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‘I'm Not Quite Sure How to Respond to This Presentation'
‘I'm Not Quite Sure How to Respond to This Presentation'

Atlantic

time5 hours ago

  • Health
  • Atlantic

‘I'm Not Quite Sure How to Respond to This Presentation'

The past three weeks have been auspicious for the anti-vaxxers. On June 9, Health Secretary Robert F. Kennedy Jr. purged the nation's most important panel of vaccine experts: All 17 voting members of the CDC's Advisory Committee on Immunization Practices (ACIP), which sets recommendations for the use of vaccines and determines which ones must be covered through insurance and provided free of charge to children on Medicaid, were abruptly fired. The small, ragtag crew of replacements that Kennedy appointed two days later met this week for the first time, amid lots of empty chairs in a conference room in Atlanta. They had come to talk about the safety of vaccines: to raise concerns about the data, to float hypotheses of harm, to issue findings. The resulting spectacle was set against a backdrop of accelerating action from the secretary. On Wednesday, Kennedy terminated more than $1 billion in U.S. funding for Gavi, a global-health initiative that supports the vaccination of more than 65 million children every year. Lyn Redwood, a nurse practitioner and the former president of Children's Health Defense, the anti-vaccine organization that Kennedy used to chair, was just hired as a special government employee. (She presented at the ACIP meeting yesterday.) A recently posted scientific document on the ACIP website that underscored the safety of thimerosal, an ingredient in a small proportion of the nation's flu vaccines, had been taken down, a committee member said, because the document 'was not authorized by the office of the secretary.' (A spokesperson for the Department of Health and Human Services told me in an email that this document was provided to the ACIP members in their meeting briefing packets.) What's clear enough is that, 61 years after ACIP's founding, America's vaccination policy is about to be recooked. Now we've had a glimpse inside the kitchen. The meeting started with complaints. 'Some media outlets have been very harsh on the new members of this committee,' said Martin Kulldorff, a rangy Swedish biostatistician and noted COVID contrarian who is now ACIP's chair. (Kuldorff was one of the lead authors of the Great Barrington Declaration, a controversial proposal from the fall of 2020 to isolate seniors and other vulnerable people while reopening the rest of society.) In suggesting that he and Kennedy's other appointees are opposed to vaccination, Kulldorff said, journalists were misleading the public, weakening trust in public health, and fanning 'the flames of vaccine hesitancy.' This was, in fact, the most pugnacious comment of the two-day meeting, which otherwise unfolded in a tone of fearmongering gentility. Robert Malone, a doctor and an infectious-diseases researcher who has embraced the 'anti-vaccine' label and published a conspiracy-theory-laden book that details government psyops against the American people, was unfailingly polite in his frequent intimations about the safety of vaccines, often thanking CDC staff for their hard work and lucid presentations. With his thick white beard, calm affect, and soldierly diction—Malone ended many of his comments by saying, 'Over' into the microphone—he presented less as a firebrand than as, say, the commanding officer of a submarine. When Malone alluded to the worry, for example, that spike proteins from the mRNA-based COVID vaccines linger in the body following injection, he did so in respectful, even deferential, language, suggesting that the public would benefit from greater study of possible 'delayed effects' of immune-system activation. The CDC's traditional approach—its 'world-leading, rigorous' one, he clarified—might be improved by examining this question. A subject-matter expert responded that the CDC has been keeping tabs on real-world safety data on those vaccines for nearly five years, and has not detected any signs of long-term harm. Later, Malone implied that COVID or its treatments might have, through some unspecified, bank-shot mechanism, left the U.S. population more susceptible to other illnesses. There was a 'paradoxical, sudden decrease' in flu cases in 2020 and 2021, he noted, followed by a trend of worsening harm. A CDC staffer pointed out that the decrease in flu during those years was not, in fact, a paradox; well-documented shifts in people's health behavior had temporarily reduced the load of many respiratory illnesses during that same period. But Malone pressed on: 'Some members of the scientific community have concern that they're coming out of the COVID pandemic—exposure to the virus, exposure to various countermeasures—there may be a pattern of broad-based, uh, energy,' he said, his eyes darting up for a moment as he said the word, 'that might contribute to increased severity of influenza disease.' He encouraged the agency to 'be sensitive to that hypothesis.' Throughout these and other questions from the committee members, the CDC's subject-matter experts did their best to explain their work and respond to scattershot technical and conceptual concerns. 