A pregnant physician is at the center of a new lawsuit against Health and Human Services Secretary Robert F. Kennedy Jr., and doctors say her concerns about whether she’ll have access to a COVID-19 vaccine shot reflect a growing confusion about vaccine policy across the country.
The pregnant person — identified in court filings as “Jane Doe” — is one of several plaintiffs in a federal lawsuit filed this week in Massachusetts that features a coalition of medical societies, including those focused on children and pregnant people such as the American Academy of Pediatrics (AAP) and the Society for Maternal-Fetal Medicine (SMFM). Doe herself is a physician.
According to the lawsuit, Doe is more than 20 weeks pregnant and works in a hospital “where she puts herself at risk of infectious diseases every day to care for patients and save lives.”
She was vaccinated against COVID-19 before becoming pregnant, but her doctors advised her to get another dose later in pregnancy for better protection against the disease, according to the lawsuit. While Doe has not yet tried to obtain a COVID-19 vaccine, she intends to while pregnant. She fears she will be unable to because of Kennedy’s recent changes to COVID-19 vaccine policy for pregnant people, according to attorneys for the plaintiffs.
“Her worries are not just for herself, but also for the health and safety of her unborn child,” the lawsuit reads.
The lawsuit focuses on Kennedy’s announcement in May on social media, which plaintiffs describe as a directive, that COVID-19 vaccination would be removed from the recommended vaccine schedule for healthy pregnant people and healthy children. The change was made without consulting vaccine experts or staff from the Centers for Disease Control and Prevention, according to the lawsuit.
Richard Hughes, an attorney with Epstein Becker Green who represents the plaintiffs, said the lawsuit seeks to show Kennedy’s directive was “arbitrary and capricious,” in part because it did not follow the longstanding process for vaccine recommendation changes and it did not include a detailed explanation on the decision. Kennedy also did not cite an emergency or change in circumstances to justify the move. An HHS spokesperson did not immediately respond to a request for comment from the secretary.
It is generally unusual for medical organizations to join together to sue the nation’s top health secretary and other government officials over an administration policy. The lawsuit also includes the American College of Physicians, American Public Health Association, Infectious Diseases Society of America and Massachusetts Public Health Alliance.
“This step is not one we take lightly. It’s not one we ever wanted to take at all, but we can no longer wait for government officials to sort this out,” said Dr. Susan Kressly, president of AAP, during a briefing with reporters. “Pediatricians cannot stay silent as the system we rely on to support lifesaving vaccines is chiseled away piece by piece. With Secretary Kennedy leading efforts to sow doubt and distrust in the American success story of vaccines, we are on [a] dangerous path.”
Kennedy’s COVID announcement caught the medical community by surprise, in part because it contradicted his own health department. Days earlier, the head of the Food and Drug Administration, a division of HHS, drafted an article in The New England Journal of Medicine that said “pregnancy and recent pregnancy” are factors which “increase a person’s risk of severe COVID-19.”
In June, the CDC shared data showing that vaccinations can decrease complications and hospitalizations for both pregnant people and eligible children.
“Peer-reviewed studies have demonstrated that administration of the vaccine during any trimester in pregnancy lowers hospitalization rates, serious illness and adverse outcomes in pregnant people and infants,” said Dr. Sindhu K. Srinivas, president of the Society for Maternal-Fetal Medicine, who also participated in the media briefing. “These studies show no harm to the pregnant patient, the pregnancy or the newborn resulting from administration of the COVID-19 vaccination during pregnancy. The federal directive has no evidentiary basis in obstetrics or infectious disease.”
The CDC later released immunization guidelines that kept COVID-19 vaccination recommendations for children, but noted it should be a decision in consultation with doctors.
The medical community has become increasingly vocal about its concern over the future of vaccine policy in America under Kennedy, a vaccine skeptic. The system has taken decades to build and is tied deeply to evidence-based science, they said.
In June, Kennedy fired all 17 members of an independent panel that makes vaccine recommendations and replaced them with people who lack related experience in microbiology, epidemiology or immunology. That panel, the Advisory Committee on Immunization Practices (ACIP), has since taken some actions that doctors say are politicized, including announcing plans to revisit the childhood vaccine schedule.
The new ACIP members did not vote on COVID-19 vaccines for pregnant people and children during their June meeting — a move that some doctors say has created additional confusion given Kennedy’s directive in May.
Dr. Angela Branche, an infectious disease expert at the University of Rochester Medicine, commented on the potential real-world consequences of ACIP’s lack of COVID-19 votes during a press briefing last month, noting that pharmacies and doctors’ offices may not stock the vaccines or insurance companies may not cover them.
“We are basically operating blind for the coming season as to what to do as clinicians for these two vulnerable populations,” Branche said.
Dorit Rubenstein Reiss, a professor of law at the University of California College of Law, San Francisco, who studies vaccine law and policies, said she is still reviewing the lawsuit. But she said it’s not surprising that a pregnant person would be worried about the availability of COVID vaccines, especially since many access them at pharmacies.
“Pharmacies right now aren’t sure of their liability,” she said.
Kressly with AAP said her organization is hearing from pediatricians all over the country that Kennedy’s directive on COVID-19 vaccines has had a ripple effect, where parents are having “significant concerns about every single vaccine” on the childhood immunization schedule. This comes amid growing cases of measles around the country that have just hit a 30-year high.
Kressly said parents are also concerned that Kennedy’s actions are among the first toward removing additional recommended vaccines for adults and children.
“This is causing uncertainty and anxiety at almost every pediatric visit that involves vaccines, and we vaccinate at well visits as well as any opportunity that the child is in the office. So this has significant impacts, especially as children head back to school and we immunize them over the summer season in preparation for that,” she added.
For now, AAP has been highlighting its plans to continue publishing a separate set of vaccine recommendations. Kressly has suggested that parents talk with their family physicians and pediatricians about vaccines.
Reiss said families should be thinking a lot more about the potential shifting landscape of vaccine availability. That means they should know how their public or private insurance covers vaccines, since such coverage is dictated by ACIP actions.
“In other words, there’s at least a chance that insurance coverage of vaccines will be severely undermined within the near future, as the new committee starts chopping at the existing vaccine recommendations,” she said.
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