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The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations

Author

Listed:
  • Diego F. Wyszynski

    (Pregistry)

  • Mondira Bhattacharya
  • Oscar Martínez-Pérez

    (Puerta de Hierro University Hospital of Majadahonda)

  • Anthony R. Scialli

    (Reproductive Toxicology Center, A Non-Profit Foundation)

  • Melissa Tassinari
  • Naor Bar-Zeev

    (Johns Hopkins Bloomberg School of Public Health)

  • Cheryl Renz
  • Sonia Hernández-Díaz

    (Harvard T.H. Chan School of Public Health)

Abstract

Introduction The advent of the coronavirus disease 2019 (COVID-19) pandemic has led to the development of vaccines against severe acute respiratory syndrome coronavirus 2. Prospective evidence regarding safety for pregnant people and their developing fetuses is lacking. The aim of the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) is to estimate the relative risk of obstetric, neonatal, and infant outcomes by comparing participants vaccinated against COVID-19 during pregnancy to a reference group of people enrolled in the Pregistry International Pregnancy Exposure Registry (PIPER) who remained unvaccinated during pregnancy. Methods The C-VIPER and the PIPER are international, non-interventional, real-world cohort studies. Participants receiving a COVID-19 vaccine during pregnancy will be matched in the analyses by country and gestational age at enrollment to unvaccinated individuals. Self-enrolled and self-consented participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after the delivery of a live infant. Where possible, outcomes are verified by medical records. The study aims to recruit at least 500 pregnancies for each approved or authorized vaccine and will last for 5 years for each product. Conclusions By collecting data for each vaccine brand, the C-VIPER will be able to determine individual safety profiles. The study design allows for analysis of the effects of exposure to COVID-19 vaccines during specific etiologically relevant periods of gestation. Although the sample size may be too small to detect associations with rare outcomes, the study will be used to generate hypotheses for future research. Ultimately, the C-VIPER should provide data that will allow pregnant people and their healthcare providers to make informed decisions about COVID-19 vaccination. Clinical Trial Registration ClinicalTrials.gov NCT04705116. Registered on 12 January, 2021. EU PAS EUPAS39096. Registered on 20 January, 2021.

Suggested Citation

  • Diego F. Wyszynski & Mondira Bhattacharya & Oscar Martínez-Pérez & Anthony R. Scialli & Melissa Tassinari & Naor Bar-Zeev & Cheryl Renz & Sonia Hernández-Díaz, 2023. "The COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER): Protocol and Methodological Considerations," Drug Safety, Springer, vol. 46(3), pages 297-308, March.
    • Handle: RePEc:spr:drugsa:v:46:y:2023:i:3:d:10.1007_s40264-022-01271-3
    DOI: 10.1007/s40264-022-01271-3
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    References listed on IDEAS

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    1. Steven T. Bird & Kate Gelperin & Lockwood Taylor & Leyla Sahin & Hoda Hammad & Susan E. Andrade & Mohamed A. Mohamoud & Sengwee Toh & Christian Hampp, 2018. "Enrollment and Retention in 34 United States Pregnancy Registries Contrasted with the Manufacturer’s Capture of Spontaneous Reports for Exposed Pregnancies," Drug Safety, Springer, vol. 41(1), pages 87-94, January.
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    Cited by:

    1. Vincent Bauchau & Kourtney Davis & Sarah Frise & Corinne Jouquelet-Royer & Jamie Wilkins, 2023. "Real-World Monitoring of COVID-19 Vaccines: An Industry Expert View on the Successes, Challenges, and Future Opportunities," Drug Safety, Springer, vol. 46(4), pages 327-333, April.

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