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 is not guaranteed though research shows they could be particularly vulnerable to the coronavirus.
Of the six pharma companies with government contracts to develop a vaccine, four — Pfizer, Johnson & Johnson, AstraZeneca and Novavax — have not included or do not plan to include pregnant women in their early- or mid-stage (Phase 1 and 2) trials according to records published by the U.S. National Library of Medicine. Moderna announced Tuesday that it is 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, a spokesperson said.
The federal Food and Drug Administration typically recommends drugmakers include pregnant women once they reach larger Phase 3 trials, some of which are set to launch later this summer. For coronavirus specifically, the agency has advised that vaccine makers at least consider including pregnant women in their trials.
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