'The CDC staff is still attempting to operate as an evidence-based organization,' Laura Morris, a professor at the University of Missouri School of Medicine, who has attended dozens of ACIP meetings in the past and attended this one as a nonvoting liaison to the committee from the American Academy of Family Physicians, told me. 'There was some tension in terms of the capacity of the committee to ask and understand the appropriate methodological questions. The CDC was trying to hold it down.' That task became more difficult as the meeting progressed. 'The new ACIP is an independent body composed of experienced medical and public health experts who evaluate evidence, ask hard questions, and make decisions based on scientific integrity,' the HHS spokesperson told me. 'Bottom line: this process reflects open scientific inquiry and robust debate, not a pre-scripted narrative.' The most vocal questioner among the new recruits—and the one who seemed least beholden to a script—was the MIT business-school professor Retsef Levi, a lesser-known committee appointee who sat across the table from Malone. A scruffy former Israel Defense Forces intelligence officer with a ponytail that reached halfway down his back, Levi's academic background is in data modeling, risk management, and organizational logistics. He approached the proceedings with a swaggering incredulity, challenging the staffers' efforts and pointing out the risks of systematic errors in their thinking. (In a pinned post on his X profile, Levi writes that 'the evidence is mounting and indisputable that mRNA vaccines cause serious harm including death'—a position entirely at odds with copious data presented at the meeting.) Shortly before the committee's vote to recommend a new, FDA-approved monoclonal antibody for preventing RSV in infants, Levi noted that he'd spent some time reviewing the relevant clinical-trial data for the drug and another like it, and found some worrying patterns in the statistics surrounding infant deaths. 'Should we not be concerned that maybe there are some potential safety signals?' he asked. But these very data had already been reviewed, at great length, in multiple settings: by the FDA, in the course of drug approval, and by the dozens of members of ACIP's relevant work group for RSV, which had, per the committee's standard practice, conducted its own staged analysis of the new treatment before the meeting and reached consensus that its benefits outweighed its risks. Levi was uncowed by any reference to this prior work. 'I'm a scientist, but I'm also a father of six kids,' he told the group; speaking as a father, he said, he personally would be concerned about the risk of harm from this new antibody for RSV. In the end, Levi voted against recommending the antibody, as did Vicky Pebsworth, who is on the board of an anti-vaccine organization and holds a Ph.D. in public health and nursing. The five other members voted yes. That 5–2 vote aside, the most contentious issue on the meeting's schedule concerned the flu shots in America that contain thimerosal, which has been an obsession of the anti-vaccine movement for the past few decades. Despite extensive study, vaccines with thimerosal have not been found to be associated with any known harm in human patients, yet an unspecified vote regarding their use was slipped into the meeting's agenda in the absence of any work-group study or presentation from the CDC's staff scientists. What facts there were came almost exclusively from Redwood, the nurse who used to run Kennedy's anti-vaccine organization. Earlier this week, Reuters reported that at least one citation from her posted slides had been invented. That reference was removed before she spoke yesterday. (HHS did not address a request for comment on this issue in its response to me.) The only one of Kennedy's appointees who had ever previously served on the committee—the pediatrician Cody Meissner—seemed perplexed, even pained, by the proceedings. 'I'm not quite sure how to respond to this presentation,' he said when Redwood finished. He went on to sum up his concerns: 'ACIP makes recommendations based on scientific evidence as much as possible. And there is no scientific evidence that thimerosal has caused a problem.' Alas, Meissner's warnings were for nought. Throughout the meeting, he came off as the committee's last remaining, classic 'expert'—a vaccine scientist clinging to ACIP's old ways—but his frequent protestations were often bulldozed over or ignored. In the end, his was the only vote against the resolutions on thimerosal. Throughout the two-day meeting, Kuldorff kept returning to a favorite phrase: evidence-based medicine. 'Secretary Kennedy has given this committee a clear mandate to use evidence-based medicine,' he said on Wednesday morning; 'The purpose of this committee is to follow evidence-based medicine,' he said on Wednesday afternoon; 'What is important is using evidence-based medicine,' he said again when the meeting reached its end. All told, I heard him say evidence-based at least 10 times during the meeting. (To be fair, critics of Kuldorff and his colleagues also love this phrase.) But the committee was erratic in its posture toward the evidence from the very start; it cast doubt on CDC analyses and substituted lay advice and intuition for ACIP's normal methods of assessing and producing expert consensus. 'Decisons were made based on feelings and preferences rather than evidence,' Morris told me after the meeting. 'That's a dangerous way to make public-health policy.'

