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.

The ultimate goal of the five-year, $12M study, which is funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID), is to create a Pregnancy Immune Atlas—a publicly available resource for researchers that combines vast troves of data about cell processes, biochemistry, protein production, RNA transcription, immune activity and gene function during pregnancy and lactation.

Focusing on Omics

What sets this research study apart is its focus on omics, Edlow explains. Omics is an umbrella term for a number of different scientific disciplines (genomics, proteomics, metabolomics, etc.) that seek a broad-based understanding of what’s happening in a cell, organ or organism at a particular point of time.

Instead of focusing on the activity of a specific gene or protein activity, omics allows investigators to get a real-time snapshot of what’s happening at a systems level.

“Maternal immunity remains pretty mysterious and understudied, and one of the ways to start learning huge amounts without being biased by what you already know is omics. And then that knowledge is going to drive future hypothesis-driven research,” explain Edlow. “But to start, you take a global survey.”

Looking Ahead: Hopes for the Future of Pregnancy Immunity Research

In addition to Edlow, the MOMi team includes Galit Alter, PhD, and Boris Juelg, MD, PhD, from the Division of Infectious Diseases at Mass General and the Ragon Institute of MGH, Harvard and MIT.  Michal Elovitz, MD, and Rick Bushman, PhD, from the Perelman School of Medicine at the University of Pennsylvania, Doug Lauffenburger, PhD, from MIT, and Alex Shalek, PhD, of MIT, the Broad Institute and the Ragon Institute round out the team.

Each member brings a unique set of skills that will be crucial to collecting, understanding and integrating the vast amounts of data needed to build out the Pregnancy Atlas.

“The only way to tackle some of these big theoretical questions about immunity and pregnancy is with a team that has multiple skill sets,” Edlow explains. “Some of these techniques and ways of looking at data are so specialized that one person can’t do them all.”

Edlow hopes the team’s efforts will open the door for more research and clinical trial opportunities to continue unraveling the mysteries of pregnancy immunity.

“How can we integrate all this knowledge to really get a sense of the whole system, and how does one perturbation—whether it’s having COVID, getting a vaccine in pregnancy, environmental exposures, exposure to bisphenol A or other endocrine-disrupting chemicals—affect that system?”

“We’re not protecting our kids by excluding them from research and we’re not protecting pregnant and lactating individuals by excluding them from research,” Edlow says. “We have to protect them through ethical research.”

“That’s a huge change and an understanding shift that I’d like to see happen in the next five years, and I think grants like this are a big step towards achieving that.”

About the Mass General Research Institute
Research at Massachusetts General Hospital is interwoven through more than 30 different departments, centers and institutes. Our research includes fundamental, lab-based science; clinical trials to test new drugs, devices and diagnostic tools; and community and population-based research to improve health outcomes across populations and eliminate disparities in care.
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