robert f kennedy jr

large-study-squashes-anti-vaccine-talking-points-about-aluminum

Large study squashes anti-vaccine talking points about aluminum

A sweeping analysis of health data from more than 1.2 million children in Denmark born over a 24-year period found no link between the small amounts of aluminum in vaccines and a wide range of health conditions—including asthma, allergies, eczema, autism, and attention deficit-hyperactivity disorder (ADHD).

The finding, published in the Annals of Internal Medicine, firmly squashes a persistent anti-vaccine talking point that can give vaccine-hesitant parents pause.

Small amounts of aluminum salts have been added to vaccines for decades as adjuvants, that is, components of the vaccine that help drum up protective immune responses against a target germ. Aluminum adjuvants can be found in a variety of vaccines, including those against diphtheria, tetanus, and pertussis, Haemophilus influenzae type b (Hib), and hepatitis A and B.

Despite decades of use worldwide and no clear link to harms, concern about aluminum and cumulative exposures continually resurfaces—largely thanks to anti-vaccine advocates who fearmonger about the element. A leader of such voices is Robert F. Kennedy Jr, the current US health secretary and an ardent anti-vaccine advocate.

In a June 2024 interview with podcaster Joe Rogan, Kennedy falsely claimed that aluminum is “extremely neurotoxic” and “give[s] you allergies.” The podcast has racked up nearly 2 million views on YouTube. Likewise, Children’s Health Defense, the rabid anti-vaccine organization Kennedy created in 2018, has also made wild claims about the safety of aluminum adjuvants. That includes linking it to autism, despite that many high-quality scientific studies have found no link between any vaccines and autism.

While anti-vaccine advocates like Kennedy routinely dismiss and attack the plethora of studies that do not support their dangerous claims, the new study should reassure any hesitant parents.

Clear data, unclear future

For the study, lead author Niklas Worm Andersson, of the Statens Serum Institut in Copenhagen, and colleagues tapped into Denmark’s national registry to analyze medical records of over 1.2 million children born in the country between 1997 and 2018. During that time, new vaccines were introduced and recommendations shifted, creating variation in how many aluminum-containing vaccines children received.

Large study squashes anti-vaccine talking points about aluminum Read More »

rfk-jr.-may-be-about-to-demolish-preventive-health-panel,-health-groups-fear

RFK Jr. may be about to demolish preventive health panel, health groups fear

“Worrying”

With the latest cancellation, experts fear the USPSTF is next. “This is very worrying, because if past is prologue, it may suggest that they are preparing to eliminate or emasculate the committee,” Peter Lurie, executive director of the Center for Science in the Public Interest, told The New York Times.

Such concerns were first raised after a June 27 US Supreme Court ruling that upheld the provision in the Affordable Care Act that requires health plans to cover USPSTF A- and B-grade recommendations. The ruling preserved critical preventive care coverage but affirmed Kennedy’s authority to control the task force—such as replacing members and undoing recommendations.

In a letter to Congress this week, health and medical organizations urged lawmakers to protect the USPSTF from Kennedy, noting the Supreme Court ruling. In the wake of the ruling, they wrote, “It is critical that Congress protects the integrity of the USPSTF from intentional or unintentional political interference. The loss of trustworthiness in the rigorous and nonpartisan work of the Task Force would devastate patients, hospital systems, and payers as misinformation creates barriers to accessing lifesaving and cost effective care.”

The letter was led by nonprofit health professional organization AcademyHealth and signed by over 100 other organizations, including the American Medical Association, the American Academy of Pediatrics, and the American Public Health Association.

RFK Jr. may be about to demolish preventive health panel, health groups fear Read More »

rfk-jr.-barred-registered-democrats-from-being-vaccine-advisors,-lawsuit-says

RFK Jr. barred registered Democrats from being vaccine advisors, lawsuit says

The lawsuit was filed by the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), the Infectious Diseases Society of America (IDSA), the Massachusetts Public Health Alliance, the Society for Maternal-Fetal Medicine, and a Jane Doe, who is a pregnant physician.