Former CDC staffers ring alarm bells over decisions of new US vaccine panel
Former CDC staffers ring alarm bells over decisions of new US vaccine panel

SBS Australia

time5 hours ago

  • Health
  • SBS Australia

Former CDC staffers ring alarm bells over decisions of new US vaccine panel

Every week for a number of weeks, current and former employees of the US Centres for Disease Control and Prevention have been blowing whistles and banging drums at a street intersection near the group's headquarters in Atlanta, Georgia. They're protesting changes to the US Department of Health now led by Robert F Kennedy Jr, saying that he has brought his long history of vaccine scepticism into his role as the nation's top health official. Among the demonstrators is infectious diseases physician Peter Cegielski. "There have been rallies here every Tuesday maybe since March... The public needs to mobilise because, I mean, there's a clown show running this country and DHHS." The CDC protesters' appearance on the Atlanta corner this week was timed to coincide with the first meeting of the reconstituted US panel known as ACIP or the Advisory Committee on Immunisation Practices. Kennedy abruptly fired all 17 previous members earlier this month after accusing them without evidence of conflicts of interest, replacing them with seven handpicked others. Among them is new Committee chair Dr Martin Kulldorff, a biostatistician and epidemiologist who publicly criticised COVID-19 lockdowns and was fired from Harvard for refusing to take a COVID vaccine. Dr Kulldorff was one of five members at the meeting to vote for a recommendation that people aged 6 months and older get a flu vaccination only using a single dose formula which is thimerosal-free. "Even if the amount available in the vaccine, maybe that amount is safe - but does not amount for exposed to be exposed to mercury from other sources. So it's cumulative and there is a need. And if we care about public health we should try to minimise exposure to mercury." The reason why that's important is because the panel's recommendations influence the official US immunisation schedule, determine insurance coverage for vaccines, and act as an encouragement for people to get vaccinated. Thimerosal is widely used in lower income countries because they are more likely to use lower cost multidose containers that must be punctured repeatedly, raising the risk of contamination which thimerosal helps to prevent. But the preservative has also been at the centre of controversies and myths about vaccines for decades, with Robert F Kennedy involved in some of that debate. In 2014, when Kennedy was an environmental lawyer, he appeared on Fox 5 New York to promote a book he had published called 'Thimerosal' that alleged evidence had been covered up showing it could cause brain problems, including autism. "You know I've had all six of my children vaccinated. I want to see everybody taking their vaccines. We need full coverage. People don't take them (vaccines) because they no longer believe in the CDC. They can see the science." The CDC says it conducted nine separate studies since 2003 that found no link between thimerosal-containing vaccines and ASD or Autism Spectrum Disorder, and that multiple scientific studies have found no evidence of a link either. The CDC was not given an opportunity to present evidence before the committee's vote - but Lyn Redwood, the former president of what is now known as Children's Health Defense, an antivaccine group founded by Secretary Kennedy - did air her concerns about thimerosal. "Thimerosal is recognised as a developmental and reproductive toxicant, and is listed as a chemical in the California Proposition 65 list since 1990." Secretary Kennedy has maintained he has always just asked questions that are justifiable and necessary, arguing that the public's trust in vaccines has waned because those questions have not been answered satisfactorily. "We're