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Kennedy Is Driving a Vast Inquiry Into Vaccines, Despite His Public Silence
Health Secretary Robert F. Kennedy Jr. has said little publicly about vaccines in recent months, at the behest of a White House worried that his unpopular stance will hurt Republicans in November’s midterm elections. But he has not abandoned his quest for evidence that they are unsafe.
Working behind the scenes, Mr. Kennedy is spearheading an intense push, across health agencies under his purview, for government scientists and federal data contractors to examine his long-held theory that vaccines are helping to fuel an epidemic of chronic disease, according to multiple people familiar with the effort.
They said the wide-ranging inquiry is a top priority for Mr. Kennedy, who sees vaccines as a “potential culprit” in various neurological and autoimmune disorders, including asthma and allergies. It resurrects research into a number of ideas Mr. Kennedy has espoused, including whether vaccines are linked to autism and whether thimerosal, a preservative that has largely been removed from vaccines in the United States but remains in some flu shots, is dangerous.
The effort is being led by Martin Kulldorff, a biostatistician and vaccine safety expert who rose in prominence during the pandemic as a critic of Covid restrictions and vaccine mandates, and is now the health department’s chief science and data officer.
Career scientists at the Food and Drug Administration and the Centers for Disease Control and Prevention are conducting the research alongside contractors who provide statistical expertise and access to millions of patient medical records. The initiative was described to The New York Times by six people who are close to it, all of whom insisted on anonymity because it is not public.
The work is raising alarms among some vaccine scholars and critics of Mr. Kennedy, who have long accused the secretary of cherry-picking data and misinterpreting studies to claim that vaccines are unsafe and to limit their use. They fear Mr. Kennedy will use the findings to further erode confidence in vaccines, which the World Health Organization estimates saved 154 million lives over the past half-century.
Mr. Kennedy, who came into office saying he would do nothing to discourage people from getting vaccinated, has already taken steps to scale back the number of vaccines children receive. Public health experts complain that by spending money on issues that have already been thoroughly studied, he is taking funds away from research that might answer the very questions he is asking, including what causes autism.
“It just demonstrates that no matter what the general tone is about vaccines, whether we talk about them or not, the secretary is going to continue to try and look at the data and analyze it in a way that will help support the conclusions that he’s already made,” said Dr. Daniel Jernigan, who oversaw vaccine safety at the C.D.C. until he resigned in August. “And that, to me, is a real problem.”
Andrew Nixon, a spokesman for Mr. Kennedy, said in a statement that the effort reflected President Trump’s dedication to advancing “gold-standard vaccine research” that will enable policymakers to “better understand vaccine safety and efficacy and to assess how vaccine exposure, timing and patterns affect health across the life span.”
Mr. Nixon said the work would “inform vaccine recommendations, address critical gaps identified by scientific and medical organizations, including the Institute of Medicine, and strengthen public trust in public health.”
He said the initiative also involved the National Institutes of Health and universities. It remains unclear what the effort will cost and whether it is supplanting other routine government vaccine surveillance.
A former plaintiff’s lawyer, Mr. Kennedy has long said that he wants to build a body of scientific evidence on the harms of vaccines and environmental exposures, which he believes are behind an epidemic of chronic disease. That evidence, he has said, will lay the groundwork for legal action.
“That’s how you really change policy,” Mr. Kennedy said in a podcast as a presidential candidate in 2024. He added, “I’m going to provide that enough science, sufficient science, on each one of these exposures and each one of these injuries, to show who’s causing what and hold them responsible in court.”
During a daylong meeting on the new vaccine research initiative in late February, officials from the Health Department and the C.D.C. gathered to discuss specific studies and methods, including a look at the overall effect of the childhood vaccine schedule. Representatives from major health systems such as Kaiser Permanente were also at the table, given their role in allowing the C.D.C. access to vast troves of data through its Vaccine Safety Datalink system.
As part of the new effort, Mr. Kennedy has tasked some government scientists with studying the health status of vaccinated children compared with those who were not vaccinated. Mr. Kennedy coauthored a book, “Vax-Unvax: Let the Science Speak,” calling for such studies, which he believes will prove harm from vaccines.