The group’s lawsuit aims to overturn Kennedy’s unilateral decision to drop the CDC’s recommendations that healthy children and pregnant people get COVID-19 vaccines. The medical groups argue that Kennedy’s decision—announced in a video on social media on May 27—violates the Administrative Procedure Act for being arbitrary and capricious.

Specifically, Kennedy made the decision unilaterally, without consulting the CDC or anyone on ACIP, entirely bypassing the decadeslong evidence-based process ACIP uses for developing vaccine recommendations that set standards and legal requirements around the country. Further, the changes are not supported by scientific evidence; in fact, the data is quite clear that pregnancy puts people at high risk of severe COVID-19, and vaccination protects against dire outcomes for pregnant people and newborns. Kennedy has not explained what prompted the decision and has not pointed to any new information or recommendations to support the move.

“Existential threat”

The medical groups say the decision has caused harms. Pregnant patients are being denied COVID-19 vaccines. Patients are confused about the changes, requiring clinicians to spend more time explaining the prior evidence-based recommendation. The conflict between Kennedy’s decision and the scientific evidence is damaging trust between some patients and doctors. It’s also making it difficult for doctors to stock and administer the vaccines and creating uncertainty among patients about how much they may have to pay for them.

In making the claims, the medical groups offer a sweeping review of all of the damaging decisions Kennedy has made since taking office—from canceling a flu shot awareness campaign, spreading misinformation about measles vaccines amid a record-breaking outbreak, and clawing back $11 billion in critical public health funds to wreaking havoc on ACIP.

The lead lawyer representing the groups, Richard Hughes IV, a partner at Epstein Becker Green, did not immediately respond to Ars’ request for comment.

But in a statement Monday, Hughes said that “this administration is an existential threat to vaccination in America, and those in charge are only just getting started. If left unchecked, Secretary Kennedy will accomplish his goal of ridding the United States of vaccines, which would unleash a wave of preventable harm on our nation’s children.”

RFK Jr. barred registered Democrats from being vaccine advisors, lawsuit says Read More »

moderna-says-mrna-flu-vaccine-sailed-through-trial,-beating-standard-shot

Moderna says mRNA flu vaccine sailed through trial, beating standard shot

An mRNA-based seasonal flu vaccine from Moderna was 27 percent more effective at preventing influenza infections than a standard flu shot, the company announced this week.

Moderna noted that the new shot, dubbed mRNA-1010, hit the highest efficacy target that it set for the trial, which included nearly 41,000 people aged 50 and above. Participants were randomly assigned to receive either mRNA-1010 or a standard shot and were then followed for about six months during a flu season.

Compared to the standard shot, the mRNA vaccine had an overall vaccine efficacy that was 26.6 percent higher, and 27.4 percent higher in participants who were aged 65 years or older. Previous trial data showed that mRNA-1010 generated higher immune responses in participants than both regular standard flu shots and high-dose flu shots.

The company noted that the positive results for the new trial come in the wake of one of the worst flu seasons in years. During the 2024–2025 flu season, the Centers for Disease Control and Prevention estimates that 770,000 people in the US were hospitalized for the flu.

“Today’s strong Phase 3 efficacy results are a significant milestone in our effort to reduce the burden of influenza in older adults,” Moderna CEO Stéphane Bancel said in a statement. “The severity of this past flu season underscores the need for more effective vaccines. An mRNA-based flu vaccine has the potential advantage to more precisely match circulating strains, support rapid response in a future influenza pandemic, and pave the way for COVID-19 combination vaccines.”

Moderna says mRNA flu vaccine sailed through trial, beating standard shot Read More »

after-rfk-jr.-overhauls-cdc-panel,-measles-and-flu-vaccines-are-up-for-debate

After RFK Jr. overhauls CDC panel, measles and flu vaccines are up for debate

With ardent anti-vaccine activist Robert F. Kennedy Jr. in the country’s top health position, use of a long-approved vaccine against measles, mumps, rubella, and varicella/chickenpox (MMRV) as well as flu shots that include the preservative thimerosal will now be reevaluated, putting their future availability and use in question. The development seemingly continues to vindicate health experts’ worst fears that, as health secretary, Kennedy would attack and dismantle the federal government’s scientifically rigorous, evidence-based vaccine recommendations.

