The University of Rochester Medical Center is joining a national clinical trial that will study the safety and effectiveness of the COVID-19 vaccine in pregnant women and their babies.
The trial, sponsored by the National Institutes of Health, will enroll 2,000 pregnant or breastfeeding women across the U.S. as well as their babies — including 135 women from the Rochester area. Of the 135 women, 100 must be recently vaccinated or plan to be vaccinated while pregnant, and 35 should be vaccinated shortly after giving birth.
Dr. Angela Branche, the co-leader of the study, said researchers are looking to see if pregnant women produce antibodies or immune responses that are similar to ones they would produce if they weren't pregnant. Researchers also want to see if there are any side effects during pregnancy and if immunity transfers to the fetus — which Branche said they’re really hoping for the latter.
“When babies are born for the first six months of life, they're not actually able to be vaccinated against many things,” Branche said. “They don't really have a formed immune system. So any sort of protection that they have against diseases, infectious diseases they get from their mom.”
Branche said being able to provide that information to vaccine-hesitant mom-to-be’s would be undeniably beneficial.
URMC obstetrician and gynecologist Dr. Courtney Olson-Chen said it’s difficult to stress the importance of vaccination to her pregnant patients when there’s limited backing from trials.
“We know that COVID-19 infection can be more serious in pregnant women,” said Chen, “Unfortunately, pregnant women are often excluded from original trials.”
Now that the vaccine has proven to be effective within the general population, researchers are now able to examine how they work in high-risk groups, like pregnant women.
Chen said pregnant women are more likely to end-up in the intensive care unit and experience pre-term labor if they contract the coronavirus.
The study will begin in June, and is currently enrolling women. This is an observation trial so participants will not be vaccinated through the trial, but should plan to get their COVID-19 vaccinations through community clinics.
To enroll go to www.bringrocback.com .
