Newswise — HealthPartners Institute researchers have released fresh findings in JAMA Network Open indicating that monovalent COVID-19 booster inoculations given during initial pregnancy (pre-20 weeks' gestation) did not link to miscarriage. These findings expand the knowledge base regarding the safety of COVID-19 booster shots for pregnant individuals.
The team examined data from over 100,000 pregnancies spanning from six to 19 weeks' gestation in eight prominent health systems involved in the Vaccine Safety Datalink (VSD) project. This data was gathered from Nov. 1, 2021, to June 12, 2022. By employing a window of either 28 or 42 days, the researchers concluded that receiving a booster vaccination did not correlate with miscarriage.
"Elevated risks of adverse outcomes are associated with COVID infection during pregnancy, but numerous individuals who are pregnant or considering pregnancy exhibit hesitancy towards receiving a booster dose due to safety concerns. Our findings provide substantial evidence supporting the safety of administering booster vaccinations during early pregnancy," stated Elyse Kharbanda, MD, MPH, senior investigator at HealthPartners Institute and the study's lead author.
More safety data to support COVID-19 vaccination
A distinct study, led by HealthPartners Institute and published in Obstetrics & Gynecology, demonstrated that COVID-19 booster vaccinations administered at any stage of pregnancy did not exhibit a heightened risk of serious acute adverse events.
During that study, the researchers analyzed data from over 80,000 pregnancies that took place between September 23, 2021, and June 30, 2022. They found that receiving a booster vaccination during pregnancy did not elevate the risks of thrombocytopenia, myocarditis, venous thromboembolism, ischemic stroke, or other severe adverse events within either a 21-day or 42-day period following vaccination.
"Consistently, our research affirms the safety of COVID-19 vaccinations during pregnancy," remarked Malini DeSilva, MD, MPH, investigator at HealthPartners Institute and the study's lead author. "Continued surveillance of vaccine outcomes holds significance as it offers reassurance and instills confidence in individuals regarding their vaccination decisions."
The data utilized for both studies originated from HealthPartners and seven additional prominent health systems comprising the Vaccine Safety Datalink (VSD). VSD is a research network funded by the Centers for Disease Control and Prevention (CDC), dedicated to conducting post-marketing surveillance of vaccines licensed and employed within the United States. These studies specifically examined the safety of the monovalent COVID-19 vaccine booster. Subsequent studies will assess the safety of the bivalent booster.
About HealthPartners Institute
HealthPartners Institute is part of HealthPartners, the largest consumer governed nonprofit health care organization in the nation with a mission to improve health and well-being in partnership with our members, patients and the community. HealthPartners Institute supports this mission through research and education—advancing care delivery and public health around the globe. The Institute annually conducts more than 350 research studies and trains 700+ medical residents and fellows and 1,200+ medical and advanced practice students. Its integration with HealthPartners’ hospitals, clinics and health plan strengthens the Institute’s ability to discover and develop evidence-based solutions and translate them into practice. Visit healthpartnersinstitute.org for more information.
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