US Secretary of Health and Human Services Robert F. Kennedy jnr. Photo / Getty Images
Health and Human Services Secretary Robert F. Kennedy jnr violated the law and imperilled public health when he withdrew some recommendations about coronavirus vaccines, a coalition of medical associations alleged in a lawsuit filed today.
The lawsuit against Kennedy and other top government health officials seeks to overturn the United States Health Secretary’s decision in May to end the Government’s long-standing blanket recommendation that children and pregnant women should receive the shots.
The reversal has made it difficult for some pregnant women to get vaccinated to protect themselves and their future children, according to the health groups that filed the lawsuit.
Medical professionals rely on - and are sometimes legally bound by - federal vaccine recommendations to decide whom to immunise.
The American Academy of Paediatrics, the American College of Physicians, the Infectious Diseases Society of America, and the Society for Maternal-Foetal Medicine are among the organisations that joined forces to file the lawsuit in federal court in Massachusetts.
Their lawsuit escalates efforts by public health organisations to preserve access to vaccines that are now under scrutiny by Kennedy, who founded an anti-vaccine organisation.
“He’s actively undermining vaccine safety and efficacy and confidence in vaccines by everything he’s done,” said Georges C. Benjamin, the leader of the American Public Health Association, one of the plaintiffs.
In an email, HHS spokesman Andrew Nixon said: “the secretary stands by his CDC reforms”.
HHS has previously defended Kennedy’s rollback of coronavirus vaccine recommendations, arguing that he was “taking urgent action to ensure the public’s safety when it comes to Covid-19 vaccines”.
In response to Kennedy, the Centres for Disease Control and Prevention shifted from recommending the vaccine to healthy children to encouraging parents to consult their doctors.
The agency also stopped offering specific guidance to pregnant women, a decision that medical providers have said caused confusion and limited women’s access to the shots.
The move effectively blocked pharmacists from providing coronavirus vaccines to pregnant women in more than half of the US states, said Brigid Groves, vice-president of professional affairs at the American Pharmacists’ Association, which is not part of the lawsuit.
Under the rules of those states, the authority of pharmacists to offer vaccines is tied to federal immunisation recommendations, she said.
“Their hands are tied,” Groves said.
“Pharmacists are being forced to turn away pregnant patients who want a vaccine we know is safe and could protect them and their babies because the law won’t let them give it.”
In late May, Kennedy posted a 58-second video on X saying the coronavirus vaccine would no longer be recommended for healthy children and pregnant women.
He was flanked by Food and Drug Administration Commissioner Marty Makary and Jay Bhattacharya, head of the National Institutes of Health, who are also named as defendants in the lawsuit.
The unprecedented move bypassed the traditional system for offering vaccine advice to the public and blindsided officials at the CDC, the agency charged with offering such recommendations.
The lawsuit includes an anonymous pregnant physician and says it will be “more difficult” for her to access the coronavirus vaccine.
It asks a judge to set aside Kennedy’s coronavirus vaccine directives and urges the court to order Kennedy to say on X that the vaccine recommendations are restored for pregnant women and children.
It also seeks to immediately prevent the Government from enforcing the new recommendations.
The lawsuit contends that Kennedy “has demonstrated a clear pattern of hostility toward established scientific processes, a disregard for expert guidance, an affinity for placing persons who align with his anti-vaccination views in positions of authority at HHS, and a reliance on bias and pretext to further his apparent agenda: to undermine trust in vaccines and reduce the rate of vaccinations in this country”.
The plaintiffs argue that Kennedy - who has a long history of disparaging vaccination - has undercut vaccines in an “arbitrary” and “capricious” way without following proper federal agency policy, giving them grounds for the lawsuit under the Administrative Procedure Act.
In a May document explaining his decision, Kennedy argued there was not enough data on the benefits of vaccination and the safety of immunisation during pregnancy.
The lawsuit decries Kennedy’s removal of 17 vaccine advisers whom he replaced with eight panel members he named in June. One withdrew before the first meeting “during the financial holdings review” process, according to Nixon, the HHS spokesman.
The lawsuit argues that pregnant women and their infants are at high risk for coronavirus complications, citing evidence presented at a vaccine panel meeting held before Kennedy acted.
After revisions to the recommendations, anecdotal reports have emerged of people hitting roadblocks trying to obtain coronavirus vaccines.
Jaron Goddard, who was pregnant at the time, said she recently called four pharmacies in the Seattle area to determine whether they would offer a coronavirus vaccine in the autumn. Each one told her they would not offer the coronavirus vaccine to someone who is pregnant. Some cited the CDC’s revised guidance, she said.
In one instance, Goddard asked if a note from her obstetrician would make a difference, but a pharmacist told her it would not, she said. Goddard, a 36-year-old lawyer, said she later had a miscarriage.
The lawsuit comes amid other changes to coronavirus vaccination policy that have alarmed public health experts.
Earlier this year, top FDA officials unveiled plans to narrow agency approval for updated coronavirus vaccines to adults aged 65 and older and others at high risk of severe disease.
The US has been an outlier in continuing to broadly recommend updated coronavirus vaccines. Now that the vast majority of Americans have some immunity, most people’s defences are trained to fight the virus.
But some public health experts have said it makes sense to continue broadly recommending vaccines because some people may not know they have a condition that places them at high risk. Vaccination is designed to reduce the risk of severe outcomes.