Researchers say that such comparison studies would be riddled with pitfalls. Vaccinated children are more likely to receive medical care than those who are unvaccinated, and are thus more likely to receive additional medical diagnoses that could be wrongly attributed to vaccines.
Mr. Kennedy is also asking for the group to undertake new studies looking at the link between vaccines and autism.
The project is also looking at the question of harm from thimerosal, a mercury-based vaccine preservative, according to people close to the effort. The preservative has been thoroughly studied and found to be unrelated to autism, but Mr. Kennedy has remained concerned about it, and has rescinded federal recommendations for flu vaccines that contain thimerosal.
Through the C.D.C. alone, the cost of the project is estimated at $40 million to $50 million, according to a person familiar with the matter.
The project is being overseen by Mr. Kennedy and Stefanie Spear, his closest adviser. Mr. Kennedy’s new senior counselor for public health, Dr. Sara Brenner, a veteran of the F.D.A. who has voiced skepticism of vaccines, is expected to propel the studies forward in her new role, according to people familiar with the plan.
The new vaccine initiative is not the first time the secretary has waged a behind-the-scenes effort to study vaccine safety. Last year, Mr. Kennedy faced significant pushback within federal agencies and from Congress when he deployed David Geier, whose vaccine research is considered deeply flawed, to dig into vaccine safety data to explore some of the secretary’s longstanding concerns.
Mr. Kennedy’s team put pressure on C.D.C. officials, including Dr. Jernigan, who delayed Mr. Geier. When Mr. Kennedy ousted Susan Monarez, the agency’s director, Dr. Jernigan and other C.D.C. leaders quit.
Within the C.D.C. and F.D.A., scientists have registered some relief that Dr. Kulldorff, a pioneer in methods to examine vaccine safety, is leading the new inquiry. He worked on research that was groundbreaking in 2009 to monitor the safety of the H1N1 flu vaccine as it was being rolled out. The team he worked with found a slightly elevated rate of Guillain-Barré syndrome, an autoimmune condition associated with some vaccines.
“Martin had been known for decades as a top-notch vaccine safety scientist,” said Daniel Salmon, a Johns Hopkins University vaccine researcher who worked with Dr. Kulldorff on a vaccine data system that predated one the F.D.A. now uses.
Some scientists who worked with Dr. Kulldorff in the past, though, wonder if the evenhanded biostatistician they once knew changed during the pandemic. They point to a federal document, coauthored by Dr. Kulldorff, justifying sharp limitations on vaccines recommended to children in the United States, saying it left out reams of studies supporting flu and hepatitis B vaccines for infants and children.
In 2024, Dr. Kulldorff joined Mr. Kennedy in litigation against Merck, the makers of Gardasil, a vaccine for the human papilloma virus, earning $400 per hour as an expert witness, court records show. Merck, the vaccine’s maker, challenged Dr. Kulldorff’s standing as an expert based on his prior research finding that the vaccine was safe.
Dr. Kulldorff did not respond to a request for comment, and the health department did not respond to a request to make him available. Mr. Kennedy and Ms. Spear also did not respond to requests for comment.
The C.D.C. and the F.D.A. already devote considerable effort to investigating vaccine safety, using a number of databases and research methods. But Mr. Kennedy’s fellow vaccine critics, including Retsef Levi, a mathematician at the Massachusetts Institute of Technology who serves on Mr. Kennedy’s handpicked a panel of C.D.C. vaccine advisers, find fault with the current studies.
“Many of them have serious methodological flaws,” Dr. Levi said.
Mr. Kennedy began raising questions about vaccines’ safety about 20 years ago, and became a champion for mothers of children with autism who blamed the condition on vaccines. People familiar with his thinking say he still feels deeply committed to those women, and cannot reconcile their often heartbreaking stories with the vast body of research that discounts a link.
For parents who believe vaccines have harmed their children, Mr. Kennedy is fulfilling a major promise. Katie Wright, whose 24-year-old son has autism and got to know Mr. Kennedy through her advocacy for parents who question the safety of vaccines, said more research is necessary to restore trust in childhood immunization.
