New Study Shows mRNA COVID-19 Vaccines Safe for Pregnant People:
C-VIPER Pregnancy Registry Finds No Increased Risk of Spontaneous Abortion
Waltham, MA, March 16, 2023 – CorEvitas, LLC (“CorEvitas”), a leading provider of syndicated registries, is pleased to share important safety information regarding mRNA COVID-19 vaccines and their use in pregnant people.
CorEvitas sponsors the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER), which follows pregnant vaccinated individuals from enrollment until the infant is 12 months of age. Using monthly online self-administered questionnaires, vaccination certificates, and medical records, the study has found that mRNA COVID-19 vaccines do not increase the risk of spontaneous abortion when used in early pregnancy, compared to the risk in the general population. The findings were published in the journal, Pharmacoepidemiology and Drug Safety.
“We believe that this study will help alleviate concerns among pregnant individuals who may be hesitant about getting vaccinated,” said Dr. Diego Wyszynski, CEO of Pregistry, LLC, recently acquired by CorEvitas. “Pregistry is committed to being at the forefront of designing and executing regulatory-required pregnancy exposure registries, including the world’s largest pregnancy registries on COVID-19 vaccines and treatments.”
Dr. Wyszynski’s expertise in the maternal health field is unparalleled, and his recent appointment as Deputy Editor of the journal, Birth Defects Research further cements CorEvitas' position as an expert in this space. Birth Defects Research is the official publication of the Society for Birth Defects Research and Prevention, and Dr. Wyszynski's role allows him to increase the visibility of important research in this field.
The article in Pharmacoepidemiology and Drug Safety can be accessed via this link: http://doi.org/10.1002/pds.5600.
CorEvitas is a science-led, real-world data intelligence company. Using syndicated registry data and analytic services to understand the post-approval comparative effectiveness and safety of approved therapies, CorEvitas provides biopharmaceutical companies with objective data and clinical insights to demonstrate the value of their products to clinicians, patients, payers, and regulators. The company operates nine major autoimmune and inflammatory registries across the U.S., Canada, and Japan, collecting data from over 400 participating investigator sites, including the collection of biosamples linked to deep clinical data. CorEvitas recently expanded its services to include Pregnancy Registries through the acquisition of Pregistry, LLC. CorEvitas also conducts client-sponsored registries through its Patient Powered Registries business, employing a transformative patient-focused registry model to support research needs for patient-centered outcomes across all therapeutic areas. The company’s regulatory-grade registry data is complemented by its Patient Experience business, supporting evidence-based patient engagement initiatives across the product lifecycle, as well as its Specialty EMR Data business and retinal data set. CorEvitas is headquartered in Waltham, MA and is a portfolio company of Audax Private Equity. www.corevitas.com
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