Six medical organizations are suing Health Secretary Robert F. Kennedy Jr. and several other public health officials and agencies over recent changes to COVID-19 vaccine recommendations for children and pregnant women.

According to the 42-page lawsuit, filed Monday in federal court in Boston, the new recommendations are “baseless and uninformed” and place pregnant women and children at “grave and immediate risk.”

The lawsuit alleges the changes will lead to “decreased rates of vaccination, increased rates of transmission, long-lasting illness, and ultimately deaths among pregnant women, unborn children, and all children.”

The complaint also claims Kennedy violated federal law when he issued an internal directive to change the recommendations instead of following the “longstanding process” for making changes to the Centers for Disease Control and Prevention’s (CDC) immunization schedules.

Plaintiffs include the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), the American Public Health Association, the Infectious Diseases Society of America, the Massachusetts Public Health Association, the Society for Maternal-Fetal Medicine, and a physician named in the complaint as “Jane Doe,” who is 20 weeks pregnant and allegedly faces “barriers to access to the vaccine.”

The plaintiffs seek an injunction against the directive, request the restoration of the COVID-19 vaccines to the list of recommended immunizations for pregnant women and healthy children and a court order compelling Kennedy to “announce on X that those immunizations are now reinstated to the CDC immunization schedules.”

Other defendants named in the complaint include the U.S. Department of Health and Human Services (HHS), the CDC and its acting director Matthew Buzzelli, Director of the National Institutes of Health Jay Bhattacharya and Marty Makary, commissioner of the U.S. Food and Drug Administration (FDA).

Pharma has ‘tremendous financial incentive’ to ‘preserve the status quo’

Attorney Richard Hughes IV, a professorial lecturer in law at George Washington University Law School, who, according to The New York Times, is “leading the effort” to challenge the directive, said Kennedy “aims to destroy vaccines.”

But according to Kim Mack Rosenberg, general counsel for Children’s Health Defense (CHD), “The medical cartel — funded extensively by the pharmaceutical industry — has a tremendous financial incentive to preserve the status quo.”

Karl Jablonowski, Ph.D., senior research scientist for CHD, noted that the lawsuit “fails to mention that several plaintiffs, including the American Academy of Pediatrics, the American College of Physicians and the Infectious Diseases Society of America, received millions of dollars from the CDC to promote COVID-19 injections.”

“People who make a lot of money pushing COVID vaccines want to force a recommendation for more COVID vaccines,” Jablonowski said.

The AAP, for instance, lists pharma giants Merck, Sanofi and COVID-19 vaccine manufacturer Moderna among its donors. The organization also closely collaborates with corporations such as Coca-Cola.

Last month, two of the plaintiffs — the AAP and the ACP — signed on to the “Vaccine Integrity Project,” a new initiative seeking to bypass public health authorities through the creation of “a nongovernmental vaccine system” for vaccine recommendations and purchasing.

The group is funded by iAlumbra, a nonprofit founded by Walmart heiress and billionaire philanthropist Christy Walton, known for her anti-Trump advocacy.

Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, suggested that the organizations suing Kennedy may be concerned that evidence will come to light questioning the safety and efficacy of vaccines.

Orient said:

“These organizations evidently consider themselves to be the ultimate authorities on all vaccines and seem to feel threatened by the possibility that a government advisory committee might not agree with their position that all ‘approved’ or ‘recommended’ vaccines are ‘safe and effective’ — and necessary.”

Mack Rosenberg said the liability shield that vaccine manufacturers enjoy “allows them to exercise incredible hubris,” adding that “they desperately fear loss of this extraordinary protection.”

She added:

“The irony of the changes to COVID-19 jabs recommendations is that they actually empower physicians to do their jobs and provide individualized medical care to their patients. One has to ask why these entities fear that.”

Directive ‘arbitrary and capricious,’ lawsuit alleges

The complaint extensively references a May 27 video Kennedy posted on X, in which Kennedy, Bhattacharya and Makary announced the removal of the COVID-19 vaccine recommendation for pregnant women and healthy children, citing insufficient data to show that these populations benefited from the vaccine.

 

The lawsuit calls the directive “arbitrary and capricious” and questions Bhattacharya and Makary’s past opposition to various COVID-19 pandemic-related measures.

The complaint notes that Bhattacharya co-authored the Great Barrington Declaration, which advocated for herd immunity and targeted measures during the pandemic. The lawsuit characterized this as advocacy in favor of “the uncontrolled spread of an infectious disease to control an epidemic.”

