CDC

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.

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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 »

new-covid-variant-swiftly-gains-ground-in-us;-concern-looms-for-summer-wave

New COVID variant swiftly gains ground in US; concern looms for summer wave

While COVID-19 transmission remains low in the US, health experts are anxious about the potential for a big summer wave as two factors seem set for a collision course: a lull in infection activity that suggests protective responses have likely waned in the population, and a new SARS-CoV-2 variant with an infectious advantage over other variants.

The new variant is dubbed NB.1.8.1. Like all the other currently circulating variants, it’s a descendant of omicron. Specifically, NB.1.8.1 is derived from the recombinant variant XDV.1.5.1. Compared to the reigning omicron variants JN.1 and LP.8.1, the new variant has a few mutations that could help it bind to human cells more easily and evade some protective immune responses.

On May 23, the World Health Organization designated NB.1.8.1 a “variant under monitoring,” meaning that early signals indicate it has an advantage over other variants, but its impact on populations is not yet clear. In recent weeks, parts of Asia, including China, Hong Kong, Singapore, and Taiwan, have experienced increases in infections and hospitalizations linked to NB.1.8.1’s spread. Fortunately, the variant does not appear to cause more severe disease, and current vaccines are expected to remain effective against it.

Still, it appears to be swiftly gaining ground in the US, fueling worries that it could cause a surge here as well. In the latest tracking data from the Centers for Disease Control and Prevention, NB.1.8.1 is estimated to account for 37 percent of cases in the US. That’s up from 15 percent two weeks ago. NB.1.8.1 is now poised to overtake LP.8.1, which is estimated to make up 38 percent of cases.

It’s important to note that those estimates are based on limited data, so the CDC cautions that there are large possible ranges for the variants’ actual proportions. For NB.1.81, the potential percentage of cases ranges from 13 percent to 68 percent, while LP.8.1’s is 23 percent to 57 percent.

New COVID variant swiftly gains ground in US; concern looms for summer wave Read More »

rfk-jr.-announces-8-appointees-to-cdc-vaccine-panel—they’re-not-good

RFK Jr. announces 8 appointees to CDC vaccine panel—they’re not good

Anti-vaccine advocate and current Health Secretary Robert F. Kennedy Jr. took to social media Wednesday to announce the names of eight people he is appointing to a critical federal vaccine advisory committee—which is currently empty after Kennedy abruptly fired all 17 previous members Monday.

In the past, the vetting process for appointing new members to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) could take years. But Kennedy has taken just two days.

The panel, typically stocked with vaccine, infectious disease, and public health experts, carefully and publicly reviews, analyzes, and debates vaccine data and offers recommendations to the CDC via votes. The CDC typically adopts the recommendations, which set clinical practices nationwide and determine insurance coverage for vaccinations.

Yesterday, Kennedy pledged that none of the new ACIP members would be “ideological anti-vaxxers.” However, the list of today’s appointees includes Robert Malone, who falsely claims to have invented mRNA vaccines and has spent the past several years spreading misinformation and conspiracy theories about them.

Speaking at an anti-vaccine rally in 2022, Malone spread dangerous falsehoods about mRNA COVID-19 vaccines: “These genetic vaccines can damage your children. They may damage their brains, their heart, their immune system and their ability to have children in the future. Many of these damages cannot be repaired.”

Troubling list

Malone aligned with the anti-vaccine crowd during the pandemic and has become a mainstay in conspiratorial circles and an ally to Kennedy. He has claimed that vaccines cause a “form of AIDS,” amid other nonsense. He has also meddled with responses to the measles outbreak that erupted in West Texas in January. In April, Malone was the first to publicize news that a second child had died from the highly infectious and serious infection, but he did so to falsely claim that measles wasn’t the cause and spread other dangerous misinformation.

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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-advocate-rfk-jr.-fires-entire-cdc-panel-of-vaccine-advisors

Anti-vaccine advocate RFK Jr. fires entire CDC panel of vaccine advisors

“Most likely aim to serve the public interest as they understand it,” he wrote. “The problem is their immersion in a system of industry-aligned incentives and paradigms that enforce a narrow pro-industry orthodoxy.”

