HealthPartners Institute receives $2M from CDC to study COVID-19 vaccines and pregnancy, birth outcomes

Working with 8 large health systems and the Centers for Disease Control and Prevention, HealthPartners will design and lead surveillance to help inform COVID-19 vaccine recommendations for pregnant women

BLOOMINGTON, Minn. – HealthPartners Institute has received more than $2 million from the Centers for Disease Control and Prevention to conduct surveillance that will help determine whether the preventive shots have any impact on pregnancy, birth outcomes or infant development.

The projects will involve the eight other large health systems that make up the Vaccine Safety Datalink, a research network that conducts post-marketing surveillance of vaccines licensed and used in the United States. HealthPartners Institute will jointly lead the projects with Yale University researcher physician Heather Lipkind, MD.

“After any vaccine is approved, it’s important to continue monitoring data for associations that were not apparent during clinical trials,” said Elyse Kharbanda, MD, MPH, HealthPartners Institute researcher and principal investigator on the projects. “Comprehensive surveillance is important for ensuring trust in vaccines and vaccine safety.”

While pregnancy has excluded women from being eligible to participate in COVID-19 vaccine research, pregnancy is not a contraindication for the authorized COVID-19 vaccines that are now being rolled out across the globe.

The American College of Obstetricians and Gynecologists recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination. Instead, pregnant women should discuss vaccination with their care providers and consider the rate of COVID-19 transmission in their area. In addition, pregnant women must consider potential vaccine side effects against the growing body of research that shows COVID-19 more severely impacts pregnant women and birth outcomes. A recent study that HealthPartners Institute participated in showed higher rates of stillbirth among pregnant women with the virus.

As part of a 5-year project, Kharbanda and colleagues will analyze health care data from the participating health systems to evaluate the risk of adverse pregnancy and birth outcomes following COVID-19 vaccination in pregnant women. The researchers will also review data to better understand whether vaccines impact the development of infants.

A second 3-year project will similarly analyze health care data to evaluate risk of stillbirth and miscarriage following COVID-19 vaccination in pregnant women.

As part of the Vaccine Safety Datalink, HealthPartners Institute has participated in numerous similar post-marketing surveillance studies for other vaccines and has lead prior studies on pertussis and influenza vaccines in pregnancy. Findings typically are shared with the Advisory Committee for Immunization Practices to guide vaccine recommendations.

Kharbanda added, “Vaccines will be the best way to overcome this pandemic and these projects are part of the process of ensuring the vaccines in-use are effective and safe.”