{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T04:18:34Z","timestamp":1793852314460,"version":"4.6.1"},"reference-count":30,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T00:00:00Z","timestamp":1781740800000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Birth Defects Research"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pregnant women are at increased risk of severe illness from COVID\u201019, yet they were excluded from the initial clinical trials of COVID\u201019 vaccines, resulting in limited pregnancy\u2010specific safety data. The COVID\u201019 Vaccines International Pregnancy Exposure Registry (C\u2010VIPER) was established to prospectively collect safety and birth outcome data following COVID\u201019 vaccination during pregnancy. This article summarizes key operational, methodological, and scientific lessons from implementation of the registry.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The C\u2010VIPER was designed as an international, noninterventional, postmarketing cohort study using a web\u2010based platform to enroll pregnant women exposed to COVID\u201019 vaccines and collect longitudinal maternal, pregnancy, birth, neonatal, and infant outcome data. Registry implementation, recruitment, retention, questionnaire design, comparator selection, data completeness, and evolving vaccination patterns were reviewed to identify lessons relevant to future pregnancy safety studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Implementation during a global pandemic presented substantial challenges, including uncertainty regarding vaccine acceptance and study participation among pregnant women, widespread misinformation and vaccine hesitancy, evolving vaccination regimens, recruitment and long\u2010term retention difficulties, and limitations in questionnaire design and data completeness. Despite these challenges, the C\u2010VIPER demonstrated the feasibility of conducting a large\u2010scale multinational, web\u2010based pregnancy registry under emergency conditions and highlighted important methodological considerations for future postmarketing vaccine safety studies in pregnancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The C\u2010VIPER contributed to the broader evidence base evaluating COVID\u201019 vaccination during pregnancy and provided important lessons for the design and implementation of future pregnancy registries. Future studies should prioritize early planning, flexible protocol design, robust recruitment and retention strategies, careful comparator selection, and mechanisms to improve data completeness and quality.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial Registration:<\/jats:bold>\n                      NCT04705116, EUPAS39096.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bdr2.70082","type":"journal-article","created":{"date-parts":[[2026,6,18]],"date-time":"2026-06-18T16:17:18Z","timestamp":1781799438000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Lessons Learned From the\n                    <scp>COVID<\/scp>\n                    \u201019 Vaccines International Pregnancy Exposure Registry: Insights for Designing and Implementing Global Pregnancy Safety Studies"],"prefix":"10.1002","volume":"118","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6293-3429","authenticated-orcid":false,"given":"Diego F.","family":"Wyszynski","sequence":"first","affiliation":[{"name":"Thermo Fisher Scientific Inc.  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheryl","family":"Renz","sequence":"additional","affiliation":[{"name":"Thermo Fisher Scientific Inc.  Waltham Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,18]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-024-01458-w"},{"key":"e_1_2_10_3_1","unstructured":"CIOMS\/WHO.2016.\u201cInternational Ethical Guidelines for Health\u2010Related Research Involving Humans.\u201dhttps:\/\/cioms.ch\/wp\u2010content\/uploads\/2017\/01\/WEB\u2010CIOMS\u2010EthicalGuidelines.pdf."},{"key":"e_1_2_10_4_1","unstructured":"EMA.2017.\u201cGuideline on Good Pharmacovigilance Practices (GVP) Module VIII\u2014Post\u2010Authorisation Safety Studies (Rev 3).\u201dhttps:\/\/www.ema.europa.eu\/en\/documents\/scientific\u2010guideline\/guideline\u2010good\u2010pharmacovigilance\u2010practices\u2010gvp\u2010module\u2010viii\u2010post\u2010authorisation\u2010safety\u2010studies\u2010rev\u20103_en.pdf."},{"key":"e_1_2_10_5_1","unstructured":"European Medicines Agency.2004.\u201cGuideline on 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