interest database, and Maldonado abstained from voting on COVID-19 vaccine recommendations and did not vote on RSV vaccine guidance.8,9
Jeff Goad, PharmD, MPH, professor of pharmacy practice at Chapman University School of Pharmacy, highlighted the importance of a transparent and fact-based ACIP for pharmacists and their patients. Pharmacists and health care providers are in a critical position to counsel patients on ACIP-recommended vaccines and oftentimes require an ACIP recommendation to receive insurance coverage for a vaccine. Goad explained that providers must be prepared to assist patients with their vaccine access concerns.10
“Maintaining clear, transparent, and science-based communication is vital,” Goad said in an interview. “Decisions regarding vaccine recommendations should involve broad stakeholder input, including expert advisory committees, such as… the CDC's Advisory Committee on Immunization Practices (ACIP), to maintain public confidence and ensure a rigorous scientific process has been applied to any vaccine recommendation.”10
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