Consider pregnancy in COVID-19 therapeutic drug and vaccine trials
14 May, 2020131 million women give birth annually. This population is particularly vulnerable to emerging infectious pathogens due to alterations in immune, respiratory, and cardiovascular physiology that occur during pregnancy. Early data regarding pregnancy outcomes in COVID-19 are reassuring: maternal outcomes are similar to non-pregnant adults, and vertical transmission and neonatal infection are rare.
However, pregnant women remain at risk of severe disease requiring intensive care, and they deserve equity in access to therapeutic options informed by rigorous scientific data.
Pregnant women have systematically been excluded from clinical trials of therapeutics and vaccines. There are currently more than 300 trials exploring therapeutics for COVID-19, yet near universal exclusion of pregnant women, despite many of these trials repurposing drugs already widely, and safely, used in pregnancy.
These drugs are now the subject of clinical trials to assess efficacy and safety in treatment of COVID-19, yet pregnant women are often missing in these trial populations.
The COVID-19 pandemic highlights the vulnerability of sick pregnant women if systematically excluded from clinical trials, and potentially limits their access to therapeutics through off-label or compassionate use. Clinical registries might collect data about exposures but will not allow pregnant women access to evidence-based care informed by clinical trials. Moreover, vaccination in pregnancy protects the mother, fetus, and newborn. This tripling of benefit means rapid vaccine development must allow pregnant women safe and timely inclusion in vaccine trials.