An influential American medical journal is rejecting a call from Health Secretary Robert F Kennedy Jr to retract a large Danish study that found that aluminium ingredients in vaccines do not increase health risks for children, the journal’s editor told Reuters.
Kennedy has long promoted doubts about vaccines’ safety and efficacy, and as Health Secretary, has upended the federal government’s process for recommending immunisation.
He has recently been considering whether to initiate a review of shots that contain aluminium, which he says are linked to autoimmune diseases and allergies.
The study, which was funded by the Danish Government and published in July in the Annals of Internal Medicine, analysed nationwide registry data for more than 1.2m children over more than two decades.
It did not find evidence that exposure to aluminium in vaccines had caused an increased risk for autoimmune, atopic or allergic, or neurodevelopmental disorders.
The work is by far the best available evidence on the question of the safety of aluminium in vaccines, said Adam Finn, a childhood vaccination expert in the UK and paediatrician at the University of Bristol, who was not involved in the study.
“It’s solid, a massive dataset and high-quality data,” he said.
Kennedy described the research as “a deceitful propaganda stunt by the pharmaceutical industry”, and said the scientists who authored it had “meticulously designed it not to find harm”, in a detailed 1 August opinion piece on TrialSite News, an independent website focused on clinical research.
He called on the journal to “immediately retract” the study.
“I see no reason for retraction,” said Dr Christine Laine, editor-in-chief of the Annals and a Professor of Medicine at Thomas Jefferson University, in an interview.
The journal plans to respond to criticism the article has received on its website, Laine said, but it does not intend to respond directly to Kennedy’s piece, which was not submitted to the Annals.
The lead author of the study, Anders Peter Hviid, Head of the Epidemiology research department at the Statens Serum Institut in Denmark, defended the work in a response post to TrialSite. He wrote that none of the critiques put forward by Kennedy was substantive and he categorically denied any deceit as implied by the secretary.
“I am used to controversy around vaccine safety studies – especially those that relate to autism, but I have not been targeted by a political figurehead in this way before,” Hviid told Reuters.
“I have confidence in our work and in our ability to reply to the critiques of our study.”
Kennedy had a number of critiques, including the lack of a control group, that the study deliberately excluded different groups of children to avoid showing a link between aluminium and childhood health conditions – including those with the highest levels of exposure – and that it did not include the raw data.
Hviid responded to the criticisms on TrialSite. He said some of the points were related to study design choices that were reasonable to discuss but refuted others, including that the study was designed not to find a link. In fact, he said, its design was based on a study led by Matthew Daley, a paediatrician at Kaiser Permanente Colorado, which did show a link, and which Kennedy cited in his article.
There was no control group because in Denmark, only 2% of children are unvaccinated, which is too small for meaningful comparison, Hviid added. The data are available for researchers to analyse, but individual-level data are not released under Danish law, he said.
Other prominent vaccine sceptics, including those at the anti-vaccine organisation Kennedy previously ran, Children’s Health Defence, have similarly criticised the study on the Annals site.
TrialSite staff defended the study for its scale, data transparency and funding while acknowledging the limitations of its design, a view seconded by some outside scientists.
Laine said that while some of the issues Kennedy raised in his article may underscore acceptable limitations of the study, “they do not invalidate what they found, and there’s no evidence of scientific misconduct”.
An HHS spokesman said the department had “no further comment than what the secretary said”.
See more from MedicalBrief archives:
Aluminium in vaccines no effect on paediatric diseases – Danish study
Why CDC’s vaccine-autism study is raising eyebrows
UK hospitals withdraw surgical device over aluminium exposure fears