As the world awaits a vaccine to help build immunity and reduce the spread of SARS-CoV-2, some researchers question whether or not the vaccine will be effective in pregnant women and their infants.

“The major issue in my field of pediatrics and maternal and child health is that we often cannot study the effectiveness of vaccines and other therapies because pregnant women and children are oftentimes left out of these clinical studies,” said Cheryl Gale, MD, FAAP, an associate professor in the Department of Pediatrics in the University of Minnesota Medical School.

Dr. Gale began thinking about ways to benefit these mothers and their infants — both through developing effective treatments for COVID-19 until a vaccine is available and through gathering pertinent data that may inform that vaccine’s development. She applied for a CO:VID (Collaborative Outcomes: Visionary Innovation & Discovery) grant to kick-start her research, which focuses on some of the body’s tiniest co-habitants — bacterial microbes.

“We have microbes, or microorganisms, on our skin, in our gut, everywhere. They co-exist with us and can cause disease but can also be beneficial for our health,” said Dr. Gale who leads another study on how breast milk microbes play a role in forming an infant’s metabolism and risk for diseases like diabetes or obesity. “We know that the microbes in our gut are also important for how we develop immunity, and in thinking about COVID-19 then, I wondered if the microbes in our gut might be influencing how our immune systems react to SARS-CoV-2.”

Her research seeks to understand if an association exists between normal microbiomes, or communities of microorganisms, and better health outcomes for pregnant women and their infants with a SARS-CoV-2 infection or COVID-19. To do this, Dr. Gale has teamed up with the U of M’s Clinical and Translational Science Institute to build a database of pregnant women and their infants affected by SARS-CoV-2 using patient records available through the M Health Fairview partnership.

“And then, we’re going to be reaching out to these families after the infant is at one month and six months of age to collect additional information from them about infections and other information about their interim health,” Dr. Gale said.

The most relevant clinical factors to this research include the ones that affect the microbes in the gut. Dr. Gale says these factors include whether or not mothers or infants received antibiotics or if they were exclusively breastfeeding, feeding strictly with formula or giving infants a mixture of both. Even the mode of birth, either through C-section or vaginal delivery, could play a role in health outcomes related to COVID-19 due to its effects on the microbiome.

“Using statistical models, we want to look at those factors that are known to affect early life microbiomes and see if any are associated with health outcomes,” Dr. Gale said. “For example, do babies that are born vaginally and are all breastfed, if their moms had COVID-19, are they less likely to get COVID-19 during their postnatal period? Or, in the cases of the mothers, if they were on antibiotics during the latter part of their pregnancy, while they were positive for COVID-19, did they have more severe symptoms of COVID-19, maybe because their microbiomes were being disrupted?”

If there are associations, Dr. Gale says finding them will inform future clinical studies that could lead to better treatments for pregnant women and their infants — for example, could you give probiotics to these patients to help change their gut bacteria and improve their outcomes? 

But beyond finding new treatments, Dr. Gale’s database, which she hopes will be ready for analysis in early 2021, will also be part of a national perinatal registry developed by the American Academy of Pediatrics Section on Neonatal Perinatal Medicine and the University of Florida that may inform the development of prevention strategies, including an effective vaccine.

“This database, which will show how women and children are being affected by the virus, will give us a baseline of information that will help researchers better understand, if we do develop vaccines and we do test them in pregnant women and children, do they actually decrease or prevent symptoms and disease due to COVID-19?” Dr. Gale explained. “The more numbers you have, the more robust your research results can be, and that’s why the Medical School’s collaboration with this national registry is so important.”