“There’s been tremendous pushback; they say, ‘Well, the research has been done.’ ” Ms. Wright said. “Well, you know what? A lot of families are concerned. I don’t understand the fear of delving deeper into safety research.”
As health secretary, Mr. Kennedy has demonstrated an unorthodox view of what makes for reliable findings about vaccines. He dismissed a major vaccine study of 1.2 million Danish children over 24 years as “a deceitful propaganda stunt,” for failing to highlight a subset of about 50 children who were more likely to have gotten Asperger’s syndrome, a diagnosis previously applied to high-functioning people with autism, after getting vaccines.
In the language of vaccine science, such findings are considered a signal to be examined in more depth. Dr. Kathryn Edwards, a Vanderbilt University expert in vaccinology, said she was concerned that selective attention to such signals could be “used to further erode the confidence that people have in vaccines.”
Mr. Kennedy has also made hasty changes to vaccine policy, often with minimal scientific justification for decision making. Among those pivots was an overhaul in January of vaccine recommendations, reducing the number of immunizations for American children to 10 from 17.
Though the plan was held up in court, Dr. Edwards said it portends a scenario where the findings of the current effort get a big splash in the media or drive new policies before scientists can understand the reasoning.
“What they’ve done is also worrisome,” she said, “because there have been so many things that haven’t been open and transparent.”
Musicians have been left out of settlements between major record labels and AI companies, a new lawsuit alleges.
The American Federation of Musicians of the United States and Canada (AFM), which has 70,000 members, said Universal Music Group and Warner Music Group “received significant compensation” from the AI companies for past copyright violations and licensed “substantial” portions of their music catalogs to them, but haven’t shared that with the musicians.
UMG and WMG sued AI companies Udio and Suno in 2024, accusing them of copyright infringement. Both companies settled with Udio last year. In November, WMG announced a partnership with Suno, but Universal Music Group’s lawsuit against Suno is pending.
“While the Defendants protected their own interests and created a significant source of new revenue with the retrospective settlements and prospective licenses, they have refused to compensate the musicians whose work — created with their own instruments and through their talent, creativity, and hard work — is fed into AI machines for profit,” AFM said in its lawsuit, filed in U.S. District Court in New York on Friday.
AFM said it believes the AI settlements fall under the “new use” provision of its collective bargaining agreements, which requires music companies to notify the union of new licenses for purposes not covered by the contract and to compensate musicians, whose work was used to train AI models.
UMG and WMG said in statements that they are in negotiations on a collective bargaining agreement with AFM.
“Warner Music Group is growing the value of music by establishing guardrails and architecting a healthy AI ecosystem on behalf of artists everywhere,” the company said in a statement.
Universal Music Group said it will continue to work to resolve issues during the negotiations.
“Universal Music Group has been at the forefront of protecting the rights and advancing the interests of artists and songwriters in the age of AI — striking responsible AI licensing agreements to ensure they are compensated, leading the charge for legislation to further protect them and taking legal action against bad actors,” the company said in a statement.
“We expect to continue our strong working relationship with the AFM built on mutual respect for the talented musicians in our industry.”
AI has become more popular among consumers, dramatically changing the landscape in the entertainment industry. Many startups have popped up allowing users to type text prompts into AI systems to generate original songs, video clips and stories.
Some creatives say the AI tools help them brainstorm or illustrate bold ideas on a budget. But critics have raised concerns about whether AI systems are trained on copyrighted works without permission or payment to artists. Others are worried AI could eliminate their livelihoods.
Udio said it would create a new platform that would train on licensed and authorized music with artists having the ability to opt-in. Suno agreed to change its platform, launching new licensed models, and place download restrictions.
Bradford Auerbach, a partner at law firm OGC, said he expects to see more of these types of lawsuits filed by unions.
“You’ve got the unions always protecting the status quo, so you’ve got this invariable conflict of new technology coming in, and moving the cheese for a lot of people that were accustomed to having their business set up the way it was,” Auerbach said.
WASHINGTON — President Trump signed an executive order Tuesday directing the federal government to establish a voluntary early review process for the country’s most advanced artificial intelligence models, following a months-long internal battle over how aggressively Washington should move to regulate the fast-growing technology.