Discussions of the two types of vaccines now appear on the agenda of a meeting for the Centers for Disease Control and Prevention’s Advisory Committee for Immunization Practices (ACIP) scheduled for two days next week (June 25 and 26).

ACIP’s overhaul

On June 9, Kennedy summarily fired all 17 members of ACIP, who were rigorously vetted—esteemed scientists and clinicians in the fields of immunology, epidemiology, pediatrics, obstetrics, internal and family medicine, geriatrics, infectious diseases, and public health. Two days later, Kennedy installed eight new members, many with dubious qualifications and several known to hold anti-vaccine views.

Before ACIP was upended by Kennedy, the committee planned to meet for three days, from June 25 to 27, to discuss a wide array of vaccines, including those against anthrax, chikungunya, COVID-19, cytomegalovirus (CMV), Human papillomavirus (HPV), influenza, Lyme disease, meningococcal disease, pneumococcal disease, and respiratory syncytial virus (RSV). The committee was going to vote on recommendations for the use of COVID-19 vaccines, the HPV vaccine, influenza vaccines, the meningococcal vaccine, RSV vaccines for adults, and the RSV vaccine for maternal and pediatric populations.

In the new agenda, discussion on vaccines against CMV, HPV, Lyme disease, meningococcal disease, and pneumococcal disease has been dropped. So have votes for COVID-19 vaccines, HPV, meningococcal vaccines, and RSV vaccines for adults. Instead, the new ACIP will now discuss MMRV and influenza vaccines containing thimerosal. It will only vote on two matters: RSV vaccines for children and pregnant people, and influenza vaccines, including thimerosal-containing flu vaccines.

After RFK Jr. overhauls CDC panel, measles and flu vaccines are up for debate Read More »

all-17-fired-vaccine-advisors-unite-to-blast-rfk-jr.’s-“destabilizing-decisions”

All 17 fired vaccine advisors unite to blast RFK Jr.’s “destabilizing decisions”

The members highlighted their medical and scientific expertise, lengthy vetting, transparent processes, and evidence-based approach to helping set federal immunization programs, which affect insurance coverage. They also lamented the institutional knowledge lost by the removal of the entire committee and its executive secretary, as well as cuts to the CDC broadly. Together they “have left the US vaccine program critically weakened,” the experts write.

“In this age of government efficiency, the US public needs to know that the routine vaccination of approximately 117 million children from 1994–2023 likely prevented around 508 million lifetime cases of illness, 32 million hospitalizations, and 1,129,000 deaths, at a net savings of $540 billion in direct costs and $2.7 trillion in societal costs,” they write.

They also took direct aim at Kennedy, who unilaterally changed the COVID-19 vaccination policy, announcing the changes on social media. This “bypassed the standard, transparent, and evidence-based review process,” they write. “Such actions reflect a troubling disregard for the scientific integrity that has historically guided US immunization strategy.”

Since Kennedy has taken over the US health department, many other vaccine experts have been pushed out or left voluntarily. Peter Marks, the former top vaccine regulator at the Food and Drug Administration, was reportedly given the choice to resign or be fired. In his resignation letter, he wrote: “it has become clear that truth and transparency are not desired by the Secretary [Kennedy], but rather he wishes subservient confirmation of his misinformation and lies.”

All 17 fired vaccine advisors unite to blast RFK Jr.’s “destabilizing decisions” Read More »

after-rfk-jr.-fires-vaccine-advisors,-doctors-brace-for-blitz-on-childhood-shots

After RFK Jr. fires vaccine advisors, doctors brace for blitz on childhood shots


The medical community is outraged, but Sen. Bill Cassidy continues to be reassured.

US Secretary of Health and Human Services nominee Robert F. Kennedy Jr. listens as President Donald Trump holds a cabinet meeting at the White House in Washington, DC, on February 26, 2025. Credit: Getty | Jim Watson

The medical community is bracing for attacks on, and the possible dismantling of, federal recommendations for safe, lifesaving childhood vaccinations after health secretary and fervent anti-vaccine advocate Robert F. Kennedy Jr. abruptly fired all 17 members of a federal vaccine advisory committee Monday.

