In recent months, a seismic shift in U.S. vaccine policy has sparked a fierce response from entrenched stakeholders. Under the leadership of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., the Advisory Committee on Immunization Practices (ACIP), which advises the Centers for Disease Control and Prevention (CDC), underwent a dramatic overhaul. Kennedy dismissed all 17 ACIP members, citing conflicts of interest with pharmaceutical companies, and appointed eight new members to steer vaccine recommendations toward evidence-based science. This move has galvanised vaccine makers, pharmacists, medical societies, and state health officials, many with deep financial ties to the vaccine industry, into forming a coalition to preserve the status quo, as reported by The Washington Post. Their goal: to establish a parallel, nongovernmental vaccine recommendation and purchasing system that sidesteps federal oversight. This post examines the motivations, strategies, and implications of this unprecedented pushback against Kennedy's reforms.
Kennedy's decision to dismantle the ACIP stemmed from long-standing concerns about its independence. Investigations by The Defender (see below) revealed that most ACIP members had direct financial ties to pharmaceutical giants like Merck, Pfizer, and Sanofi, raising questions about whether their recommendations served public health or corporate profits. Kennedy argued that the committee had become a "rubber stamp" for industry, failing to scrutinise vaccines adequately, particularly for vulnerable populations like infants and pregnant women. In a Wall Street Journal op-ed, he called for a "clean sweep" to restore public trust in vaccine science.
The response was swift and polarised. Public health establishment figures, including dismissed ACIP member Dr. Helen Chu, who received thousands from Merck, decried the move as a threat to the U.S. vaccine program. Chu, in a MedPage Today op-ed, urged physicians to ignore the new ACIP's recommendations, a stance that research scientist James Lyons-Weiler warned could violate federal compliance for healthcare providers receiving federal funds. Meanwhile, Kennedy's supporters hailed the purge as a necessary step to dismantle "agency capture" by Big Pharma.
The Washington Post detailed a coalition of vaccine industry stakeholders, manufacturers, insurers, pharmacists, and medical associations, organising to bypass HHS and CDC guidance. Facilitated by the Vaccine Integrity Project, a University of Minnesota initiative backed by Walmart heiress Christy Walton's nonprofit iAlumbra, this group is exploring ways to maintain vaccine uptake despite Kennedy's reforms. Their strategies include:
1.Direct Vaccine Procurement: The coalition aims to order vaccines directly from manufacturers, circumventing federal programs like the Vaccines for Children Program, which relies on ACIP recommendations to cover costs for half of U.S. children.
2.Alternative Recommendations: They plan to prioritise vaccine schedules from medical associations like the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) over ACIP's guidance. These groups, however, have their own conflicts, AAP has received millions from Merck, Pfizer, and Sanofi, while ACOG took $11 million from the CDC to promote COVID-19 vaccines for pregnant women.
3.State-Level Workarounds: Recognising that state laws often tie school mandates and pharmacist prescribing authority to ACIP recommendations, the coalition is engaging state health officials to explore alternative legal frameworks.
The Vaccine Integrity Project, led by former FDA Commissioner Margaret Hamburg and Dr. Harvey Fineberg, claims to use "the best available evidence" to safeguard vaccine policy. However, critics like Lyons-Weiler argue it represents "overt industry self-governance," replacing government oversight with a corporate-friendly system. HHS spokesperson Andrew Nixon echoed this sentiment, calling the coalition a "self-appointed echo chamber masquerading as oversight."
The coalition's plan faces significant hurdles. Insurance companies typically only cover ACIP-recommended vaccines, and deviating from this standard could leave patients with out-of-pocket costs, potentially reducing uptake. State laws linking vaccine mandates to ACIP recommendations further complicate efforts to establish a parallel system. Moreover, competing recommendations from medical associations could confuse doctors and patients, eroding trust in the vaccination process.
Lyons-Weiler highlighted a legal risk: physicians following non-ACIP recommendations may violate federal statutes, particularly if they participate in federally funded programs. This concern is amplified by the coalition's anonymity and lack of transparency, which contrasts with Kennedy's push for open, conflict-free science.
The vaccine lobby's pushback reveals a deeper tension in U.S. healthcare: the balance between industry influence and independent regulation. Kennedy's reforms, while controversial, aim to rebuild public trust by prioritising rigorous, unbiased science. His changes to CDC guidance, such as shifting Covid-19 vaccine recommendations for pregnant women to "no guidance," reflect a cautious approach to emerging data. The upcoming ACIP meeting, set to vote on RSV vaccines and discuss mercury-containing flu shots, will test the new committee's commitment to this principle.
Conversely, the coalition's efforts to preserve the existing system raise questions about whose interests are being served. The financial ties of groups like AAP and ACOG to pharmaceutical companies undermine their credibility as impartial arbiters. Their push for a nongovernmental system suggests a reluctance to engage with Kennedy's call for transparency, potentially deepening public scepticism about vaccines.
The vaccine lobby's organising against Robert F. Kennedy Jr.'s regime marks a pivotal moment in the debate over vaccine policy. As industry stakeholders rally to protect their influence, they risk reinforcing perceptions of corporate overreach. Kennedy's reforms offer a chance to realign public health with evidence-based science, free from conflicts of interest. The outcome of this struggle will shape not only vaccine policy but also public trust in institutions tasked with protecting health.
"Vaccine makers, pharmacists, professional medical societies and others opposed to recent changes in vaccine policy are banding together to create their own system for recommending and purchasing vaccines in a move designed to bypass government health agencies' recommendations, The Washington Post reported.
