LOS ANGELES, CALIFORNIA, USA, August 9, 2021 – Maternal health startup Pregistry announced today the start of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER), designed to identify the risk of common obstetric, neonatal, and infant outcomes among pregnant women around the world who received the COVID-19 vaccine. Pregistry is an emerging leader in developing and executing post-approval studies to assess the safety of medications and vaccines used during pregnancy and lactation.
C-VIPER is led by principal investigator Dr. Diego Wyszynski, a renowned perinatal epidemiologist and the CEO of Pregistry. This international, non-interventional study, which launched worldwide on June 01, 2021, collects prospective information from volunteer participants that have been vaccinated during pregnancy or within 30 days before the first day of their last menstrual period. The study population includes two cohorts of pregnant women 18 years of age and older matched by country and gestational age.
Dr. Diego Wyszynski, principal investigator of C-VIPER, and Pregistry CEO recently commented about playing a critical role in one of the most innovative modern vaccination efforts on the planet: “The opportunity to launch a study that has such a deep impact on the global health of pregnant women and children is a defining moment, and Pregistry was founded for this very reason. We look forward to not only delivering vaccination data but also fostering a global pregnancy community for women worldwide.”
The total duration of the C-VIPER study will be five years. Obstetric, neonatal, and infant outcomes will be assessed on an ongoing basis as data becomes available. The first two years will consist of, primarily, enrollment of pregnancies, the third and fourth years will involve follow-up of pregnancies and newborns, and the final year will be dedicated to completing data analyses and publications. Results on pregnancy and neonatal outcomes, even preliminary, are expected within the first year of the study. Quarterly interim reports including pregnancy, neonatal and infant outcomes will be submitted to the Scientific Advisory Committee (SAC) and regulatory agencies for their review and feedback.
Dr. Wyszynski received his medical degree from the University of Buenos Aires and his Masters and Ph.D. degrees in Epidemiology from the Johns Hopkins University School of Public Health. Dr. Wyszynski then spent three years as a postdoctoral fellow at the National Institutes of Health. The Chair of the C-VIPER Scientific Advisory Committee is Dr. Sonia Hernandez-Diaz, a Boston-based Professor of Epidemiology and the Director of the Pharmacoepidemiology Program at one of the top schools of public health in the world.
Pregistry’s mission is to empower women and healthcare providers with the information they need to have healthy pregnancies and healthy babies. As an independent academic organization, Pregistry seeks to help create a world where all women and their health care providers have access to high-quality data about the reproductive and lactation risks of medicines and vaccines. Access to data enables medical practitioners to make informed prescribing choices, which result in the best possible health outcomes for mothers and their babies.
Results of the C-VIPER study will be published periodically on the Pregistry website and in peer-reviewed medical journals. The external Scientific Advisory Committee guarantees that all data is free of external influence, transparent, and of the highest scientific rigor. A final report will be prepared at the end of the study.
Learn more about the study at c-viper.pregistry.com.
About the C-VIPER
The C-VIPER is conducted by Pregistry and includes an internal Safety Management Team (SMT) of experienced pharmacovigilance professionals and a dysmorphologist that meets regularly to review individual cases and safety signals. Additionally, the C-VIPER is in consultation with experts from relevant fields, such as maternal-fetal medicine, infectious diseases, reproductive toxicology, epidemiology, and biostatistics from academic institutions and private practice. These individuals constitute the SAC and provide an independent review of the C-VIPER data. Pharmaceutical and non-pharmaceutical companies are invited to sponsor the C-VIPER.
Pregistry is an emerging global leader in the development and execution of observational studies to assess the safety of medications and vaccines when used during pregnancy and lactation. With over 40 pregnancy specialists, covering a range of clinical, preclinical, safety, regulatory, marketing, and IT needs, the focus is on making sure that both mother and baby are healthy and safe and that prescribers have the information needed to be able to explain the potential benefits and risks of medications during pregnancy and lactation. Pregistry also offers pregnant women a safe space to connect with a global community of experts and peers at no cost. To learn more, please visit: https://www.pregistry.com.
Diego Wyszynski, MD, MHS, Ph.D
Founder & Chief Executive Officer
The C-VIPER study is an online-based study to assess the safety of COVID-19 vaccines in pregnant mothers and their babies.