living now in a time of upheaval, a time of popular revolt against established institutions that have lost the public trust - and that includes medicine. President Trump and I are committed to earning it back." But at least two CDC staff members have left over the changes, and major medical experts and former members of the panel have also expressed concern over its reconstitution. Georgia State Senator for District 42 Elena Parent says the panel is essentially embedding false information and vaccine scepticism into national policy. "This is the very body that has guided our nation's policies for vaccines for over 60 years. And by the way, this is what everyone said when they said 'do not confirm him'. Do not confirm him as the secretary of health. Anyone who knew anything about public health and vaccines said 'no'. These guy has peddled disinformation for years. And what did they do? Fell in line behind Trump and all the rest of them and put him in. And the worst fears are now coming true with this assault on the ACIP." The Secretary's views have also received a cool reception at a Brussels fundraising dinner for the GAVI global vaccine alliance, a group that facilitates immunisations in lower-income countries. In a video recording played to the gathering, Kennedy cast doubt on the diphtheria, tetanus and pertussis vaccines — which the World Health Organisation and other agencies have long deemed to be safe and effective. He also announced the US will be cutting its funding to GAVI, on the basis that they have allegedly silenced dissenting views and what he has described as legitimate questions about vaccine safety. "Consider the best science available even when the science contradicts established paradigms. Until that happens, the United States won't contribute more to GAVI." GAVI says that's ridiculous. Chairman of the Board Jose Manuel Barroso says the organisation has multiple safeguards and processes in place to prioritise the health and safety of children. "Gavi is indeed a unique organisation in global health with a public-private model that has brought together national governments, donors, vaccine manufacturers, scientific institutes and grassroot organisations to vaccinate more than 1 billion children in low income and middle income countries. And I have to say that Gavi has done it always following the best scientific advice." Doctors Without Borders is among the medical groups to say they believe countless children will die from vaccine-preventable diseases as a result of the U-S withdrawing support for Gavi. The charity's global health advocacy director, Mihir Mankad, has called it cruel and reckless to invoke misleading and inaccurate claims about vaccine safety as the pretext for cutting all global vaccine funding. But GAVI says it will be able to continue much of its work, and has plenty of other willing donors. Australia's Foreign Minister Penny Wong has said in a statement that Australia is sending $386 million over five years, while European Union President Ursula von der Leyen has also committed money. "Today I am pleased to pledge 360 million Euros to GAVI at this summit, and this is part of a total Team Europe pledge of 2 billion Euros or even more." Meanwhile, back in the US, some doctors are taking matters into their own hands. The influential American Academy of Paediatrics boycotted A-C-I-P's first meeting in protest, saying it will now publish its own vaccine schedule for children and do so independently of the vaccine panel, calling it 'no longer a credible process.' And the CDC demonstrators - which include former Division of Overdose Prevention public servant, Abby Tighe - say they will keep ringing their protest bells on that Atlanta corner for as long as they can. "Let's make it a non political conversation. We have to do the work to de-politicise public health. And I know it's hard and it sucks, but we have to do it because people's lives are at stake."