Outrage has been swift after Kennedy announced the “clean sweep” of the Centers for Disease Control and Prevention’s vaccine advisory panel, the Advisory Committee on Immunization Practices (ACIP). He made the announcement in a Wall Street Journal op-ed.

Open protest erupted at the CDC on Tuesday, with staff calling for Kennedy’s resignation. Staff rallied outside CDC headquarters in Atlanta, objecting to agency firings, cuts to funding and critical programs, scientific censorship, as well as ACIP’s ouster.

“I am here today to tell you that the secretary of health and human services, Robert F. Kennedy Jr., has shown himself to be a domestic health threat,” Anna Yousaf, an infectious disease researcher at the CDC’s National Center for Immunization and Respiratory Diseases, said amid the rally, according to CBS News.

“These attacks against scientific standards and well-established processes culminated yesterday when Secretary Kennedy announced that he is firing all of the members … of ACIP,” Yousaf continued, eliciting ‘boos’ from the crowd.

“The wrong side of history”

Meanwhile, the American Medical Association, which is currently holding its annual meeting in Chicago, passed an emergency resolution Tuesday calling for Kennedy to immediately reverse the ACIP purge and for the Senate to investigate Kennedy’s decision, according to reporting by MedPage Today.

Some AMA delegates expressed concern that the call for a congressional investigation was a “poison pill” that would diminish the impact of the rest of the statement and would fail to reveal any new information. But the concerns were easily quashed.

“We do not want to be on the wrong side of history,” said Jason Goldman, who introduced the emergency resolution and who is also president of the American College of Physicians. “The country is burning down. Our infrastructure is burning down. Whether the outcome of this investigation is preordained should not determine our ability and desire to… take a stand, fight for what we believe in, and ask the government to do their job.”

Priya Desai, a delegate who spoke on behalf of the medical student section, meanwhile, admonished the AMA for not taking a stand against Kennedy sooner. “We did not speak up back in November with the nomination of RFK [Jr.]… We did not speak up back in January… when he was officially endorsed. Congratulations, this poison pill we have swallowed. It is time for us to act now,” she said.

While calling to support and maintain the current ACIP structure and processes, the AMA’s emergency resolution also indicated that the association will try to establish an ACIP alternative if the CDC’s advisory committee becomes corrupted by Kennedy. The AMA will “identify and evaluate alternative evidence-based vaccine advisory structures and invest resources in such initiatives, as necessary,” the resolution reads.

“I’m very worried”

In an exclusive interview with Stat, one fired ACIP member, Helen Chu, a professor of infectious diseases at the University of Washington, said she and the rest of the board were blindsided by Kennedy’s firings. Other fired members told Stat that they could not do interviews with media after their institutions told them to keep a low profile to avoid reprisal from the Trump administration.

Chu told Stat that she did not know what ACIP’s future would look like—whether the committee would have decision-making authority, whether its discussions would remain transparent, or whether its members would continue to be experts. “But it is likely that it will send vaccine recommendations in a completely different direction than where they’ve been for the past 60 years,” Chu said.

She noted that some states have already started creating their own vaccine recommendations, which will “create an even more divided country.”

“I’m very worried,” she added. “ACIP is the model for the rest of the world in terms of how you carefully deliberate and are thoughtful and look at all of the data. … To disband what is often considered an international gold standard for vaccine policy, and to disband it in this way is just sending a very clear message to the rest of the world. And also sending a clear message to Americans that scientific expertise is no longer of use for making vaccine policy.”

Her interview also highlighted the extensive conflicts-of-interest vetting that ACIP members undergo. She was a relatively new member of the committee, only voting in one meeting prior to her termination. She had been vetted in a two-year process before that.

A big “nothing”

In Kennedy’s op-ed, he claimed that ACIP members are “plagued with persistent conflicts of interest.” But independent investigations have found that to be false. An investigation by Science found strict requirements for public disclosures, divestment of financial interests related to vaccines, and for members to recuse themselves from votes where a conflict exists.

