SILVER SPRING, Md. — The head of the U.S. Food and Drug Administration (FDA), Dr. Marty Makary, said on Wednesday that pregnant women should make their own decision about receiving the COVID-19 vaccine in consultation with their doctors, rather than following a federal government recommendation.
Makary’s comments came after Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday that the federal government was withdrawing the Centers for Disease Control and Prevention’s (CDC) recommendation for COVID-19 vaccination in pregnant women and healthy children.
“The data on the COVID vaccine booster in pregnant women is mixed,” Makary told reporters. “This decision should be between a doctor and a pregnant woman. The government doesn’t need to intervene in an area where the data is not clear.”
However, public health experts dispute that claim. Vaccine researchers say existing data strongly supports COVID-19 vaccination during pregnancy.
The CDC, while it does not mandate vaccines, typically issues recommendations based on advice from an independent panel known as the Advisory Committee on Immunization Practices. The committee reviews scientific data and passes recommendations to the CDC director. The CDC currently recommends that pregnant women receive certain vaccines, including the flu shot. However, Tuesday’s decision bypassed the usual CDC advisory process and was made without a formal endorsement from the CDC director—who has not yet been appointed.
The CDC’s recommendations also help determine which vaccines insurance companies must cover at no cost.
Concerns Over COVID Risks in Pregnancy
Medical groups and OB-GYNs have raised concerns that the move could limit vaccine access for pregnant patients.
According to the CDC, pregnant women face a higher risk of severe illness from COVID-19 compared to non-pregnant individuals. During the height of the pandemic, hospitals reported a sharp increase in pregnant patients requiring intensive care.
Dr. Jesse Goodman, a professor of medicine at Georgetown University and former FDA chief scientist, rejected the idea that the data is unclear.
“I’m not aware of any mixed data,” he said. “There are multiple studies showing that the vaccine protects pregnant women and also offers protection to infants under six months through maternal antibodies.”
Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said pregnant women are 1.5 to 2 times more likely to be hospitalized or die from COVID-19. “If you’re not going to recommend it, you need strong evidence to show it’s no longer beneficial,” he said, adding that no such evidence was provided by federal officials.
Goodman also said that if concerns exist over specific studies, the FDA should review and release the data publicly.
“People deserve accurate information and the freedom to choose,” he said.
Lack of Transparency Criticized
As of Wednesday, the CDC website had not been updated to reflect the change in guidance. Tuesday’s announcement by Kennedy featured Makary and Dr. Jay Bhattacharya, director of the National Institutes of Health, but no CDC officials were present.
Asked whether CDC scientists were consulted, Makary said that “many scientists” had been involved in discussions but did not confirm if any were from the CDC.
“I didn’t organize the discussions, but I participated and shared my opinion,” he said.
Makary also declined to say whether the Department of Health and Human Services would release the data that led to the change. He emphasized the FDA’s role as a regulatory body focused on approving drugs based on data provided by manufacturers, noting that this data is often made public by the companies themselves.
The American College of Obstetricians and Gynecologists strongly criticized the decision.
“We are extremely disappointed,” the group said in a statement. “We have seen firsthand how dangerous COVID infection can be during pregnancy. Despite the change in policy, the science remains the same: COVID infection during pregnancy can cause serious harm.”
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