U.S. vaccine panel rejects flu shots with a specific preservative, despite safety data
U.S. vaccine panel rejects flu shots with a specific preservative, despite safety data

CBC

time9 hours ago

  • Health
  • CBC

U.S. vaccine panel rejects flu shots with a specific preservative, despite safety data

The Trump administration's new vaccine advisers on Thursday endorsed this fall's flu vaccinations for just about every American — but only if they use certain shots free of a preservative that has been safely used in vaccines for decades. What is normally a routine step in preparing for the upcoming flu season drew intense scrutiny after U.S. Health Secretary Robert F. Kennedy Jr. abruptly fired the influential 17-member Advisory Committee on Immunization Practices (ACIP)and handpicked replacements that include several vaccine skeptics. The seven-member panel bucked another norm Thursday as it discussed the safety of a preservative used in less than five per cent of U.S. flu vaccinations: It deliberated based only on a presentation from an anti-vaccine group's former leader — without allowing the usual public airing of scientific data from the U.S. Centers for Disease Control and Prevention. The preservative, thimerosal, has been used for decades in certain vaccines that come in multi-dose vials, to prevent contamination as each dose is withdrawn. Its controversy stems from containing a small amount of a particular type of mercury. However, the CDC's own data shows it is safe, and on Friday the World Health Organization stated in a press briefing that there was no evidence of risk. "Thimerosal has been reviewed multiple times by multiple agencies, including WHO, and it's clear from the evidence that there is no evidence of harm from the use of thimerosal," Dr. Katherine O'Brien from WHO told reporters in reaction to the U.S. panel decision. Thimerosal contains a minute amount of ethyl mercury, which breaks down quickly in the body and is swiftly removed, unlike methyl mercury, the type of mercury found in the environment which can build up in the body and cause harm. In Canada, a handful of multi-dose influenza vaccines approved for use by Health Canada contain thimerosal, but the vast majority of routine childhood vaccines do not. Single-dose flu shots unaffected Study after study has found no evidence that thimerosal causes autism, a myth long pushed by anti-vaccine groups, or poses any safety risks. Yet since 2001, all vaccines routinely used for U.S. children age 6 years or younger have already come in thimerosal-free formulas. The advisory panel voted to back the usual U.S. recommendation that nearly everyone age six months and older get an annual flu vaccination, but then voted 5-1 with one abstention that these had to be thimerosal-free formulations. This would include single-dose shots that already are the most common type of flu vaccination, and would rule out the subset of flu vaccine dispensed in multi-dose vials. "There is still no demonstrable evidence of harm," one panelist, Dr. Joseph Hibbeln, a psychiatrist formerly with the National Institutes of Health, said in acknowledging the committee wasn't following its usual practice of acting on evidence. But he argued that "we have to respect the fear of mercury" that he said might dissuade some people from getting vaccinated. Panel blocked CDC's analysis Lyn Redwood, formerly of the Kennedy-founded anti-vaccine group Children's Health Defense, gave the presentation on thimerosal in front of the panel, arguing that it was a neurotoxin. The version of Redwood's presentation posted to the CDC's website earlier this week initially included a reference to a study that does not exist. The report she gave to the committee was significantly shorter, removing a reference to that study and another slide saying she did not have any conflicts of interest. "With the vote on thimerosal this afternoon, the new committee has turned the ACIP process into a farce," said former CDC vaccine adviser Dr. Fiona Havers, who resigned last week over Kennedy's changes to vaccine policy. Medical groups decried the panel's lack of transparency in blocking a CDC analysis of thimerosal that concluded there was no link between the preservative and neurodevelopmental disorders, including autism. The data had been posted on the committee's website Tuesday, but was later removed — because, according to ACIP member Dr. Robert Malone, the report hadn't been authorized by Kennedy's office. Panel members said they had read it. The ACIP helps the CDC determine who should be vaccinated against a long list of diseases, and when, and its recommendations have a big impact on availability and insurance coverage of vaccines in the U.S. Normally the CDC's director would decide whether to accept ACIP's recommendation, but the Senate has not yet confirmed nominee Susan Monarez. Administration officials said Kennedy would make that decision. While Thursday's debate involved only a small fraction of flu vaccines, some public health experts contend the discussion unnecessarily raised doubt about vaccine safety. Already, fewer than half of Americans get their yearly flu vaccinations, and mistrust in vaccines overall is growing. "Selective use of data and omission of established science undermines public trust and fuels misinformation," said Dr. Sean O'Leary of the American Academy of Pediatrics (AAP). He said of the new panelists, "Nothing about their recent actions have been science-based or transparent." WATCH: Misinformation one of the factors behind decline in childhood vaccination globally: Decline in childhood vaccination fuelled by global conflicts, misinformation: Lancet 3 days ago Duration 2:01 A new study published in the Lancet medical journal suggests childhood vaccinations have stagnated or declined since 2010. The authors say geopolitical instability is fuelling the drop in some countries, but misinformation is largely driving the decline in high-income countries. The pediatrics group announced Wednesday that it would no longer be participating in the ACIP meetings, with president Sue Kressly saying in a video statement that "with the committee dismissals, it is no longer a credible process." The AAP will continue publishing its own vaccination recommendations. The flu votes marked the final step of a two-day meeting that alarmed pediatricians and other doctors' groups, who pointed to new panelists' lack of expertise in how to properly track vaccine safety — and a shift in focus which appears to boost anti-vaccine messaging. Of special concern was the announcement by panel chairman Martin Kulldorff to reevaluate the "cumulative effect" of the children's vaccine schedule — the list of immunizations given at different times throughout childhood. That reflects the scientifically debunked notion that children today get too many vaccinations for their immune systems.

