Pregnant women’s inclusion in studies urged
As Washington spends billions of dollars to fast-track a coronavirus vaccine, a number of medical researchers and Democrats are calling on Congress to guarantee that pregnant women are involved in federally supported trials — an inclusion that’s not guaranteed, although research shows they could be particularly vulnerable to the disease.
Of the six pharma companies with government contracts to develop a vaccine, four — Pfizer, Johnson & Johnson, AstraZeneca and Novavax — haven’t included or don’t plan to include pregnant women in their early- or midstage (Phase 1 and 2) trials according to records published by the U.S. National Library of Medicine.
Moderna announced Tuesday that it’s excluding pregnant women from late-stage, “Phase 3” trials.
The sixth company, Merck & Co., has not begun clinical trials and has not decided whether to include pregnant women.
New data from the Centers for
Disease Control and Prevention suggest that pregnant women who contract COVID-19, the disease caused by the coronavirus, appear to have a 50 percent greater chance of entering intensive hospital care because of the virus and a 70 percent greater chance of being put on a ventilator.
The CDC data is preliminary, but “it emphasizes even more the importance of ensuring that pregnant women can get a vaccine,” said Sonja Rasmussen, a professor of pediatrics and epidemiology at the University of Florida who worked at the CDC for 20 years. “That means it has to be studied in them.”
But experts still are debating when and how to do that safely.
In an op-ed published in the medical journal JAMA, public health researchers from Harvard,
Johns Hopkins and Georgetown argued that vaccines should be studied in pregnant women “as soon as feasible after vaccine safety is established,” potentially after Phase 3 trials.
Other researchers argued that pregnant women should be considered earlier — and that some more advanced vaccine candidates, like Moderna’s, already should be including them.
Pregnant women aren’t typically included in major vaccine trials, in part because of concerns that the women and their fetuses might be at heightened risk of complications.
As new data emerge, the calculus could change, said Ruth Faden, a bioethicist at Johns Hopkins University who focuses on immunizations.
For instance, if there’s more evidence linking pregnancy to COVID-19 complications, that would strengthen an argument for testing pregnant women earlier.
“The only way to get vaccines that pregnant women can comfortably take is by gathering evidence during the research and development process,” Faden said.