Members of the new group, all of whom profit from the vaccine industry, along with some state health officials and a "new advocacy group," are strategizing ways to preserve the vaccine status quo under U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr.
The anonymous group, which hopes to create "a nongovernmental vaccine system" for vaccine recommendations and purchasing, according to the Post, is engaged in a series of discussions.
Topics include ordering vaccines directly from manufacturers and prioritizing recommendations from medical associations rather than from the Advisory Committee on Immunization Practices (ACIP), which makes vaccine recommendations to the Centers for Disease Control and Prevention (CDC).
The move comes as Kennedy dismissed all of ACIP's sitting committee members earlier this month due to concerns over conflicts of interest in the committee. He filled eight of the 17 committee seats a few days later.
Commenting on industry insiders' efforts to create a new commission, research scientist James Lyons-Weiler, Ph.D., told The Defender:
"They want to create and lend authority to a corporation-backed, corporation-friendly committee to replace the one that was just disbanded. These moves would represent replacing the facade of regulating vaccines by a government agency with overt industry self-governance and regulation."
The Post called the move by the unspecified group of actors "extraordinary," but conceded that it "faces major challenges."
For example, insurance companies typically don't cover shots that aren't recommended by ACIP. An ACIP recommendation is also the basis on which the federal Vaccines for Children Program pays for vaccines for minors whose families can't afford them. That program covers vaccine costs for about half of U.S. children.
Also, in many states, pharmacists' ability to prescribe or administer vaccines is tied to the adult and child immunization schedules recommended by ACIP. And state laws for school vaccine requirements, as well as requirements for healthcare workers, are typically tied to ACIP recommendations.
Another problem, according to the Post, is that "potential competing recommendations could sow confusion among doctors as well as patients if it becomes unclear which recommendations to follow."
Lyons-Weiler said physicians should be wary of any recommendations coming from the nongovernmental group, especially because participating in federal programs while failing to comply with ACIP regulations could violate statutes.
"The dismissed ACIP committee members can form whatever opinion group they want, but physicians follow their recommendations over the rules and regulations of the HHS at their own peril," he said.
In a recent article, Lyons-Weiler said calls to ignore recommendations from the new ACIP committee are largely circulated by the former ACIP members who were dismissed because of their ties to Big Pharma.
Former Merck consultant and dismissed ACIP member Dr. Helen Chu was quoted in a recent op-ed in MedPage Today as calling on physicians to "turn away" from ACIP's vaccine recommendations. She received thousands of dollars from Merck in the year before her ACIP appointment.
Merck is the manufacturer of multiple major childhood vaccines, including the Gardasil HPV vaccine; the MMRII for measles, mumps and rubella; a chicken pox vaccine and several others.
"Undermining ACIP in favor of non-statutory organizations may represent a breach of federal compliance by physicians and healthcare institutions receiving federal funds," Lyons-Weiler wrote. Chu should be well aware of that fact, he added.
Initiative pushes Pharma-linked medical associations to make recommendations
According to the Post, the group's discussions are being facilitated by the "Vaccine Integrity Project," a new initiative at the University of Minnesota, which includes "vaccine manufacturers, health insurers and medical associations." The group is funded by iAlumbra, a nonprofit founded by Walmart heiress and billionaire philanthropist Christy Walton, known for her anti-Trump advocacy.
Former U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg and Dr. Harvey Fineberg, former president of the Institute of Medicine and current president of the Gordon and Betty Moore Foundation, co-chair an eight-member steering committee leading the initiative.
In an op-ed published in STAT News, Hamburg and Fineberg said the project will use "the best available evidence" to "safeguard vaccine policy, information and utilization."
When the group was launched, Michael Osterholm, Ph.D., a member of the COVID-19 Advisory Board under the Biden administration, said it was not intended to serve as a shadow or parallel version of the ACIP.
However, according to today's report from the Post, that intention appears to have changed.
Dr. Anne Zink, member of the Vaccine Integrity Project, told the Post that having each state set its own recommendations is "not ideal" and that instead, the major medical associations should make recommendations.
Medical associations participating in the Vaccine Integrity Project talks include the American Academy of Pediatrics (AAP), the American Academy of Family Physicians, the American College of Physicians, the American Pharmacists Association, and the National Foundation for Infectious Diseases, the Post reported.
In her op-ed, Chu also named the American College of Obstetricians and Gynecologists (ACOG) as a key group advising alternative vaccination policy.
Lyons-Weiler noted that AAP has received millions of dollars in grants from Merck, Sanofi and Pfizer, and that ACOG has endorsed products from its sponsors without conducting any independent review.
ACOG also took $11 million from the CDC to push the COVID-19 vaccines on pregnant women.
HHS spokesperson Andrew Nixon said the agency and CDC "remain committed to ensuring that vaccine guidance is rigorous, independent, and truly in service to the health of the American people — not corporate interests."
The Post reported that Nixon also called one of the new coalition's leading organizations "a self-appointed echo chamber masquerading as oversight."
Under Kennedy, the CDC has changed its guidance on COVID-19 vaccines for pregnant women from recommended to "no guidance."
One member of the Vaccine Integrity Project, Asa Hutchinson, former Republican governor of Arkansas, noted that beyond changes to COVID-19 vaccine recommendations, no other changes have been made to vaccine policy since Kennedy took office.
In the upcoming meeting this week, ACIP is set to vote on RSV (respiratory syncytial virus) immunization recommendations for pregnant mothers, babies and young children.
The committee will also vote on the mercury-containing flu vaccine, and will discuss but not vote on other vaccines, including COVID-19, chikungunya, anthrax and MMRV (measles, mumps, rubella, varicella).