Viewpoint: Here’s why excluding pregnant women from COVID vaccine efficacy and safety trials is misguided

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To date, more than 140 drug treatments and numerous vaccines are being evaluated to treat and prevent Covid-19 infection. Vaccines for pregnant women are one of the most important public health measures undertaken globally to reduce disease. Yet the pregnant population is currently barred from participating in Covid-19 vaccine and treatment trials during the pandemic, which means that the health of pregnant women and their fetuses will be an afterthought.

When pregnant women are excluded from Phase 3 vaccine trials, we aren’t able to collect the safety and immunogenicity data that will inform recommendations on vaccinating and protecting pregnant women. We will not know whether a different dose of the vaccine may be needed in pregnancy to achieve antibody levels high enough to benefit mother and child. This is important information, given that pregnancy has dramatic effects on how almost all drugs are metabolized and excreted.

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In addition, it is not uncommon for lack of knowledge about drugs in pregnancy to lead well-meaning physicians to withhold or delay lifesaving medications from pregnant women out of misplaced fear. This trend was noted during the 2009 H1N1 influenza pandemic with the guarded use of oseltamivir (Tamiflu), and undoubtedly had an adverse impact given that earlier use of this antiviral is linked with improved clinical outcomes.

Pregnant women deserve better.

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