Likewise, the editorial board of The Wall Street Journal, which opposes Kennedy’s role as health secretary, also found no evidence to support Kennedy’s attack on the now-ousted ACIP members. In a derisive response to Kennedy’s op-ed, the board wrote Tuesday that documents on ACIP members’ conflicts of interest “show that the members have properly recused themselves from decisions that involve products for which they served as trial investigators, as well as those of their competitors, or if they held stock in companies. In other words, the conflicts of interest were honestly handled.” The board concluded Kennedy’s claims “proved to be nothing.”

Since Kennedy’s ACIP purge, significant attention has shifted to Senator Bill Cassidy (R-La.), who sharply criticized Kennedy’s anti-vaccine stances but voted to confirm him anyway, saying Kennedy made public promises not to muddle vaccination policy. Those promises included not changing the ACIP.

Cassidy told a HuffPost reporter Tuesday that Kennedy did not break that promise by clearing out the ACIP. Rather, Kennedy promised he wouldn’t change “the process,” not that he wouldn’t change the committee members. In a social media post on Monday, Cassidy indicated that he continues to get reassurances from Kennedy about the promises. “Of course, now the fear is that the ACIP will be filled up with people who know nothing about vaccines except suspicion. I’ve just spoken with Secretary Kennedy, and I’ll continue to talk with him to ensure this is not the case.”

“Vindicating his critics”

The Wall Street Journal’s editorial board responded directly to Cassidy on this, writing: “That’s nice, but Mr. Kennedy seems more intent on vindicating his critics than pleasing the Senator.”

In a social media post late Tuesday, Kennedy only provided more fuel to concerns over his meddling in federal vaccine policy. The post was prefaced by saying that he would not appoint “ideological anti-vaxxers” to replace ACIP members. But, he then went on a lengthy tirade accusing ACIP of “malevolent malpractice” and attacking the evidence vaccine experts have used to assess the safety of routine childhood immunizations. Specifically, he squabbled over whether placebo-controlled trials used inert placebos or active controls.

Kennedy, who has no medical or scientific background and rejects germ theory, concluded by tying vaccines to a period in which “chronic diseases in our children exploded.” The post, like Kennedy’s lengthy history as an anti-vaccine advocate and conspiracy theorist, suggests he will continue to sow distrust about safe, lifesaving, and thoroughly vetted vaccines, if not directly work to undermine Americans’ access to them.

Kennedy says he will announce new ACIP members “in the coming days”—ditching the lengthy vetting process previously in place. The health department put out a news release suggesting that a previously scheduled meeting June 25–27 will still be held.

Photo of Beth Mole

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

After RFK Jr. fires vaccine advisors, doctors brace for blitz on childhood shots Read More »

anti-vaccine-quack-hired-by-rfk-jr.-has-started-work-at-the-health-department

Anti-vaccine quack hired by RFK Jr. has started work at the health department

Outside researchers can request access to VSD data by submitting study proposals to the CDC. The Geiers have, in the past, gained access. But, they lost that access at least twice, the Journal reported. In 2004, the CDC kicked the Geiers out after officials determined that they had misrepresented their plans for the data when they initially submitted their proposal to the CDC. They were barred again in 2006.

Now an HHS employee, Geier is seeking access to the data once again. The Journal reports that Kennedy has assigned researchers at the National Institutes of Health to assist Geier and that those NIH employees have sent a request to the CDC to hand over all of VSD’s data. This request reportedly caused alarm at the CDC and the project’s health care sites around the country, which are concerned about protecting the security of private patient data.

It’s unclear whether Geier has regained access to the data. But people familiar with the matter told the Journal that Geier aims to reanalyze the CDC’s data on thimerosal to try to prove a link to autism. The sources also said that Geier is interested in proving that the CDC is corrupt.

