MOMi Study Seeks to Increase Inclusion of Pregnant and Lactating Individuals in Research

The COVID-19 pandemic systematically highlighted the substantial knowledge gap caused by the lack of inclusion of pregnant and lactating individuals in research.

When questions arose about the safety of COVID-19 vaccine for these individuals during the early stages of vaccine rollout, health officials had little data to go by at first because many of the vaccine trials excluded both groups. This opened the door for misunderstanding and misinformation to spread.

"When you don’t include pregnant and lactating people in trials and there aren’t data about these individuals, then people start filling it in with information that is not true or saying that they weren’t included for a reason," says Andrea Edlow, MD, MSc.

Edlow, a physician-investigator in the Department of Obstetrics & Gynecology at Massachusetts General Hospital, and colleagues from the Ragon Institute of MGH, Harvard and MIT, and UPenn sprang into action to learn more about these questions from a basic science and clinical perspective.

Their efforts resulted in approximately 30 research papers examining maternal and fetal immune response to the COVID-19 vaccine and detailing how antibodies are transferred from mother to baby through the placenta and via breast milk.

The success of that work showed it was possible to thoroughly—and safely—conduct research in pregnant and lactating individuals. It also opened up the door for future research efforts in these previously understudied groups.

With their new Maternal ‘Omics to Maximize Immunity (MOMi) study, Edlow and colleagues are now hoping to further close the knowledge gap by gathering as much information as they can about the maternal-fetal immune system throughout pregnancy and lactation.

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