NPR

Protect Pregnant Women 'Through Research,' Not 'From Research,' OB-GYNs Urge

As COVID-19 vaccines roll out, doctors say it's long past time to address the exclusion of pregnant women from research on drugs and vaccines. They say better study design is the answer.
According to a review published in 2018, nearly 75% of the drugs approved by the Food and Drug Administration in the 21st century had no data associated with their use during pregnancy.

Doctors who treat pregnant patients are finding themselves in a tough and familiar spot as the COVID-19 vaccines roll out: making decisions about the use of a particular medicine in this group of patients without any clinical evidence to guide them.

"We've been denied that evidence," says Dr. Judette Louis, chair of obstetrics and gynecology at the University of South Florida. While it has been headline news that the COVID-19 vaccines haven't yet been tested in pregnant people, the problem is broader. "There are very few vaccines that have," Louis says.

During a in December, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the nation's top infectious disease expert, said that testing for safety and immunogenicity of the COVID-19 vaccines in pregnant women and young children had not yet begun but are in the works. "Those studies will probably start

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