In the May hearing, Kennedy, who also supports the debunked claim that vaccines cause autism, defended Geier. Kennedy said that “there has been a lot of monkey business with the VSD” and that Geier is “the only living independent scientist” who has seen the data and can determine if it has been altered. (Hassan interjected that Geier is not a scientist.) Kennedy also falsely claimed that a court overturned the medical board’s finding that he had practiced medicine without a license and awarded Geier $5 million.

That did not happen. But Kennedy may have been referring to the fact that Mark Geier filed a lawsuit against the medical board over a 2012 cease-and-desist order that alleged he improperly prescribed medication for himself, his wife, and his son while his medical license was suspended. Mark Geier sued the board, saying the order was malicious because it contained personal information, including the medications Geier had prescribed. A Circuit Court sided with the Geiers, awarding them nearly $5 million in total. But the win and the award were overturned on appeal in 2019.

Anti-vaccine quack hired by RFK Jr. has started work at the health department Read More »

top-cdc-covid-vaccine-expert-resigns-after-rfk-jr.-unilaterally-restricts-access

Top CDC COVID vaccine expert resigns after RFK Jr. unilaterally restricts access

A top expert at the Centers for Disease Control and Prevention who was overseeing the process to update COVID-19 vaccine recommendations resigned on Tuesday.

The resignation, first reported by The Associated Press and confirmed by CBS News, comes just a week after health secretary and anti-vaccine advocate Robert F. Kennedy Jr. unilaterally revoked and altered some of the CDC’s recommendations for COVID-19 vaccines, restricting access to children and pregnant people. The resignation also comes three weeks before CDC’s experts and advisors are scheduled to meet to publicly evaluate data and discuss the recommendations for this season—a long-established process that was disrupted by Kennedy’s announcement.

The departing CDC official, Lakshmi Panagiotakopoulos, a pediatric infectious disease expert, was a co-leader of a working group on COVID-19 vaccines who advised experts on the CDC’s Advisory Committee on Immunization Practices (ACIP). She informed her ACIP colleagues of her resignation in an email on Tuesday.

“My career in public health and vaccinology started with a deep-seated desire to help the most vulnerable members of our population, and that is not something I am able to continue doing in this role,” Panagiotakopoulos wrote.

Unilateral changes

Previously, the CDC and ACIP recommended COVID-19 vaccines for everyone ages 6 months and up. Experts have emphasized that pregnant people in particular should get vaccinated, as pregnancy suppresses the immune system and puts pregnant people at high risk of severe COVID-19 and death. The American College of Obstetricians and Gynecologists states that “COVID-19 infection during pregnancy can be catastrophic.” Further, dozens of studies have found that the vaccines are safe and effective at protecting the pregnant person, the pregnancy, and newborns.

Top CDC COVID vaccine expert resigns after RFK Jr. unilaterally restricts access Read More »

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RFK Jr. calls WHO “moribund” amid US withdrawal; China pledges to give $500M

“WHO’s priorities have increasingly reflected the biases and interests of corporate medicine,” Kennedy said, alluding to his anti-vaccine and germ-theory denialist views. He chastised the health organization for allegedly capitulating to China and working with the country to “promote the fiction that COVID originated in bats.”

Kennedy ended the short speech by touting his Make America Healthy Again agenda. He also urged the WHO to undergo a radical overhaul similar to what the Trump administration is currently doing to the US government—presumably including dismantling and withholding funding from critical health agencies and programs. Last, he pitched other countries to join the US in abandoning the WHO.

“I would like to take this opportunity to invite my fellow health ministers around the world into a new era of cooperation…. we’re ready to work with you,” Kennedy said.

Meanwhile, the WHA embraced collaboration. During the assembly this week, WHO overwhelmingly voted to adopt the world’s first pandemic treaty, aimed at collectively preventing, preparing for, and responding to any future pandemics. The treaty took over three years to negotiate, but in the end, no country voted against it—124 votes in favor, 11 abstentions, and no objections. (The US, no longer being a member of WHO, did not have a vote.)

