US Health Secretary Kennedy's vaccine panel backs preservative-free flu shot
US Health Secretary Robert Kennedy Jr's vaccine advisory panel has recommended Americans receive seasonal influenza shots that are free from thimerosal.
Thimerosal is only used in multi-dose vials of flu shots in the US during the 2024-25 flu season, despite decades of studies showing no related safety issues.
Fewer than 5 per cent of the flu shots administered were from such vials, according to the US Food and Drug Administration (FDA).
Anti-vaccine groups have linked thimerosal to autism and other neurodevelopmental disorders for decades.
Mr Kennedy wrote a book in 2014 in which he advocated for "the immediate removal of mercury" from vaccines. In recent days, he has posted on X about its alleged dangers.
On its website, the FDA said: "There was no evidence that thimerosal in vaccines was dangerous."
The decision to remove it previously was a precautionary measure to decrease overall exposure to mercury among young infants, it added.
Multi-dose forms of CSL's CSL.AX Afluria and Flucelvax as well as Sanofi's SASY.PA Fluzone use thimerosal as a preservative, according to the FDA's website.
Paris-headquartered Sanofi said it would have sufficient supply of its flu vaccine to support customer preference for this season. CSL said it supplies a very low number of multi-dose vials of flu vaccine in response to demand.
The Centers for Disease Control and Prevention (CDC) staff concluded in a report that evidence did not support an association between thimerosal-containing vaccines and autism or other neurodevelopmental disorders.
The report was briefly published and then removed from the meeting's online document site.
Panel member Dr Robert Malone said the directive to remove the staff report came from Mr Kennedy's office.
The panel, called the Advisory Committee on Immunization Practices (ACIP), voted 5-1 in three separate votes to recommend thimerosal-free shots.
The now seven-person panel was installed by Mr Kennedy earlier this month after he fired all 17 previous ACIP outside experts.
The panel advises the CDC on who should take specific vaccines and related products and when they should be given after FDA approval.
It typically meets three times a year and intends to conduct its next meeting in the third quarter, the centres say.
"The risk from influenza is so much greater than the nonexistent — as far as we know — risk from thimerosal," Dr Cody Meissner, the only panel member who voted against the recommendation, said in explaining his vote.
Lyn Redwood, formerly of the Kennedy-founded anti-vaccine group Children's Health Defense, gave the presentation on thimerosal, arguing that it was a neurotoxin.
Ms Redwood's presentation posted on the CDC's website earlier this week initially included a reference to a study that does not exist.
The report she presented to the committee was significantly shorter, removing a slide that made a reference to that study and another 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 Mr Kennedy's changes to vaccine policy.
She said it is unprecedented to have an outside speaker present and then move immediately to a vote.
Evidence is usually compiled formally by the CDC and reviewed by a work group, Dr Havers said.
She added that CDC experts did not present their data publicly to refute Ms Redwood.
CBS and The New York Times have reported that the agency hired Dr Redwood to work in its vaccine safety office.
On Thursday, the committee voted 5-2 to recommend use of Merck's MRK.N recently approved RSV antibody drug Enflonsia for infants eight months or younger whose mothers did not receive a preventive shot during pregnancy.
ACIP panel member Retsef Levi raised safety concerns about the antibody drug, which were addressed by experts at the FDA and CDC.
He said he would be concerned about giving the product to one of his healthy children and was one of the two votes against the recommendation.
The panel's recommendations need to be adopted by either the CDC director or the Health and Human Services Secretary before becoming final.
There is currently no CDC director.
US President Donald Trump's nominee for the post, Susan Monarez, spoke to a Senate committee yesterday as part of the confirmation process.
