COVID-19 Vaccine Research: Pregnant Women Must Not Be Left Behind

The frantic race to develop COVID-19 vaccines has been the greatest global scientific and economic effort in history. Research centres, pharmaceutical companies and governments around the world have worked against the clock to develop—in a question of months—vaccines with the highest possible level of safety.

Current evidence indicates that pregnant women are at higher risk for complications and mortality from COVID-19 than their non-pregnant counterparts. The infection also appears to affect the unborn child: pregnant women with COVID-19 have a higher risk of preterm delivery and their babies are three times more likely to be admitted to hospital than those born to mothers not affected by COVID-19.

The question is why, if COVID-19 threatens maternal and perinatal health, have pregnant women not been included in research plans? Once again, these vulnerable groups—women and infants—have been excluded. Several researchers from ISGlobal and the Manhiça Health Research Centre (CISM), among other institutions, have just published a comment in The Lancet about the urgent need for a global research plan for maternal immunisation against COVID-19.

The fact that pregnant women have been excluded from early COVID-19 vaccine research represents a missed opportunity to generate information on the efficacy and, more importantly, the safety of vaccine candidates, an omission affecting the millions of pregnant women and newborn babies who could benefit from these vaccines.

The question is why, if COVID-19 threatens maternal and perinatal health, have pregnant women not been included in research plans? Once again, these vulnerable groups—women and infants—have been excluded

Specific safety and efficacy data on COVID-19 vaccines in pregnant women must be available to enable both mothers and the health care professionals to make an informed decision about vaccination. COVID-19 vaccine studies in pregnant women should be designed to achieve a clear understanding of the risks of COVID-19 in this population and of the safety profile of successful vaccine candidates.

Equity is another important aspect that must not be left out of the equation: the majority (90%) of the more than 213 million pregnancies that occur every year worldwide occur in low-resource settings, where there is a higher risk of complications for the pregnancy and the health of the newborn child.

To provide fair and equitable opportunities for all pregnant women and their infants and to maximise the impact of COVID-19 vaccines worldwide, it is essential that women be included in COVID-19 vaccine research plans.

For more information:

Azucena Bardají, Esperança Sevene, Clare Cutland, Clara Menéndez, Saad B Omer, Teresa Aguado, Flor M Muñoz. The need for a global COVID-19 maternal immunisation research plan (Comment). The Lancet. 25 January 2021. doi.org/10.1016/S0140-6736(21)00146-X.