Influenza vaccine(Seqirus GmbH)

After hearing a presentation alleging the dangers of thimerosal-containing vaccines — dismissed by the president of the American College of Physicians as "merely opinion" — and input from about a dozen other medical organisations and paediatricians affirming the preservative's safety and the vaccines' necessity to save lives, a majority of the Centers for Disease Control and Prevention's (CDC's) vaccine committee voted to discontinue the use of flu shots with that ingredient. The vote comes after Health and Human Services Secretary Robert F. Kennedy Jr. abruptly fired the former 17 members of the Advisory Committee on Immunization Practices (ACIP) and hand-picked eight new members. One of those appointees, however, withdrew from ACIP right before the first day of the meeting due to financial conflicts.Of the seven remaining members, five voted in favour of recommending that children 18 years and younger, pregnant women and all adults receive seasonal flu vaccines only in single-dose formulations that are free of thimerosal as a preservative. Vicky Pebsworth — who has served on the board of the National Vaccine Information Center, a group known to share vaccine misinformation — abstained from voting. "I think we should not be using thimerosal as a preservative," she later said, clarifying that her abstention was due to how the voting question was worded.One ACIP member voted against limiting flu vaccinations to only those without thimerosal: Cody Meissner, a paediatrics professor at the Dartmouth Geisel School of Medicine and the former chief of paediatric infectious diseases at Tufts Children’s Hospital.At the end of the meeting, he explained that his dissenting vote was due to a concern that "by insisting the multi-dose vials contain thimerosal, that might limit the availability of the influenza vaccine for some people." Meissner added that "the risk from influenza is so much greater than the non-existent, as far as we know, risk from thimerosal. So I would hate for a person not to receive the influenza vaccine because the only available preparation contains thimerosal. I find that very hard to justify."All members except Pebsworth, who again abstained, voted to recommend routine annual influenza vaccinations in all individuals 6 months and older who do not have contraindications.Meeting material mishapsThe vote on thimerosal-containing vaccines was a last-minute addition to ACIP's agenda. The preservative contains ethylmercury, a type of mercury that is rapidly cleared from the body and is distinct from the potentially toxic variant of methylmercury. Vaccine sceptics, including Kennedy, have claimed that thimerosal is linked to autism and other neurological disorders, though a wide body of evidence — including the CDC's own studies — has debunked the autism claim and found that thimerosal in vaccines is safe. No jabs on the childhood vaccination schedule contain thimerosal, and only three multi-dose flu shots with the preservative — Seqirus' Afluria and Flucelvax, and Sanofi's Fluzone — are approved for use in the US. Thursday's meeting featured a presentation on thimerosal from Lyn Redwood, a nurse practitioner who previously served as president of the anti-vaccine group Children's Health Defense, which was founded by Kennedy. A report from Reuters found that an early version of Redwood's presentation posted to the CDC's website contained a citation for a study on thimerosal's long-term consequences in the brain that did not actually exist. The citation was removed from her slides before Thursday's meeting.That wasn't the only late adjustment to meeting materials, however. Multiple commenters also decried the removal of a CDC report that had concluded there is no evidence to support a connection between thimerosal-containing vaccines and autism."My understanding is that article was not authorised by the office of the secretary and has been removed," ACIP member Robert Malone said in response to a request that the CDC document be reposted online.'Cumulative exposure'The argument amongst ACIP members who voted to no longer provide thimerosal-containing flu shots was that while one dose may be safe, "cumulative exposure" to the preservative could be harmful. "We cannot completely avoid exposure to mercury, but it's a cumulative issue," ACIP chair Martin Kulldorff said. "The amount available in the vaccine, maybe that amount is safe. But…we are exposed to mercury from other sources. So it's cumulative." Kulldorff used to be a professor of medicine and epidemiology at Harvard Medical School. Malone added that because the discussion centred on seasonal flu jabs, "for those unfortunate few receiving doses from a multi-dose vial…we do have a risk