ABC/Reuters
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Mr Kennedy claimed in a Wall Street Journal op-ed that the ousted panel was 'plagued with persistent conflicts of interest' and had become 'little more than a rubber stamp for any vaccine'. 'Today we are prioritising the restoration of public trust above any specific pro- or anti-vaccine agenda,' he said in a HHS press release announcing the decision. 'The public must know that unbiased science — evaluated through a transparent process and insulated from conflicts of interest — guides the recommendations of our health agencies.' Mr Kennedy subsequently appointed eight new members to the panel, all of whom were ideological allies and prominent vaccine critics. They include Dr Robert Malone, an early researcher of mRNA technology who vocally opposed the Covid vaccines, and Dr Martin Kulldorff, a Swedish epidemiologist and biostatistician who criticised lockdown and social distancing policies, co-authoring the October 2020 'Great Barrington Declaration' with Oxford professor Dr Sunetra Gupta and Stanford professor Dr Jay Bhattacharya, who is now the director of the National Institutes of Health (NIH). This week's regular two-day ACIP meeting, which had been set to vote on the safety of flu vaccines and discuss proposed recommendations for the use of the combined MMRV vaccine for children under five, was updated to include a presentation on thimerosal by Lyn Redwood, a nurse practitioner and former president of Children's Health Defense, the anti-vaccination group founded by Mr Kennedy. Prior to the meeting, a slide contained in the presentation purporting to show thimerosal can have 'long-term consequences in the brain' was discovered to reference a non-existent study. Thimerosal, which is used in about 5 per cent of multi-dose flu vaccines, is a mercury-based preservative that has been in use for decades. It contains ethylmercury, which is cleared from the human body more quickly than methylmercury — the type of mercury found in certain kinds of fish that can be toxic to people at high exposure levels — and is therefore less likely to cause any harm. 'There is no evidence of harm caused by the low doses of thimerosal in vaccines, except for minor reactions like redness and swelling at the injection site,' a fact sheet on the CDC website states. 'In July 1999, the Public Health Service agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines as a precautionary measure.' Dr Kulldorf, the new ACIP chair, said after Ms Redwood's presentation that mercury toxicity was a 'cumulative issue' and 'we should try to minimise exposure'. 'Let's say a child is exposed to mercury from 10 different sources,' he said. 'Each of those 10 sources might be small enough, that source in itself is not dangerous, but if you then put all 10 together then it might be dangerous.' Secondly, he noted 'there are alternatives, and in fact most of the influenza vaccines given today do not contain thimerosal, so it's very feasible to not use thimerosal-containing vaccines … we don't really need it'. Dr Kulldorf added that 'if we put mercury in a product people are not going to want to buy' it. 'So if we want to promote people taking vaccines we should remove these mercury-containing preservatives,' he said. Dr Meissner said he was 'not quite sure how to respond to this presentation'. 'This is an old issue that has been addressed in the past,' he said. 'Of all the issues I think ACIP needs to focus on, this is not a big issue. I will also hasten to add that thimerosal is included in most vaccines that are administered around the globe. 'That is because single-dose vials are more expensive and many countries cannot afford a single-dose vial. I realise ACIP is focused on the United States, but the recommendations that the 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.' Dr Meissner stressed 'it's important to note that no study has ever indicated any harm from thimerosal'. 'It's been used in vaccines since before World War II,' he said. 'The decision by the FDA to remove thimerosal as much as possible is a very reasonable recommendation, but this recommendation was made not because there was any evidence of harm from thimerosal. It was made in an effort to reduce the total exposure to mercury in our environment. That's a reasonable objective. But you also have to consider what are the consequences of these sorts of recommendations.' Dr Joseph Hibbeln, a psychiatrist and neuroscientist with the National Institutes of Health (NIH), noted there was 'a significant benefit to the use of multi-dose vaccines instead of single-dose vaccines'. 'And apparently there is good data that other preservatives can be used, so I hope that the committee will put on the agenda the consideration of multi-use vials … that have other, better preservatives,' he said. Dr Jason Goldman, president of the American College of Physicians (ACP), asked during the public comment section 'if we will have an actual scientific presentation with peer-reviewed literature, strong evidence to actually discuss this issue'. 'Many statements have been made here today without support of science or evidence but merely opinion,' he 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 or will we have layperson presentations only?' Responding to the criticisms, Dr Kulldorf said 'I think it's inappropriate to dismiss a presentation just because the person does not have a PhD or an MD'. 'There are a lot of knowledgeable people who we would like to hear from,' he said. Prior to the meeting, the panel was reduced to seven members with the withdrawal of Dr Michael Ross. HHS said in a statement Dr Ross withdrew 'during the financial holdings review required of members before they can start work on the committee', without providing further details. Dr Ross was described as a clinical professor of obstetrics and gynaecology at George Washington University and Virginia Commonwealth University, but US media reports suggested he had not worked at either school in years. More recently he was linked to private biotech and healthcare ventures.