Under the order, companies are asked to allow government agencies, including the National Security Agency and representatives of the Defense Department, to evaluate cutting-edge models up to 30 days before they are released to the public. The order stops short of mandating participation and explicitly bars the creation of any new licensing or permitting for AI models.
“The main question is whether this is the start of a continued government clamp down and response to continued AI capabilities, or whether this is a one-off, limited, and truly voluntary act,” said James Sanders, research associate at the Center for a New American Security, a Washington, D.C., think tank.
“It’s unclear how voluntary this will stay and how voluntary it will be in practice as the AI labs try to maintain good relationships with the U.S. government,” he said.
The order represents a reversal for Trump, less than two weeks after he scuttled a version of the policy that gave the government a 90-day review period — and, more broadly, for an administration that came to power promising to strip away AI guardrails, a posture that slowly created fractures within the GOP.
In the executive order, Trump appeared to frame a need to foster AI technologies while taking into account national security. “As these capabilities evolve, my Administration will continue to work closely with industry to ensure that the best and most secure technology is deployed rapidly to confront any and all threats to our country,” he said in the order.
The step set off immediate debate about whether Trump’s plan would be an effective approach. It formalizes an existing practice in which top AI companies share models with external evaluators and government players before deploying them publicly, but raises questions about how voluntary it will be and how the government will choose which labs to target.
David Sacks, who previously served as Trump’s AI advisor, called the 30-day window a “game changer,” arguing that the shorter timeline would allow companies to engage with the government without slowing down new model releases.
“In the AI race, every day counts,” Sacks wrote in a post on X.
Mark Carroll, director of Engineering at Amazon Web Services Annapurna Labs, places his hand on a compute sled of the new Trainium3 system at Annapurna Labs in Austin, Texas, on February 3. Tech titan Amazon is working to step out of Nvidia’s shadow with custom “Trainium” chips designed specially for machine learning as billions of dollars are poured into artificial intelligence.
(Mark Felix / AFP via Getty Images)
Dean W. Ball, Trump’s former AI advisor, characterized the order as a victory for the AI “safety contingent” and a loss for Sacks and others who promote a more accelerated approach. He called the order a mistake, saying it could be a first step toward a federal licensing requirement for AI models.
“All for a benefit that is barely articulable; what, exactly, is the intelligence community going to do in 30 days to make the models safer?” Ball wrote on X.
The signing of the executive order occurred amid growing tensions among Republicans over AI, job loss and data center construction, including fear among a significant portion of Trump’s supporters that artificial intelligence could eliminate jobs or become a security threat. Polling in May had shown strong support among Republicans for a framework like the one outlined in Trump’s executive order.
The growing split among Republicans over AI was clearly visible in Florida on Monday, where James Uthmeier, the state’s Republican attorney general, sued OpenAI over the alleged risks of ChatGPT, citing the use of the bot by a gunman in a shooting at Florida State University last year.
Meanwhile, Rep. Byron Donalds — the Trump-endorsed candidate to succeed Gov. Ron DeSantis — said Monday that he did not agree with Trump on AI policy, indicating he supported state-led regulation, a shift for a candidate who had been backed by the AI industry earlier in the year.
A poll released by Americans for Responsible Innovation, a nonprofit advocating for a federal framework for AI policy, found that the majority of Republican voters polled supported the type of plan laid out in Trump’s executive order. Seventy-one percent also said independent security testing should be required by law for advanced AI systems.
When Trump took office, his administration pivoted away from Biden-era policies requiring AI companies to test their AI models and share safety results with the government before public release, reversing the U.S. posture on regulation.
That changed after Anthropic — acting on its own initiative — brought its Claude Mythos Preview model to senior White House officials, a move that exposed vulnerabilities in its software and raised concerns about the potential need for safety-testing of AI models before broad public release.
The White House attempted to downplay the executive order as a regulatory move, emphasizing in a post Tuesday that the federal government would not conduct sweeping oversight and the process outlined in the executive order would be voluntary.