of repeated exposure to this. So it's not just a one-time administration, but a potential chronic exposure through [one's] lifetime on an annual basis." ACIP member Retsef Levi, a professor of operations management at the MIT Sloan School of Management, said it was the committee's responsibility to "control the controllable sources of exposure" to mercury. "If you start looking one by one at each specific exposure, you might conclude, 'Okay, nothing wrong with that.' But if you try enough times and in a cumulative way, you might have some harm. And in this case, it's clear you have harm. So that's not debatable based on my understanding of the evidence," Levi said. Safety a settled issueWhen it was Meissner's turn to comment on thimerosal-containing vaccines, however, he appeared baffled. "I'm not quite sure how to respond to this presentation. This is an old issue that has been addressed in the past," he said, reiterating the difference between ethylmercury and methylmercury. Meissner also pointed out the potentially dangerous precedent ACIP might be setting for global vaccine policies."I realise ACIP is focused on the United States, but the recommendations that ACIP makes are followed among many countries around the world, and removing thimerosal from all vaccines that are used in other countries, for example, is going to reduce access to these vaccines. It will increase cost," he said. "And I think it's important to note that no study has ever indicated any harm from thimerosal."Representatives from several medical associations that commented during the meeting — the National Association of County and City Health Officials (NACCHO), the American College of Obstetricians and Gynecologists (ACOG), the American College of Physicians (ACP) and the American Pharmacists Association (APhA) — all backed up Meissner's assertion of thimerosal's safety or questioned the data within Redwood's presentation.Matt Zorn, the liaison for NACCHO, remarked that not only is there no evidence of harm from jabs with the preservative, "but it's really worth emphasising that that is based on a 25-year robust history of studies that examined the real-life outcomes for children who have received thimerosal-containing vaccines, either in the prenatal or the paediatric period.""As a physician, as a public health practitioner, I'm very confident that thimerosal-containing vaccines are safe," he added.ACOG representative Naima Joseph concurred. "We are comfortable with the overwhelming data that show that prenatal exposure has not been linked to any autism spectrum disorders," she said. "That data is concrete." ACP President Jason Goldman and APhA liaison Jean-Venable "Kelly" Goode both used their comment periods to take issue with the claims made in Redwood's presentation."I am wondering if we will have an actual scientific presentation with peer-reviewed literature, strong evidence to actually discuss this issue, as many statements have been made here today without support of science or evidence…The established data for decades really speaks to the safety and efficacy of thimerosal," Goldman said. "Will there be an actual CDC presentation done by staff, scientists, physicians and those who are subject matter experts with accurate, peer-reviewed scientific data for the ability for the committee to review? Or will we have layperson presentations only?"Kulldorff scolded Goldman and Goode for their remarks, saying Redwood "is very knowledgeable about vaccines…I think it's inappropriate to dismiss a presentation just because the person does not have a PhD or an MD."Coverage concernsWhile the ripple effect of Tuesday's vote could be felt globally, its impact in the US will be minimal for now. Less than 5% of seasonal flu vaccine doses given during the 2024-2025 season were from multi-dose, thimerosal-containing vials, an FDA spokesperson said. However, several speakers during the public comment session raised concerns about how the ACIP's votes on Thursday and at future meetings could affect insurance coverage of vaccines. "ACIP recommendations do not require anyone to get vaccinated, but they do provide the certainty of insurance coverage, which is critical in allowing Americans to access vaccines. In eliminating recommendations, you are threatening coverage and essentially removing choice for people who want to get vaccinated to protect their families, themselves and their communities," remarked Millicent Gorham, CEO of the nonprofit Alliance for Women's Health and Prevention. "Competing recommendations will only increase preventable, vaccine-preventable diseases. The risks here are not theoretical. They are painfully real. Children and adults alike will become sick and die from these serious illnesses."