“The world is safer today thanks to the leadership, collaboration and commitment of our Member States to adopt the historic WHO Pandemic Agreement,” WHO Director-General Tedros Adhanom Ghebreyesus said. “The Agreement is a victory for public health, science and multilateral action. It will ensure we, collectively, can better protect the world from future pandemic threats. It is also a recognition by the international community that our citizens, societies and economies must not be left vulnerable to again suffer losses like those endured during COVID-19.”

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under-rfk-jr.,-covid-shots-will-only-be-available-to-people-65+,-high-risk-groups

Under RFK Jr., COVID shots will only be available to people 65+, high-risk groups


FDA will require big, pricy trials for approvals for healthy kids and adults

U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. testifies before the Senate Committee on Health, Education, Labor, and Pensions on Capitol Hill on May 20, 2025 in Washington, DC. Credit: Getty | Tasos Katopodis

Under the control of anti-vaccine advocate Robert F. Kennedy Jr., the Food and Drug Administration is unilaterally terminating universal access to seasonal COVID-19 vaccines; instead, only people who are age 65 years and older and people with underlying conditions that put them at risk of severe COVID-19 will have access to seasonal boosters moving forward.

The move was laid out in a commentary article published today in the New England Journal of Medicine, written by Trump administration FDA Commissioner Martin Makary and the agency’s new top vaccine regulator, Vinay Prasad.

The article lays out a new framework for approving seasonal COVID-19 vaccines, as well as a rationale for the change—which was made without input from independent advisory committees for the Food and Drug Administration and the Centers for Disease Control and Prevention.

Normally, the FDA’s VRBPAC (Vaccines and Related Biological Products Advisory Committee) and the CDC’s ACIP (Advisory Committee on Immunization Practices) would publicly review, evaluate, and discuss vaccine approvals and recommendations. Typically, the FDA’s scope focuses on licensure decisions, made with strong influence from VRBPAC, while the CDC’s ACIP is principally responsible for influencing the CDC’s more nuanced recommendations on usage, such as for specific age or risk groups. These recommendations shape clinical practice and, importantly, health insurance coverage.

Makary and Prasad appear to have foregone those norms, even though VRBPAC is set to meet this Thursday to discuss COVID-19 vaccines for the upcoming season.

Restrictions

In the commentary, Markary and Prasad puzzlingly argue that the previous universal access to COVID-19 vaccines was patronizing to Americans. They describe the country’s approach to COVID boosters as a “one-size-fits-all” and write that “the US policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations. We reject this view.”

Previously, the seasonally updated vaccines were available to anyone age 6 months and up. Further, people age 65 and older and those at high risk were able to get two or more shots, based on their risk. So, while Makary and Prasad ostensibly reject the view of Americans as being too unsophisticated to understand risk-based usage, the pair are installing restrictions to force their own idea of risk-based usage.

Even more puzzlingly, in an April meeting of ACIP, the expert advisors expressed clear support for shifting from universal recommendations for COVID-19 boosters to recommendations based on risk. Specifically, advisors were supportive of urging boosters for people age 65 and older and people who are at risk of severe COVID-19—the same restrictions that Makary and Prasad are forcing. The two regulators do not mention this in their NEJM commentary. ACIP would also likely recommend a primary series of seasonally matched COVID-19 vaccines for very young children who have not been previously exposed to the virus or vaccinated.

ACIP will meet again in June, but without a permissive license from the FDA, ACIP’s recommendations for risk-based usage of this season’s COVID-19 shots are virtually irrelevant. And they cannot recommend usage in groups that the FDA licensure does not cover. It’s unclear if a primary series for young children will be available and, if so, how that will be handled moving forward.

New vaccine framework

Under Makary and Prasad’s new framework, seasonally updated COVID-19 vaccines can continue to be approved annually using only immunology studies—but the approvals will only be for people age 65 and over and people who are at high risk. These immunology studies look at antibody responses to boosters, which offer a shorthand for efficacy in updated vaccines that have already been through rigorous safety and efficacy trials. This is how seasonal flu shots are approved each year and how COVID boosters have been approved for all people age 6 months and up—until now.

