July 15, 2020

The Washington Post: Some researchers and politicians call for pregnant women to be included in coronavirus vaccine testing

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.


Read the full article on the Washington Post website here

By:  Shefali Luthra
Source: The Washington Post