Makary “previously made headlines for his comments during the pandemic, including advocating in favor of natural immunity, questioning the requirement for booster shots in younger people, and opposing vaccine mandates,” the lawsuit claims.

But according to Orient, throughout history, epidemics were controlled by natural immunity and measures such as vector control. “Locking down everybody was the unprecedented action,” she said.

The lawsuit also claims that the COVID-19 vaccines are FDA-approved and that a “wealth of data and peer-reviewed studies” demonstrate their safety and efficacy.

Pfizer’s Comirnaty vaccine and Moderna’s Spikevax vaccine are fully approved for ages 12 and older. But for children under age 12, the vaccines are administered under emergency use authorization.

Novavax’s Nuvaxovid vaccine is fully approved only for people 65 and older and those between 12 and 64 who have a health condition placing them at increased risk of COVID-19 infection.

Plaintiffs criticize new CDC vaccine advisory committee

Last month, Kennedy dismissed the 17 members of the Advisory Committee on Immunization Practices (ACIP) — the CDC’s vaccine advisory committee. He subsequently named eight new members to the committee.

During the new members’ first meeting, some members questioned CDC claims about the safety of COVID-19 shots and the virus’s threat to children. The committee also said it plans to examine the cumulative effect of the childhood vaccine schedule.

The lawsuit questions the qualifications of seven of ACIP’s new members, claiming they “do not possess the required scientific and medical expertise to serve on ACIP.”

The complaint also questions Kennedy’s claims that the 17 former members of ACIP had conflicts of interest. “None of these accusations are remotely true,” according to the complaint.

Orient disagreed. “It was the ACIP that Kennedy fired that was likely unlawful,” she said.

ACIP also voted last month to no longer recommend flu vaccines that contain thimerosal, a mercury-based preservative linked to neurodevelopmental disorders. The lawsuit cites a statement by the Infectious Diseases Society of America that said the vote was “politically motivated” and “not based on science.”

The complaint differentiates thimerosal, “which breaks down into ethylmercury” from “harmful forms of mercury like methylmercury.” But according to Brian Hooker, Ph.D., chief scientific officer for CHD, this distinction is “absolutely preposterous.”

“This was shown to be wrong in a seminal study by Burbacher et al., which showed that thimerosal exposure resulted in higher amounts of mercury metal essentially locked into the brains of macaque monkeys. The researchers could not determine the half-life of that mercury in the brain because it was longer than the study itself.”

In March, the AAP recommended annual flu shots for all children ages 6 months and older for the next cold and flu season.

Lawsuit claims ‘wealth’ of studies show COVID shots are safe — but doesn’t cite any

The complaint claims there is a “wealth” of data and studies showing the safety and efficacy of COVID-19 shots for kids and pregnant women, but doesn’t cite any studies.

Several peer-reviewed studies link COVID-19 shots with risks for pregnant women. An animal study published in the journal Molecular Therapy Nucleic Acids in March found that mRNA injections cross the placenta and enter the fetus within one hour, where they develop into spike protein and remain in the body after birth.

Another animal study, published in the journal Vaccines in March, found that COVID-19 vaccines decreased the number of primordial follicles in female rats by up to 60%, which may reduce women’s lifelong egg supply.

According to a study of 1.3 million Czech women published last month in the International Journal of Risk & Safety in Medicine, the rate of successful conception — a pregnancy leading to live birth nine months later — for women who received the COVID-19 vaccine was “substantially lower” than for unvaccinated women.

According to “The Pfizer Papers,” a set of 450,000 documents related to the licensing of the Pfizer-BioNTech COVID-19 vaccine, 72% of recorded adverse events were in women. Babies had to be delivered early, women hemorrhaged during childbirth, and nursing babies of vaccinated women experienced adverse effects.

Pregnant women also experienced side effects. Pfizer lost the records of 234 pregnant women who participated in the clinical trials for the vaccine, but for the 36 pregnant women whose records survived, over 80% lost their babies.

Last month, some of the plaintiffs signed a letter to insurers, urging them to continue covering COVID-19 shots for pregnant women despite the new recommendations.

Other recent studies have linked COVID-19 vaccines to health risks in children. According to a study published in the journal Pediatric Rheumatology in May, children and adolescents who received at least one COVID-19 vaccine had a 23% higher risk of developing autoimmune disease compared to unvaccinated children.

A preprint study published in May 2024 of 1.7 million children in England found cases of myocarditis or pericarditis only in those children who received the COVID-19 shots. No cases were identified in children who didn’t receive the vaccine.