With the eight new members of the Centers for Disease Control and Prevention's (CDC's) vaccine advisory committee set to meet next week, a draft agenda released Wednesday shows some significant departures from — and notable additions to — the list of vaccines the panelists were expected to review and vote on. The new appointees were named by Health and Human Services Secretary Robert F. Kennedy Jr. last week, just two days after he fired all 17 sitting members of the Advisory Committee on Immunization Practices (ACIP). FirstWord is conducting a poll to gauge how US physicians feel about the overhaul (see – Physician Views Preview: Vaccine trust on trial after ACIP upended).The ACIP meeting, originally scheduled for three days, has been shortened to just two: June 25 and 26. Several vaccines that had been slated for discussion have been removed from the agenda, including meningococcal, pneumococcal, cytomegalovirus and lyme disease jabs. A presentation and subsequent vote on childhood and adult HPV vaccines are also absent, which may have Merck & Co. breathing a sigh of relief. Martin Kulldorff, one of the new ACIP appointees, was reportedly an expert witness in multiple lawsuits alleging that the pharma intentionally hid safety risks for its HPV shot Gardasil (see – Vital Signs: Ahead of key deadlines, biopharma shrugs off latest policy portents).ACIP will still review anthrax, chikungunya and COVID-19 vaccines; a vote on the latter's use had been expected, but is not listed on the agenda. Maternal and paediatric respiratory syncytial virus (RSV) vaccines are still scheduled for a discussion and vote, including Merck's newly approved RSV preventative antibody Enflonsia (clesrovimab-cfor). The product, along with Sanofi and AstraZeneca's Beyfortus (nirsevimab-alip), are cleared to protect neonates and infants, but ACIP's recommendation will dictate their usage. For more on the two preventative products, see Spotlight On: Five factors shaping the RSV antibody showdown.New to the agendaThe agenda also featured two new additions. A yet-to-be-determined person will give a presentation on the measles, mumps, rubella and varicella (MMRV) vaccine in children under the age of five years old, and propose recommendations for the jab's use in that age group.  And while flu jabs, part of the original slate of topics, remain on the agenda, the discussion now includes an additional presentation and vote specifically on thimerosal-containing flu vaccines. Similarly, the person giving this new presentation is listed as "TBD."In the absence of a CDC director, Kennedy, who has made non-factual and critical statements in the past about the measles vaccine and thimerosal, is responsible for adopting — or rejecting — any recommendations made by ACIP. Measles historyDuring a recent Senate hearing, Kennedy claimed that the measles vaccine was not tested in a placebo-controlled trial. Sen. Bill Cassidy (R-La) later pointed out that this assertion was not true, and corrected Kennedy. At the same hearing, Sen. Chris Murphy (D-Conn.) questioned Kennedy's support of the measles vaccine, accusing him of "repeatedly undermining the vaccine with information that is contested by public health experts."When pressed by Murphy to say he supports the measles vaccine, Kennedy refused to answer.Kennedy's stance against the measles vaccine dates back at least several years. In 2019, he traveled to Samoa a few months before a measles outbreak that caused 1867 hospitalisations and 83 deaths, mostly in children. Alec Ekeroma, Samoa’s director general of health, told the Guardian in an interview last year that on that visit, Kennedy led a "significant disinformation campaign" stoking distrust in vaccines. Autism link debunkedThimerosal, a preservative added to multi-dose vaccine vials to prevent growth of bacteria and fungi, has also been a long-time target of Kennedy's. Thimerosal contains ethylmercury, a type of mercury that is rapidly cleared from the body and is distinct from the potentially toxic variant of methylmercury. The MMR vaccine, which used to contain thimerosal, was linked to autism in a widely debunked Lancet paper published by Andrew Wakefield in 1998. According to the Children's Hospital of Philadelphia, "the studies were deemed fraudulent and data misrepresented."While the CDC recommended removing thimerosal from vaccines routinely given to infants as a precautionary measure in 1999, multiple studies conducted by the agency have since concluded that there is no association between thimerosal-containing vaccines and an increased risk for autism spectrum disorder. However, Kennedy wrote in a 2005 article — printed by the Rolling Stone and published online by Salon — that thimerosal "appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children." He also claimed "government health agencies colluded with Big Pharma to hide the risks of thimerosal from the public."The story was later removed from Salon's website after "evidence continued to emerge debunking the vaccines and autism link," said Joan Walsh, who was editor-in-chief when the article was published. "But continued revelations of the flaws and even fraud tainting the science behind the connection make taking down the story the right thing to do."It's unclear what will be discussed during the presentation on thimerosal at the ACIP meeting on June 26. According to the FDA, only three approved multi-dose vaccine vials still contain thimerosal: Seqirus' Afluria and Flucelvax, and Sanofi's Fluzone.