Kennedy, who is currently trying to shift the national attention to his idea of clean living and higher-quality foods, has a long history of advocating against vaccines, spreading misinformation and disinformation about the lifesaving shots. However, a clearer explanation of Kennedy’s war on vaccines can be found in his rejection of germ theory. In his 2021 book that vilifies infectious disease expert Anthony Fauci, he bemoaned germ theory as “the pharmaceutical paradigm that emphasized targeting particular germs with specific drugs rather than fortifying the immune system through healthy living, clean water, and good nutrition.”

As such, he rails against the “$1 trillion pharmaceutical industry pushing patented pills, powders, pricks, potions, and poisons.”

In Kennedy’s op-ed, he indicates that new ACIP members will be appointed who “won’t directly work for the vaccine industry. … will exercise independent judgment, refuse to serve as a rubber stamp, and foster a culture of critical inquiry.”

It’s unclear how the new members will be vetted and appointed and when the new committee will be assembled.

In a statement, the president of the American Medical Association, Bruce Scott, rebuked Kennedy’s firings, saying that ACIP “has been a trusted national source of science- and data-driven advice and guidance on the use of vaccines to prevent and control disease.” Today’s removal “undermines that trust and upends a transparent process that has saved countless lives,” he continued. “With an ongoing measles outbreak and routine child vaccination rates declining, this move will further fuel the spread of vaccine-preventable illnesses.”

This post has been updated to include a statement from the AMA. This story is breaking and may be updated further.

Anti-vaccine advocate RFK Jr. fires entire CDC panel of vaccine advisors 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 »

cdc-updates-covid-vaccine-recommendations,-but-not-how-rfk-jr.-wanted

CDC updates COVID vaccine recommendations, but not how RFK Jr. wanted

In practice, it is unclear how this change will affect access to the vaccines. Health insurers are required to cover vaccines on the CDC schedules. But, it’s yet to be seen if children will only be able to get vaccinated at their doctor’s office (rather than a pharmacy or vaccine clinic) or if additional consent forms would be required, etc. Uncertainty about the changes and requirements alone may lead to fewer children getting vaccinated.

In the adult immunization schedule, when viewed “by medical condition or other indication” (table 2), the COVID-19 vaccination recommendation for pregnancy is now shaded gray, meaning “no guidance/not applicable.” Hovering a cursor over the box brings up the recommendation to “Delay vaccination until after pregnancy if vaccine is indicated.” Previously, COVID-19 vaccines were recommended during pregnancy. The change makes it less likely that health insurers will cover the cost of vaccination during pregnancy.

The change is at odds with Trump’s Food and Drug Administration, which just last week confirmed that pregnancy puts people at increased risk of severe COVID-19 and, therefore, vaccination is recommended. Medical experts have decried the loss of the recommendation, which is also at odds with clear data showing the risks of COVID-19 during pregnancy and the benefits of vaccination.

The President of the American College of Obstetricians and Gynecologists (ACOG) put out a statement shortly after the Tuesday video, saying that the organization was “extremely disappointed” with Kennedy’s announcement.

“It is very clear that COVID-19 infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families,” ACOG President Steven Fleischman said.

CDC updates COVID vaccine recommendations, but not how RFK Jr. wanted Read More »

cdc-can-no-longer-help-prevent-lead-poisoning-in-children,-state-officials-say

CDC can no longer help prevent lead poisoning in children, state officials say

Amid the brutal cuts across the federal government under the Trump administration, perhaps one of the most gutting is the loss of experts at the Centers for Disease Control and Prevention who respond to lead poisoning in children.

On April 1, the staff of the CDC’s Childhood Lead Poisoning Prevention Program was terminated as part of the agency’s reduction in force, according to NPR. The staff included epidemiologists, statisticians, and advisors who specialized in lead exposures and responses.

The cuts were immediately consequential to health officials in Milwaukee, who are currently dealing with a lead exposure crisis in public schools. Six schools have had to close, displacing 1,800 students. In April, the city requested help from the CDC’s lead experts, but the request was denied—there was no one left to help.

