This story is republished from STAT, the health and medicine news site that’s a partner to the Globe. Sign up for STAT’s free Morning Rounds newsletter here.
WASHINGTON — Health secretary Robert F. Kennedy Jr. appointed two new members to the main federal vaccine advisory board, his latest change to a group that has made a series of controversial recommendations and upended the usual processes for vaccine policy.
Both new members of the Advisory Committee on Immunization Practices are OB-GYNs who have at times been critical of mainstream vaccine science. An ACIP working group is reviewing the vaccines recommended for women during pregnancy.
One of the appointees, Kimberly Biss, has questioned the safety and effectiveness of vaccines, despite evidence affirming their use. She has particularly focused on the COVID-19 vaccine’s effects on women, suggesting it has caused widespread infertility and harm during pregnancy. (Multiple independent reviews of getting the COVID vaccine during pregnancy have confirmed its safety and efficacy.)
The other new member is Adam Urato, a maternal-fetal medicine doctor based in Massachusetts. Urato is close with Tracy Beth Høeg, the acting director of the Center for Drug Evaluation and Research at the Food and Drug Administration. Høeg also serves as the FDA representative to ACIP. Urato appears to share the vaccine skepticism that’s become a defining feature of the members of Kennedy’s ACIP, according to his social media posts.
Though the new members are unlikely to dramatically change the balance of the committee, they appear to further set the group on a course that’s skeptical of vaccines. Neither Urato nor Biss immediately responded to a request for comment.
The new appointments to the committee come as Kennedy is remaking the group. He fired the members who served during the Biden administration and replaced them with his own picks. Kennedy’s ACIP has shirked usual processes and made decisions counter to decades of medical and public experts’ consensus.
Still, Kennedy’s most drastic changes to federal vaccine policy came after he sidelined ACIP entirely. Following an executive order from President Trump, health officials unilaterally downgraded their recommendations for several childhood vaccines, making the United States an outlier among peer nations.
Urato has long fought against the medical establishment. He spent years publicly questioning the FDA’s approval of Makena, a drug to prevent preterm births. He noted that the trial data were weak and helped file a citizen’s petition to remove the drug from the market. In 2022, an FDA advisory panel agreed with him, and the following year, the company voluntarily pulled the drug.
“I’ve been involved with this activism and patient protection for my whole career,” Urato told STAT during an interview in early December. “Certainly over the last 20 years.”
Urato has not said as much about vaccines. But he appears to lean more skeptical of vaccination, particularly in pregnant women, according to his X account. “The science is not ‘long-settled’ regarding vaccines,” Urato posted in June. He remarked to the New York Times in 2021 that his patients were worried about the COVID vaccines potentially harming fetal development.
In September 2023, he posted a link to a study looking at COVID-19 vaccine mRNA distribution in breast milk. “We don’t know the risks this poses,” Urato wrote. “Many of my pregnant & breastfeeding patients had concerns re: unknown vaccine effects. Enforcing vaccine mandates on these women was cruel & inhumane.”
He’s spent more time worrying about the potential harms of antidepressant medicines known as SSRIs. It’s a position he shares with Kennedy, who has called the drugs “harder to quit than heroin” and has falsely linked them to mass shootings. In July, Urato was a speaker on an FDA panel organized by Høeg that discussed antidepressant use during pregnancy and was largely composed of people who are skeptical of antidepressants.
Nine medical experts STAT spoke with at the time said that researchers have generally not detected clear, major risks associated with SSRI use during pregnancy, for either mothers or babies, but they have clearly documented the risk of untreated depression, which can kill people. They noted that Urato and others tend to focus on vague risk and overlook the clear benefits of the drugs.
Urato filed a citizen petition with the FDA in September asking the agency to warn SSRI users about potential complications with pregnancy and fetal brain development. Høeg became unusually involved in the petition, agency sources told STAT, presenting slides summarizing the petition to top drug center leaders. She presented the slides as her own, but staff later found in the document’s metadata that the presentation was created by Urato.
Biss has shared a deep distrust of the pharmaceutical and medical establishment.
She is currently a fellow at the Independent Medical Alliance, a Kennedy-aligned group that has cheered new vaccine policy from the Trump administration. She currently practices with Women’s Care, an OB-GYN group in Florida, and she was previously chief of staff at Bayfront Health.
She’s a fellow of the American College of Obstetricians and Gynecologists, which has objected to vaccine policy from the Trump administration and ACIP. (Biss reposted an X post calling for ACOG to be defunded following its criticism of Kennedy.)
Biss appears to already be in alignment with the majority of the current committee. She previously reposted a post on X questioning vaccination for newborns — just weeks after ACIP recommended delaying the hepatitis B vaccine dose usually given to newborns. And she cheered the administration’s remaking of the vaccine schedule by executive order.
She has also broken through in Washington, previously sharing her concerns about alleged dangers of COVID-19 vaccines in testimony before Congress, alongside Robert Malone, who is currently an ACIP member. Biss has pushed for tissue studies to understand alleged harms from mRNA vaccines and has suggested, without evidence, that people fast to reduce the vaccine’s effects.
During the hearing, led by former representative Marjorie Taylor Greene, a Georgia Republican, Biss suggested COVID-19 vaccinations led to increased miscarriage rates, maternal mortality, and infant mortality, among other health issues, which she said caused her “great concern.” She has since said she recommends pregnant women avoid mRNA vaccines.
ACOG recommends that pregnant women receive a COVID shot to protect themselves and their baby. Studies have not shown an association between vaccination and any health issues during pregnancy.
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