Moving forward, if a vaccine maker wants to have their COVID-19 vaccine also approved for use in healthy children and healthy adults under age 65, they will have to conduct large, randomized, placebo-controlled studies. These may need to include tens of thousands of participants, especially with high levels of immunity in the population now. These trials can easily cost hundreds of millions of dollars, and they can take many months to complete. The requirement for such trials will make it difficult, if not impossible, for drug makers to conduct them each year and within a timeframe that will allow for seasonal shots to complete the trial, get regulatory approval, and be produced at scale in time for the start of the respiratory virus season.

Makary and Prasad did not provide any data analysis or evidence-based reasoning for why additional trials would be needed to continue seasonal approvals. In fact, the commentary had a total of only eight references, including an opinion piece Makary published in Newsweek and a New York Times article.

“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,” they argue in their commentary.

Their new framework does not make any mention of what will happen if a more dangerous SARS-CoV-2 variant emerges. It also made no mention of vaccine usage in people who are in close contact with high-risk groups, such as ICU nurses or family members of immunocompromised people.

Context

Another lingering question from the framework is how easy it will be for people deemed at high risk to get access to seasonal shots. Makary and Prasad lay out a long list of conditions that would put people at risk of severe COVID-19 and therefore make them eligible for a seasonal booster. The list includes: obesity; asthma; lung diseases; HIV; diabetes; pregnancy; gestational diabetes; heart conditions; use of corticosteroids; dementia; physical inactivity; mental health conditions, including depression; and smoking, current or former. The FDA leaders estimate that between 100 million and 200 million Americans will fit into the category of being at high risk. It’s unclear what such a large group of Americans will need to do to establish eligibility every year.

In all, the FDA’s move to restrict and hinder access to seasonal COVID-19 vaccines is in line with Kennedy’s influential anti-vaccine advocacy work. In 2021, prior to taking the role of the country’s top health official, Kennedy and the anti-vaccine organization he founded, Children’s Health Defense, petitioned the FDA to revoke authorizations for COVID-19 vaccines and refrain from issuing any approvals.

Ironically, Makary and Prasad blame the country’s COVID-19 policies for helping to erode Americans’ trust in vaccines broadly.

“There may even be a ripple effect: public trust in vaccination in general has declined, resulting in a reluctance to vaccinate that is affecting even vital immunization programs such as that for measles–mumps–rubella (MMR) vaccination, which has been clearly established as safe and highly effective,” the two write, including the most full-throated endorsement of the MMR vaccine the Trump administration has issued yet. Kennedy continues to spread misinformation about the vaccine, including the false and debunked idea that it causes autism.

“Against this context, the Food and Drug Administration seeks to provide guidance and foster evidence generation,” Makary and Prasad write.

Photo of Beth Mole

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

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germ-theory-skeptic-rfk-jr.-goes-swimming-in-sewage-tainted-water

Germ-theory skeptic RFK Jr. goes swimming in sewage-tainted water

When you don’t believe in germ theory, the world is your oyster—or maybe your bathtub.

Over the weekend, America’s top health official, Robert F. Kennedy Jr., shared pictures on social media of himself fully submerged in the sewage-tinged waters of Rock Creek in Washington, DC. His grandchildren were also pictured playing in the water.

The creek is known for having a sewage overflow problem and posing a health hazard to any who enter it. The National Park Service, which manages the Rock Creek Park, strictly bars all swimming and wading in Rock Creek and the park’s other waterways due to the contamination, specifically “high levels of bacteria.”

A notice on the NPS website advises “Stay Dry, Stay Safe,” warning, “Rock Creek has high levels of bacteria and other infectious pathogens that make swimming, wading, and other contact with the water a hazard to human (and pet) health. Please protect yourself and your pooches by staying on trails and out of the creek. All District waterways are subject to a swim ban—this means wading, too!”

In images shared on social media, Kennedy can be seen getting fully underwater, including his head, and then splashing around with several of his grandchildren. Kennedy, who does not have any background in medicine or science, was a long-time anti-vaccine advocate before President Trump appointed him to be health secretary. In a 2021 book, Kennedy indicated that he does not believe in germ theory, the fundamental concept that microscopic pathogens, such as those abundant in sewage, are the cause of disease.

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