Several leading medical organisations have filed a lawsuit against US health Secretary Robert F Kennedy (RFK) Jr and the US Department of Health and Human Services (HHS) over recent changes to the national immunisation schedule and vaccine panel experts at the US Centers for Disease Control and Prevention (CDC).
Among the organisations suing RFK Jr and the HHS include the American Academy of Pediatrics (AAP), Infectious Diseases Society of America (IDSA), Society for Maternal-Fetal Medicine (SMFM), and a pregnant physician.
According to the lawsuit, the groups said that RFK Jr has an agenda to “dismantle the longstanding, Congressionally authorised, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans”.
The lawsuit marks the first legal challenge posited to RFK Jr and the HHS since he remodelled vaccine regulation in the US.
The HHS did not immediately respond to Pharmaceutical Technology when asked for comment.
One of RFK Jr’s first significant policy changes was halting the recommendation of Covid-19 vaccines for healthy children and pregnant women. The health secretary said that no clinical data supports their use in children, whilst claiming – with no evidence – that they are unsafe in pregnant women.
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By GlobalDataThe lawsuit reads: “This is not a hypothetical concern, but a pressing public health emergency that demands immediate legal action and correction.”
The suing organisations said that the recommendation adjustment “immediately exposes these vulnerable populations”. They are also seeking to block RFK Jr’s rollback of Covid vaccine recommendations and pronounce the changes as unlawful.
While RFK Jr is a known vaccine sceptic, Covid-19 jabs have been particularly prevalent in the health secretary’s regulatory crosshairs. Earlier this year, the FDA said it would restrict booster doses in older adults and those at risk of severe illness. Manufacturers of the vaccines will also need to put their products through lengthy placebo-controlled trials before approval, under new guidance.
The medical groups also pointed to sweeping changes made on the CDC’s Advisory Committee for Immunization Practices (ACIP), the committee responsible for reviewing vaccine data and issuing official government recommendations on immunisations. RFK Jr axed all 17 previous members and replaced them with well-known vaccine sceptics and individuals who lack public health expertise.
RFK Jr has also blocked CDC communications, cancelled vaccine panel meetings at the FDA and CDC without explanation, and initiated investigations into links between vaccines and autism.
The lawsuit accused RFK Jr of demonstrating “a clear pattern of hostility toward” established scientific processes and a disregard for expert opinion.
Public health experts interviewed by Pharmaceutical Technology said that the ACIP changes make for a ‘dangerous’ vaccine future in the US.
Richard Hughes IV, partner at Epstein Becker Green and lead counsel for the plaintiffs in the lawsuit, said: “This administration is an existential threat to vaccination in America, and those in charge are only just getting started. If left unchecked, Secretary Kennedy will accomplish his goal of ridding the United States of vaccines, which would unleash a wave of preventable harm on our nation’s children.”
“The professional associations for paediatricians, internal medicine physicians, infectious disease physicians, high-risk pregnancy physicians, and public health professionals will not stand idly by as our system of prevention is dismantled. This ends now.”
The US is battling a measles outbreak this year, with the highest number of annual cases recorded in 33 years. There have been three confirmed deaths from the disease, all in unvaccinated children. RFK Jr has alternated between endorsing and shunning the MMR vaccine, which is proven to provide strong immunity against the disease.
“The ongoing outbreak we are seeing in the US underscores the importance of maintaining adequate levels of measles vaccination,” says International Vaccine Access Center (IVAC) executive director William Moss, who co-leads the measles tracking project.
“The US is at risk of losing its measles elimination status should cases continue at this rate. As vaccine confidence continues to be undermined, immunisation is more important than ever to end this outbreak and prevent future outbreaks from occurring.”
