The first two COVID-19 vaccines to enter large-scale U.S. trials will not be tested in pregnant women this year, raising questions about how this vulnerable population will be protected from the coronavirus, researchers told Reuters.
), this week separately launched clinical trials that use a new and unproven gene-based technology. Both companies are requiring proof of a negative pregnancy test and a commitment to using birth control from women of childbearing age who enroll.
“It’s a problem because if are not tested in pregnancy, then they may not be available or people may not be comfortable offering them,” said Dr. Denise Jamieson, chief of gynecology and obstetrics for Emory Healthcare in Atlanta. Doctors may want to see even more data for completely new vaccine technologies, such as those used by Moderna and Pfizer, compared with one that has already been used in pregnant women.
J&J’s chief scientific officer, Dr. Paul Stoffels, told Reuters the company has done many years of “extensive” preclinical study with the Ebola vaccine, including on pregnant animals, and “has not see any challenges.” Of course, unplanned pregnancies can happen even when women are using reliable contraception. Based on past experiences in such trials, Gruber said he expects about 1% of women in Pfizer’s Phase 3 trial, or about 150 women, will become pregnant. And those women and their babies will be followed closely.
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