ROCHESTER, N.Y. (WROC) — Researchers at the University of Rochester Medical Center will study the effects of the COVID-19 vaccine on pregnant women.
The study seeks to determine whether women who get the COVID-19 vaccine during or shortly after pregnancy can pass immunity to their babies in the womb or via breastmilk after birth.
The trial, which is sponsored by the National Institutes of Health, will enroll 2,000 pregnant or breastfeeding women across the U.S. as well as their babies. That will include 135 women from the Rochester area: 100 who were recently vaccinated or plan to be vaccinated while pregnant, and 35 who were or will be vaccinated shortly after giving birth. Women will not be vaccinated through the trial, but should plan to get their COVID vaccinations through community clinics.
Women who participate in the trial will have up to six study visits and their babies will have up to four visits over the course of one year. Some visits will take place in the clinic, while others may be done at participants’ homes. Blood will be collected several times from mothers and their babies and mothers can elect to donate two or three breast milk samples over the course of the study. For women who were vaccinated during pregnancy, the study team will also collect umbilical cord blood when their child is born.
“In addition to being compensated for participating, moms will also find out if their babies are protected from COVID through the study,” said Courtney Olson-Chen, M.D., assistant professor of Obstetrics and Gynecology at URMC. “After a challenging year, that is one bonus of the trial that will hopefully offer a little peace of mind.”
Doctors at URMC say that many OB physicians are currently recommending pregnant women be vaccinated.
“Unfortunately, pregnant women are often excluded from original trials,” Dr. Olsen-Chen said. “So in the original COVID-19 vaccine trials pregnant women were not included. But we really need the information to be able to safely administer these vaccines to this high-risk group.”
The URMC study team, which also includes Cynthia M. Rand, M.D., MPH, associate professor of Pediatrics at URMC, will look for protective antibodies in blood and breastmilk samples from the moms and blood samples from the babies. The level and types of antibodies will tell the team how well moms are protected and whether they passed any protection onto their babies. Moms will also track any vaccine side effects they experience as well as any COVID symptoms they or their babies develop during the study using a smartphone app.
URMC hopes to begin the trial in June. More information can be found here.