Citing rising maternal mortality and “the sickest generation of American children in history,” Laura Bono, vice-president emerita of CHD and mother of a vaccine-injured child, said the plaintiffs should use their resources to solve these public health issues instead of on this lawsuit.

“Rather than spending money on a lawsuit to preserve the status quo, these associations should support their missions by looking for answers to address the declining health of mothers and children,” Bono said.

Related articles in The Defender

• Breaking: CDC Removes COVID Vaccine Recommendation for Healthy Kids, Healthy Pregnant Women
• CDC Vaccine Advisers Vote to Stop Recommending Flu Shots That Contain Thimerosal
• RFK Jr. Taps 8 New ACIP Members, Offit Concedes Most ‘Seem Reasonable’
• Breaking: RFK Jr. Removes All Members of CDC Vaccine Advisory Committee
• The Real Agenda Behind American Academy of Pediatrics: Weaponizing Children’s Mental Health and Vaccines for Profit

This article was corrected to indicate that Richard Hughes IV is affiliated with George Washington University.

Editor’s note: The Defender was unable to authenticate the April 3 BIO meeting minutes document or communicate directly with its source. However, our writing and editorial team spoke directly with James Lyons-Weiler and, on the basis of that conversation, judged the document likely to have originated from a reliable source.

 

Research scientist and author James Lyons-Weiler, Ph.D., first went public with the document on Tuesday, publishing it on Substack and in an article for the Brownstone Institute. He said he received it “anonymously by whistleblowers.”

In a statement provided to The Defender on Tuesday, a Biotechnology Innovation Organization (BIO) spokesperson said:

“Earlier today, a blog site posted an article based upon what it claimed is a leaked memo from BIO regarding our Vaccines Task Force. The purported memo was not produced by BIO. We have never seen or heard of this document and it certainly does not accurately represent the spirit, strategy, or mission of BIO’s work.

“We are aligned with Secretary Kennedy and the President’s mission to ‘Make America Healthy Again.’”

However, that statement contradicts the meeting minutes, which quote Dr. Scott Gottlieb, a Pfizer board member, as saying, “MAHA [Make America Healthy Again] is a cover for an anti-vaccine campaign.”

A U.S. Department of Health and Human Services (HHS) spokesperson told The Defender:

“Secretary Kennedy is not anti-vaccine — he is pro-safety, pro-transparency, and pro-accountability. His longstanding advocacy has focused on ensuring that vaccines and all medical interventions meet the highest standards of safety and are backed by gold-standard science.

“The fact that a prominent, taxpayer-funded lobbying organization like BIO would entertain language about ‘neutralizing’ a sitting Cabinet official, whose focus has been on restoring scientific rigor and prioritizing public health over special interests, is both concerning and revealing.”

According to the document circulated by Lyons-Weiler, BIO members discussed strategies to counter Kennedy’s growing “anti-vaccine rhetoric.”

These included engaging with other federal and state policymakers to sidestep Kennedy, repositioning vaccines as “national security assets,” and focusing public messaging “on science” and the “economic benefits” of vaccines.

Lyons-Weiler stands by document’s authenticity

Lyons-Weiler stood by the veracity of the document and his sources. Commenting on BIO’s statement that the group didn’t produce the document, he told The Defender:

“While it is exciting and reassuring to see BIO’s unreserved support for the MAHA initiative and the Kennedy evidence bar, we had sufficient information to determine to our satisfaction that the document was most likely real. Nevertheless, we ran it with caveats.

“In the interest of journalistic integrity, should evidence come forward that the document was in some way falsified, and was provided as some sort of ruse, we would be happy to publish that information as well, and let the public decide.”

On whether the document may have been leaked by “nefarious” actors, Lyons-Weiler said, “That is speculative, but one could only guess whether this would then perhaps represent a type of corporate espionage, with organizations which not so long ago left the trade association.”

“If so, it could be an attempt to divide BIO from the MAHA agenda at HHS,” Lyons-Weiler said. “Either way, I’m excited to see them ready to engage in objective and ethical biomedical research.”

In November 2024, Pharma giant GSK ended its membership with BIO. A GSK spokesperson told Fierce Pharma the company “opted not to renew its BIO membership for 2025 following an annual evaluation of its corporate memberships and trade association participation.”

GSK followed in the footsteps of other pharmaceutical companies, including Pfizer, UCB, WuXi AppTec and Takeda, who also recently left BIO, Fierce Pharma reported.

