{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T18:57:49Z","timestamp":1779217069778,"version":"3.51.4"},"reference-count":41,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T00:00:00Z","timestamp":1777420800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine\u2010derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We descriptively analysed AEFIs to nOPV2 and other vaccines reported to VigiBase from January 1, 2010 to December 31, 2023. Proportional Reporting ratios (PRRs) at Medical Dictionary for Regulatory Activities (MedDRA) higher level group term (HLGT) compared signals of disproportionate reporting (SDR) between nOPV2 and two comparators.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 409\u2009001 AEFIs were included (nOPV2 specific AEFIs: n\u2009=\u200918\u2009911 [4.6%]), of which 54.0% males (n\u2009=\u200910\u2009209) and 22.6% serious (n\u2009=\u20094283). Most events had resolved (n\u2009=\u20099418, 49.8%) or were resolving (n\u2009=\u20096239, 33.0%) at reporting. Body temperature conditions, gastrointestinal and respiratory tract\u2010related events were most reported to nOPV2. Five \u2018novel\u2019, mostly non\u2010serious SDRs were identified \u2010 oral soft tissue conditions (PRR: 2.47, 95% CI: 1.71\u20133.59), haemoglobinopathies (PRR: 31.53, 95% CI: 3.38\u2013312.72), malabsorption conditions (PRR: 4.65, 95% CI: 1.79\u201312.09), neoplasm\u2010related morbidities (PRR: 3.61, 95% CI: 1.44\u20139.11) and skin and subcutaneous tissue infections and infestations NEC (PRR: 3.55, 95% CI: 2.61\u20134.82). Among the serious events, nervous system\u2010related events were reported more.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>nOPV2 appears to retain a positive safety profile in real\u2010world use. We support its continued use for cVDPV outbreak response and advocate continued monitoring as coverage increases and reporting is no longer mandated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70580","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T05:42:28Z","timestamp":1777527748000},"source":"Crossref","is-referenced-by-count":1,"title":["Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase"],"prefix":"10.1002","author":[{"given":"Comfort Kunak","family":"Ogar","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht the Netherlands"},{"name":"Department of Global Health and Manufacturing Services United States Pharmacopeia (USP)  Rockville Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Malede Mequanent","family":"Sisay","sequence":"additional","affiliation":[{"name":"Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Care University Medical Center Utrecht  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5878-5088","authenticated-orcid":false,"given":"Leonardo","family":"Roque\u2010Pereira","sequence":"additional","affiliation":[{"name":"Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Care University Medical Center Utrecht  Utrecht The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Leopold","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7452-0477","authenticated-orcid":false,"given":"Patrick C.","family":"Souverein","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aukje K.","family":"Mantel\u2010Teeuwisse","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9197-7068","authenticated-orcid":false,"given":"Marie L.","family":"De Bruin","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences Utrecht University  Utrecht the Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,4,29]]},"reference":[{"key":"e_1_2_10_2_1","first-page":"1","volume-title":"Implementation of novel Oral polio vaccine type 2 (nOPV2) for circulating vaccine\u2010derived poliovirus type 2 (cVDPV2) outbreak response: technical guidance for countries","author":"World Health Organization","year":"2020"},{"key":"e_1_2_10_3_1","unstructured":"Global Polio Eradication Initiative (GPEI).GPEI\u2010Novel Oral Polio Vaccine type 2 (nOPV2) granted EUL recommendation [Internet].2020[cited 2025 Feb 15]. 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