FDA: COVID-19 vaccine choice in pregnancy is personal

Yahoo

3 days ago

Federal health officials have pulled back a key recommendation that pregnant women get the COVID-19 vaccine -- causing sharp criticism from doctors and other experts.
The announcement came Tuesday from Health and Human Services Secretary Robert F. Kennedy Jr., who said the government will no longer recommend COVID shots for healthy children or pregnant women.
Dr. Marty Makary, head of the U.S. Food and Drug Administration (FDA), said Wednesday that the decision should be made between a pregnant woman and her doctor.
"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."
The U.S. Centers for Disease Control and Prevention (CDC) usually relies on a panel of vaccine experts to review studies and make public health recommendations. This process was skipped in making the COVID recommendation.
The CDC, which currently has no director, still hasn't updated its website to reflect the change.
Its advice plays a major role in insurance coverage. If the CDC no longer recommends a vaccine, many patients may be unable to get it for free.
The CDC has said pregnant women are more likely to become seriously sick from COVID than people who aren't pregnant.
Dr. Beverly Gray, an OB-GYN at Duke Health in Durham, N.C., told NBC News she'll keep recommending the shot to her patients.
"The evidence is [overwhelmingly] clear that it reduces the risk of miscarriage, risk of ICU admissions, risk of death," Gray said. "And as an obstetrician-gynecologist who cared for patients through the COVID pandemic and who cared for patients who lost their pregnancies, there are really scary consequences of getting an infection."
She said this sudden change may cause more confusion for pregnant people trying to make informed decisions.
"It's really heartbreaking to see this movement against science and data," Gray said.
Dr. Jesse Goodman, a former FDA chief scientist, said he hasn't seen any "mixed" data about the COVID shot in pregnancy.
"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 told NBC News. "Several studies have also shown that maternal immunization helps protect against illness and hospitalizations in infants less than 6 months old."
Dr. Paul Offit, head of the Vaccine Education Center at Children's Hospital of Philadelphia, agreed.
He said pregnant women are 1.5 to 2 times more likely to be hospitalized or die from COVID.
"It seems to be that the burden of proof on not recommending for pregnancy is on [the government] to prove that it really isn't a value anymore," Offit said.
Tuesday's announcement was made without anyone from the CDC present.
Makary said "many scientists" were involved in the discussions but didn't confirm if any were from the CDC.
He also wouldn't say whether the government would release any data supporting the recommendation.
The American College of Obstetricians and Gynecologists (ACOG) called the move "extremely disappointing," NBC News reported.
"We also understand that despite the change in recommendations from HHS, the science has not changed," the group said in a statement. "It is very clear that COVID infection during pregnancy can be catastrophic and lead to major disability."
More information
The U.S. Centers for Disease Control and Prevention has more on COVID-19 vaccination.
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