“We are NOT conducting oversight of all new models, as that level of government overreach would have chilling effects on free speech and innovation,” the White House Office of Science and Technology Policy posted on X.
Trump’s signing of the order prompted calls from those who support stricter AI regulation for Congress to take steps beyond Trump’s plan. Thus far, Congress has not passed any major legislation to regulate artificial intelligence.
“Congress should take the structure this order creates, make participation mandatory, and extend it beyond cyber threats to the full range of risks the most capable models present,” Riki Parikh, policy director of the Alliance for Secure AI, a nonprofit that promotes safeguards for AI, said on X, saying the order’s voluntary framework “isn’t enough.”
Progressives, including Gov. Gavin Newsom and Vermont Sen. Bernie Sanders, said the executive order was too weak and slammed Trump for flip-flopping on regulation.
Some experts suggested the distinction between voluntary and mandatory sharing of their cutting-edge technology may be crucial.
“No company is formally required to participate, but if a developer wants to sell frontier AI systems to the federal government, participation may soon become the price of entry,” Jessica Tillipman, a professor who studies contracting law at George Washington University, wrote in a post on X.
The administration’s approach was welcomed by industry leaders, including Microsoft President Brad Smith, who said the order was “an important step toward advancing innovation while protecting the security of the American public.”
Anthropic endorsed the order and called it “an important step in strengthening America’s leadership in AI.” The company said it was looking forward to supporting the implementation of the program.
Ceballos and McDaniel reported from Washington, Christopher from Los Angeles. Times staff writer Michael Wilner contributed to this report.
Business
Ex-girlfriend of former Google CEO Eric Schmidt ordered to pay him $10 million after rape accusations
An arbitrator has sided with former Google Chief Executive Eric Schmidt, saying in a preliminary ruling that he was not guilty of sexual assault against his former girlfriend and business partner Michelle Ritter.
The arbitrator, retired Washington State Judge Beth Andrus, recently ordered Ritter to pay $10.7 million in damages to Schmidt.
Ritter sued Schmidt in Los Angeles County Superior Court last September, accusing the billionaire tech mogul of “forcibly” raping her on a yacht off the coast of Mexico in 2021. She also alleged Schmidt forced her to have nonconsensual sex at the Burning Man festival in 2023.
“I clearly told him ‘no’ and tried to get him to stop, but I had learned that attempting to resist physically would be futile and make things worse,” Ritter said in a legal filing.
Schmidt has denied the accusations under oath. The arbitrator said that Ritter did “everything she could possibly do” to avoid discussing the rape accusations under oath.
Ritter had a romantic relationship with the 71-year-old Schmidt after they met in 2020 while she was pursuing graduate degrees in law and business at Columbia University. He invested about $100 million in a joint venture with her that later fell apart.
The pair’s dispute stretches back to 2024 after their personal relationship unraveled and as they were negotiating a settlement of their Steel Perlot venture, a business accelerator that invested in artificial intelligence, crypto and other startups.
Ritter also accused Schmidt of stealing the joint venture from her, which he denied.
“One can also conclude that Ritter engaged in self-centered efforts to obtain revenge against Schmidt in a way that was more damaging than helpful to her cause,” Andrus wrote in her decision, which was recently made public. “I find that Ritter’s statement that she was raped by Schmidt to be false.”
Ritter, 32, alleged that a 2022 federal law inspired by the #MeToo movement intended to end forced arbitration of sexual assault and harassment claims allowed her to have her case heard in open court.
Superior Court Judge Michael Small disagreed, ruling that the law did not apply because a financial settlement and arbitration agreement Ritter and Schmidt signed in December 2024 was entered into after the alleged sexual wrongdoing — not before as legally required.
The judge sent the case to arbitration in March. Ritter filed a federal lawsuit in California in April challenging the arbitration. That litigation is pending.
Schmidt served as Google chief executive from 2001 to 2011 and later as the chairman of the Silicon Valley company and its parent, Alphabet Inc., until 2017.
Schmidt is worth about $52 billion, largely through his stock holding in Google’s parent company, Alphabet, according to Bloomberg.
Last year, Schmidt took a controlling interest in Relativity Space, a Long Beach rocket startup founded in 2015.
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