CDC committee moves to phase out controversial mercury ingredient from flu vaccines
CDC committee moves to phase out controversial mercury ingredient from flu vaccines

Fox News

time12 hours ago

  • Health
  • Fox News

CDC committee moves to phase out controversial mercury ingredient from flu vaccines

Print Close By Melissa Rudy Published June 27, 2025 A vaccine ingredient is in the spotlight this week, as a preservative called thimerosal was included on the agenda for a meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). "Presentation regarding thimerosal in vaccines" was listed as an agenda item for Thursday, June 26, followed by "Proposed recommendations regarding thimerosal-containing influenza vaccine." Thimerosal (also spelled thiomersal) is a mercury‑based preservative that has been used in multi-dose vaccines and medications since the 1930s as a means of preventing contamination, according to the CDC. CDC REMOVES COVID VACCINE RECOMMENDATION FOR HEALTHY CHILDREN AND PREGNANT WOMEN The ingredient is intended to prevent contamination by stopping the growth of bacteria and fungi, the same source states. Due to growing concerns about potential mercury exposure, the American Academy of Pediatrics, Public Health Service agencies and vaccine manufacturers agreed that thimerosal should be "reduced or eliminated in vaccines." In 2001, thimerosal was removed from all vaccines recommended for children 6 and younger — except for influenza. Today, multi-dose flu vaccines still contain thimerosal, but other versions are available without the ingredient. CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER At the June 27 meeting, the CDC's Advisory Committee on Immunization Practices voted to recommend that all adults (including pregnant women) and all children 18 years and younger should receive seasonal influenza vaccines only in single-dose formulations that do not contain thimerosal, according to meeting notes published by the CDC. Despite these recommendations, the CDC and other health agencies have claimed there is no evidence that thimerosal poses health risks. "Thimerosal use in medical products has a record of being very safe," the agency's website states. "Data from many studies show no evidence of harm caused by the low doses of thimerosal in vaccines." CLICK HERE TO GET THE FOX NEWS APP Dr. Jacob Glanville, CEO of Centivax, a San Francisco biotechnology company, reiterated that American children have not been receiving thimerosal for over 20 years in their vaccines, but that it remains in some multi-use vial vaccines, mostly outside the U.S. "We support any effort to remove it entirely — there are other preservatives that are not based on mercury," Glanville told Fox News Digital. For more Health articles, visit Glanville noted that his company's vaccines never contain mercury, aluminum, formaldehyde, or pig- or cow-derived materials. Print Close URL

Is Thimerosal in Flu Shots Safe? Experts Discuss CDC Vaccine Decision
Is Thimerosal in Flu Shots Safe? Experts Discuss CDC Vaccine Decision