In a Congressional hearing this week, US health secretary and anti-vaccine advocate Robert F. Kennedy Jr. told lawmakers, “We have a team in Milwaukee.”

But Milwaukee Health Commissioner Mike Totoraitis told NPR that this is false. “There is no team in Milwaukee,” he said. “We had a single [federal] staff person come to Milwaukee for a brief period to help validate a machine, but that was separate from the formal request that we had for a small team to actually come to Milwaukee for our Milwaukee Public Schools investigation and ongoing support there.”

Kennedy has also previously told lawmakers that lead experts at the CDC who were terminated would be rehired. But that statement was also false. The health department’s own communications team told ABC that the lead experts would not be reinstated.

CDC can no longer help prevent lead poisoning in children, state officials say Read More »

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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a-dangerous-e.-coli-strain-has-emerged;-a-small-mutation-may-explain-its-rise

A dangerous E. coli strain has emerged; a small mutation may explain its rise

Small change

The CDC researchers identified the EspW mutation by comparing the genetic sequences of 729 isolates of the new E. coli strain—dubbed REPEXH01—to genetic sequences of 2,027 other E. coli O157:H7 isolates. Of the 729 REPEXH01 strains, all but two had a single nucleotide deletion in EspW (the remaining two had ambiguous sequences), while the deletion was present in less than 4 percent of the non-REPEXH01 E. coli strains. The finding suggests the tiny change could be a genetic signature of the strain, and its persistence in a key disease protein may offer the strain an advantage.

For now, it’s unclear what that advantage might be. The deletion of a single DNA base (an adenine) shifts the frame of the three-sequence protein code for the rest of EspW. This could result in a shorter protein. It could also cause the molecular machinery that translates the genetic code to slip, leading to proteins of various lengths. In any case, the deletion is likely to result in a less fully functional EspW protein.

The CDC researchers suggest this could help E. coli when it’s on lettuce and other produce. For example, EspW might spur an immune response from an infected plant that causes stomata—pores on the surfaces of leaves—to close, blocking the bacteria’s ability to invade. Thus, cutting back EspW may help E. coli sneak in—an adaptation in the ongoing arms race between the bacteria and its host. Another possibility is that EspW could function like HopW1, leading to more severe infection in plant tissues, which could lower the chances that those infected leaves are harvested and make it to grocery stores and atop burgers. Thus, cutting back on EspW could help E. coli move to its human victims.

Ultimately, additional research will be needed to understand what’s going on. As the CDC researchers conclude: “the role of the single base pair mutation in this strain’s colonization and survival on leafy vegetables could yield valuable insights.”

A dangerous E. coli strain has emerged; a small mutation may explain its rise Read More »

texas-goes-after-toothpaste-in-escalating-fight-over-fluoride

Texas goes after toothpaste in escalating fight over fluoride

Texas Attorney General Ken Paxton is investigating two leading toothpaste makers over their use of fluoride, suggesting that they are “illegally marketing” the teeth cleaners to parents and kids “in ways that are misleading, deceptive, and dangerous.”

The toothpaste makers in the crosshairs are Colgate-Palmolive Company, maker of Colgate toothpastes, and Proctor & Gamble Manufacturing Co., which makes Crest toothpastes. In an announcement Thursday, Paxton said he has sent Civil Investigative Demands (CIDs) to the companies.

The move is an escalation in an ongoing battle over fluoride, which effectively prevents dental cavities and improves oral health. Community water fluoridation has been hailed by health and dental experts as one of the top 10 great public health interventions for advancing oral health across communities, regardless of age, education, or income. But, despite the success, fluoride has always had detractors—from conspiracy theorists in the past suggesting the naturally occurring mineral is a form of communist mind control, to more recent times, in which low-quality, controversial studies have suggested that high doses may lower IQ in children.

The debate was renewed earlier this year when the National Toxicology Program at the National Institute of Environmental Health Sciences finally published a particularly contentious study after years of failed scientific reviews. The study claims to find a link between high levels of fluoride exposure and slightly lower IQs in children living in areas outside the US, mostly in China and India. But the study’s methodology, statistical rigor, risk of bias, and lack of data transparency continue to draw criticism.

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