Vaccine makers raise investor concerns, but not vaccine safety concerns

AstraZeneca, Bayer, Bristol Myers Squibb, Eli Lilly, Gilead Sciences, Johnson & Johnson, Merck, Moderna, Novartis, Novavax, Novo Nordisk, Roche and Sanofi are among the major pharma companies listed as members of BIO.

According to the document, participants in the April meeting included Silvia Taylor, executive vice president and chief corporate affairs and advocacy officer at Novavax; Jim Wassil, executive vice president and chief operating officer of vaccine innovation company Vaxcyte; and Gottlieb, who in addition to being a Pfizer board member is also a senior fellow at the American Enterprise Institute and former commissioner of the U.S. Food and Drug Administration (FDA).

Wassil zeroed in on shareholder concerns, noting that investors are “sitting on the sidelines for the next 6-9 months” because the vaccine “pathway to approval is unpredictable and politicized.”

There was no mention in the meeting minutes of the need to improve vaccine safety. However, members purportedly discussed how to improve communication with the new administration “using their words — safety, efficiency, health resilience, transparency.”

John F. Crowley, president and CEO of BIO, also allegedly participated in the meeting.

The document allegedly shows that Crowley proposed a “creative communication campaign” targeting legislators and influencers instead of working “directly with RFK Jr.” The campaign would enlist the help of unions and conservative-leaning, pro-vaccine organizations like the American Enterprise Institute.

Crowley also allegedly suggested that BIO spend $2 million of its $4 million cash reserves on “vaccine programs.” The meeting included a discussion of BIO’s new “WhyWeVaccinate” campaign.

The document also suggests that “it is time to go to The Hill and lobby that it is time for RFK Jr to go … communicate what’s going on in business.”

It is unclear whether “The Hill” refers to Capitol Hill or to a publication by that name popular among policymaking circles.

A Novavax spokesperson contacted by The Defender declined to comment. Wassil and Gottlieb did not respond to a request for comment.

Despite claim of support, BIO has questioned some of RFK Jr.’s moves

In their statement, BIO emphasized the organization’s pro-vaccine campaign.

“We also believe strongly in the vital role that vaccines play for public health, and we will continue to be strong advocates for scientific rigor and the importance of vaccines to protect our children, our citizens broadly — and to protect and strengthen America. The BIO vaccines campaign supports this effort,” BIO said.

In spite of its stated support for Kennedy and the MAHA agenda, BIO has previously questioned some of Kennedy’s moves as health secretary.

In March, following the resignation of Peter Marks, M.D., Ph.D., former FDA director responsible for authorizing vaccines, under pressure from Kennedy, BIO said it was “deeply concerned” Marks’ resignation would “broadly impact the development of new, transformative therapies to fight diseases for the American people.”

Last month, following Kennedy’s dismissal of all 17 members of the Centers for Disease Control and Prevention’s vaccine advisory committee, BIO said it was “greatly concerned about the uncertainty created by the abrupt dismissal of the serving committee members.”

BIO allegedly contributed to the censorship of non-establishment views concerning COVID-19 during the pandemic.

According to “Twitter Files” documents published in January 2023 by journalist Lee Fang, BIO “fully funded a special content moderation campaign designed by a contractor called Public Good Projects” during the pandemic. The campaign worked with Twitter “to set content moderation rules around COVID ‘misinformation.’”

According to Open Secrets, 63 of BIO’s 100 lobbyists in 2024 previously held government jobs, while BIO has spent $890,000 on lobbying efforts so far this year.

Health and medical freedom advocates have said that a “revolving door” between federal public health agencies and Big Pharma has compromised the ability of those agencies to effectively regulate the industry.

In its statement, HHS said that Kennedy and HHS are working to restore trust in public health and vaccines.

“Under Secretary Kennedy’s leadership, HHS is exposing decades of waste, fraud, and abuse, eliminating conflicts of interest, and restoring evidence-based policy to medicine and public health. The Department will stay focused on our mission, which is to protect the health and well-being of the American people,” HHS said.

Related articles in The Defender

• Big Pharma Lobbied Social Media to Flag COVID ‘Misinformation,’ Latest ‘Twitter Files’ Reveal
• HHS Ousts Peter Marks, Sending Vaccine Stocks Tumbling and Biopharma Lamenting Loss of ‘Ally’ at FDA
• Big Pharma Money ‘Permeates’ World’s Drug Regulatory Agencies, BMJ Investigation Shows
• Big Pharma’s Big Spending on Lobbying Netted Big Contracts in 2020
• ‘Key to Revolving Door’: FDA Tells Staff Who Leave for Pharma Jobs They Can Work ‘Behind the Scenes’ to Influence Agency