A new life-saving vaccine was delivered to 56,000 people in the Congo, but pregnant and breastfeeding women were excluded. Photo: Fiston Mahamba/Zuma Press/PA Images

Imagine you are living in the middle of a deadly disease outbreak. The health authorities rapidly implement a vaccination programme to immunise those most at risk of exposure to the virus. You line up with others from your neighbourhood, but when your turn comes there is a problem: you are pregnant, and the vaccine hasn’t been tested for these circumstances. You are turned away.

This is the situation for women right now in the Democratic Republic of Congo, where the second-most severe Ebola outbreak in history has already claimed more than 300 lives. A new life-saving vaccine has been delivered to 56,000 people in the worst-affected areas, but pregnant and breastfeeding women are excluded from the programme. In DRC, almost two-thirds of people who contracted the virus have died, according to the World Health Organisation, and women are already at greater risk of infection due in part to their social role as caregivers.

Although the situation is particularly acute during epidemics, it is not unique. The same problem arises for many other vaccines, medicines and therapies. These treatments are not necessarily unsafe for pregnant women or their fetuses, but because they haven’t been included during the research and development stages, nobody really knows. Some studies have suggested that so little is known about the safety of using most medicines while pregnant, that women and their doctors are constantly left taking risks in deciding whether or not to use them. This remains true in higher-income countries where the products are often developed before being distributed globally.

“Pregnant women are nearly categorically excluded from biomedical research science,” explained Carleigh Krubiner, one of the lead authors of a recent report on maternal immunisation. And “because we lack the evidence by not including them in research, ultimately we have significant delays or outright denials [in] offering vaccines.”

While the tendency has been to err on the side of caution and recommend against providing treatments to pregnant women, the risks of leaving them untreated can be just as severe—as the case of Ebola highlights.

Historically, women and children often weren’t included in clinical research in an effort to protect them from the potential risks. But that meant there was little evidence base to support their…

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