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Large U.S. COVID-19 vaccine trials will exclude pregnant women for now


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. Moderna (MRNA.O) and Pfizer (PFE.N), which has partnered with Germany’s BioNTech (22UAy.F), 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. Drugmakers say they first need to make sure the vaccines are safe and effective more generally. In addition, U.S. regulators require that drugmakers conduct safety studies in pregnant animals before the vaccines are tested in pregnant women to ensure they don’t harm the fetus or lead to miscarriage.

Reuters UK - July 31, 2020

View the full story here: https://uk.reuters.com/article/us-health-coronavirus-vaccines-pregnancy/large-u-s-covid-19-vaccine-trials-will-exclude-pregnant-women-for-now-idUKKCN24W1NZ