COVID-19 vaccine trials leave out pregnant women, children


Almost all of the many clinical trials underway to establish the safety of potential COVID-19 vaccines are not open to pregnant women or children, which means public health experts may not have vaccine safety and efficacy data for these populations when it comes time to vaccinate them.

Trials begin testing in healthy adults, as this population provides a baseline view of the immune response caused by an experimental vaccine and has the lowest risk of experiencing side effects. However, this population is not entirely representative of the demographics or health characteristics of a country.

This lack of representation is potentially problematic, as many women of childbearing age work on the front lines of healthcare facilities, and these employees will likely be among the first to receive a vaccine granted with emergency use authorization. Additionally, there is likely to be a significant push to inoculate children once a vaccine becomes available so schools can operate safely.

Drugmakers with COVID-19 vaccine trials in progress have not yet included pregnant women or women who are breastfeeding in their testing. AstraZeneca is the only drugmaker with plans to supply the U.S. that has begun to test its vaccine in children.

"I think that there's a recognition that if we don't have a vaccine that we can reasonably offer for safe use in pregnancy, then we're going to have a real problem in terms of covering the populations that we know we need to cover," bioethicist Carleigh Krubiner, PhD, told STAT. "There is certainly a plausible scenario where we have an emergency use authorization [for a vaccine] or a licensed product where there is not any robust data on the product in pregnancy."


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