Health Line

time12 hours ago

  • Health
  • Health Line

Is Thimerosal in Flu Shots Safe? Experts Discuss CDC Vaccine Decision

A CDC advisory panel voted 5–1 to recommend only flu vaccines without the preservative thimerosal. Thimerosal is a mercury-containing compound used as a preservative in vaccines and other drugs. Doctors and physician advocacy groups warn that the decision could lead to more confusion and vaccine hesitancy. A CDC advisory committee voted 5-1 on Thursday to recommend only single-dose formulations of flu shots that do not contain the preservative thimerosal. The vote follows a shakeup of the Advisory Committee on Immunization Practices (ACIP), in which Health Secretary Robert F. Kennedy Jr. dismissed all 17 members of the panel and hand-picked their replacements. The ouster and subsequent ACIP vote have caused alarm among doctors and physician advocacy organizations—including the American Medical Association (AMA) and the American Academy of Pediatrics (AAP) — who claim the committee is stoking confusion and distrust in vaccines. 'It further undermines vaccine confidence. And they're doing this despite a massive amount of data that confirms that thimerosal is a safe and effective preservative,' said Jake Scott, MD, clinical associate professor of infectious diseases at Stanford Medicine. Thimerosal, a mercury-containing preservative, has been used since the 1930s in vaccines and other drugs. Since the 1990s, it has been the target of intense speculation and debate due to claims — now debunked — that linked it to autism and neurotoxicity. ACIP's new recommendations contradict numerous studies and decades' worth of data showing no link between thimerosal and autism or other neurological conditions. 'This decision does not appear to be data-driven at all,' said Saahir Khan, MD, PhD, an infectious disease specialist with Keck Medicine of USC. 'This will sow a lot of distrust and probably lead to reduced vaccine uptake rates because they are sending a message that indirectly says that we don't think vaccines with thimerosal are safe, whereas the evidence shows that they are safe,' Khan said. What is thimerosal? Thimerosal, which contains about 50% mercury by weight, is one of the most widely used preservatives in vaccines. Every time a drug vial is pierced, it is susceptible to bacterial and fungal contamination. Thimerosal prevents microbial growth and contamination. Today, the use of thimerosal-containing vaccines has declined due to the advent of single-dose vaccine formulations. All routinely recommended vaccines for U.S. children ages 6 and younger are available in formulations without thimerosal. The vast majority of flu shots administered last flu season, about 96%, were also free of thimerosal. ACIP's recommendation this week against thimerosal-containing flu shots applies only to vaccines packaged in multi-dose vials. While multi-dose vials make up only a small subset of flu shots, the format is important for public health. 'Multi-dose vials are cheaper, easier to deploy, and essential for equitable access. They're especially important during pandemics. They proved to be essential during the H1N1 pandemic when single-dose supplies run out a lot faster,' said Scott. Following a review in 1999, conducted as part of the FDA Modernization Act (FDAMA), the FDA, National Institutes of Health (NIH), CDC, and others recommended that thimerosal be removed from childhood vaccines as a precautionary measure. That recommendation was based on 'scientific uncertainty' at the time and sought to reduce total mercury exposure in infants. That review found ' no evidence of harm ' caused by thimerosal in vaccines beyond localized reactions. However, it noted that some infants' cumulative mercury exposure in their first six months exceeded EPA recommendations, and that removing thimerosal could reduce this overall exposure. At vaccine concentrations, thimerosal delivers roughly 25 micrograms of mercury per 0.5 mL dose — about the same amount found in a three-ounce can of tuna. However, there's also an important distinction between the mercury found in thimerosal and tuna. Certain kinds of fish contain methylmercury, which can be toxic. Thimerosal contains ethylmercury, which, in contrast, is eliminated far more rapidly from the body and thus is far less likely to persist and cause harm. Revisiting the thimerosal controversy In the lead-up to this week's vote, Lyn Redwood, a retired nurse practitioner and president emeritus of Children's Health Defense — a group formerly chaired by Robert F. Kennedy Jr., whose mission is 'ending childhood health epidemics by eliminating toxic exposures' — reiterated many claims against thimerosal in an ACIP presentation. However, those claims — especially the alleged link between thimerosal and neurotoxicity — have been extensively debunked. 'There have been multiple well-controlled studies, randomized meta-analyses, and trials comparing vaccines with thimerosal to vaccines without thimerosal to see if there was any difference in neurological outcomes, and these trials generally did not find any connection between thimerosal at the doses used in vaccines and neurological conditions,' said Khan. An often-cited Danish study that included over half a million children found no causal relationship between thimerosal and the development of autism. Another large study of more than 100,000 children in the United Kingdom also found no evidence to support a link between thimerosal and neurodevelopmental disorders. A 2010 study found that exposure to thimerosal in prenatal or infant stages did not increase the risk for autism spectrum disorder (ASD). Perhaps most telling, Scott points out, is that even after thimerosal has been removed from vaccines, autism rates continued to rise. Such was the case for Denmark, which removed thimerosal in 1991, and the United States in 2003. Doctors warn that ACIP's recommendation fails to consider these studies and the large body of evidence supporting vaccine safety. And that will inevitably have consequences for the health of Americans. 'Our studies show that vaccines are safe and effective. I recommend them based on my medical experience, but some people are going to refuse. And unfortunately, they're going to put themselves at higher risk of infection and they're going to put the people around them at higher risk of infection,' said Khan.

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