FDA chief says pregnant women should decide on Covid vaccine with doctors
SILVER SPRING, Md. — The Food and Drug Administration commissioner, Dr. Marty Makary, said Wednesday that the decision of whether a pregnant woman should get a Covid vaccine should come down to a conversation with her doctor — not a recommendation by the federal government.
Makary took part in Health and Human Services Secretary Robert F. Kennedy Jr.’s announcement Tuesday revoking the Centers for Disease Control and Prevention’s recommendation that Covid shots should be offered to pregnant women and healthy children.
“The data on the Covid vaccine booster in pregnant women is a mixed set of data,” Makary said in an interview. “Now, I think the decision should be between a doctor and a pregnant woman, but the idea that the government has to tell you what to do in this in an area where there is mixed data.”
That assertion — that the data is mixed — isn’t supported by evidence, vaccine experts say.
The CDC doesn’t mandate vaccination. For decades its panel of independent vaccine experts, called the Advisory Committee on Immunization Practices, has recommended vaccination for certain groups of people based on data. The panel then passes recommendations to the director of the CDC to endorse. (For example, the CDC advises pregnant women to get an inactivated influenza vaccine during flu season.) The U.S. surgeon general established the committee in 1964.
Tuesday’s decision skipped the usual process of consulting the CDC’s vaccine advisory committee and having the CDC director formally sign off. (The CDC currently has no director.)
The CDC’s recommendation plays a key role in determining which vaccines insurance companies must cover at no cost to patients.
Covid risks during pregnancy
OB-GYNs quickly raised alarms over patient access to the vaccine.
Pregnant women are at increased risk of serious complications from Covid compared with people who aren’t pregnant, according to the CDC.
At the height of the Covid pandemic, doctors reported an unprecedented surge in pregnant women hospitalized and in critical condition after Covid infections.
Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA, said he’s not aware of any “mixed” data on the Covid vaccine in pregnant women.
“I am aware of multiple studies that have shown the benefit of Covid vaccines in protecting pregnant women, who are very clearly at very high risk of more severe outcomes from Covid,” he said. “Several studies have also shown that maternal immunization helps protect against illness and hospitalizations in infants less than 6 months old.”
Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Pennsylvania, said pregnant women are 1½ to two times more likely to be hospitalized and die from Covid infections.
“It seems to be that the burden of proof on not recommending for pregnancy is on you to prove that it really isn’t a value anymore,” said Offit, adding that federal health officials hadn’t provided evidence to end the recommendation.
Goodman added that if there are concerns about a specific study, the FDA should review the data and report on it.
“Let’s give people accurate information and freedom of choice,” he said.
As of Wednesday, the CDC hadn’t updated its website to align with the new recommendations.
Kennedy’s announcement Tuesday — flanked by Makary and the director of the National Institutes of Health, Dr. Jay Bhattacharya — drew attention for what it lacked: CDC officials.
Asked about the people involved in revoking the Covid vaccine recommendation, Makary said “many scientists” were consulted, but he didn’t answer whether any were from the CDC.
“I didn’t organize that discussion, but there were a lot of individual discussions and group discussions, and I was part of those discussions, and I was certainly asked of my opinion,” he said. “The FDA has a very clear role of approving products based on the data presented to the FDA. The CDC has a role of issuing recommendations. And so, this really was a CDC announcement in consultation with many scientists.”
He also declined to say whether the Department of Health and Human Services will make any data about how it arrived at its decision public.
“Well, look, the tradition, the system that we have, is a system whereby Congress gives us a charge as the nation’s top drug regulator, and that is to approve or not approve drugs based on the data presented to the FDA,” Makary said. “So our job has always been to review data that is submitted and then make a decision about it. Now, that data is sometimes made public, the companies make it public. We encourage total transparency of that data. They often make the data public once the drugs are approved.”
The American College of Obstetricians and Gynecologists said it was “extremely disappointed” by Kennedy’s announcement.
“We have seen firsthand how dangerous Covid infection can be during pregnancy and for newborns who depend on maternal antibodies from the vaccine for protection,” it wrote in a statement Tuesday. “We also understand that despite the change in recommendations from HHS, the science has not changed. It is very clear that Covid infection during pregnancy can be catastrophic and lead to major disability.”