{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T15:46:10Z","timestamp":1791301570661,"version":"4.1.0"},"reference-count":39,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,2,20]],"date-time":"2014-02-20T00:00:00Z","timestamp":1392854400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2014,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>\n                      To summarise post\u2010licensure safety surveillance over more than 4\u2009years of routine use of the human papillomavirus\u201016\/18\u2010AS04\u2010adjuvanted vaccine (HPV\u201016\/18 vaccine:\n                      <jats:italic>Cervarix<\/jats:italic>\n                      \u00ae, GlaxoSmithKline, Belgium).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We describe global post\u2010licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2\u2010year national immunisation programme in the UK (school years 2008\u20132010).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV\u201016\/18 vaccination. No patterns or trends were observed for potential immune\u2010mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain\u2013Barr\u00e9 syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV\u201016\/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4\u2009years of post\u2010licensure experience may provide confidence to providers and the public about the safety profile of HPV\u201016\/18 vaccine in routine use. The safety profile appears to be consistent with pre\u2010licensure data reporting that HPV\u201016\/18 vaccine has an acceptable benefit\u2013risk profile in adolescent girls and women. \u00a9 2014 The Authors.\n                      <jats:italic>Pharmacoepidemiology and Drug Safety<\/jats:italic>\n                      published by John Wiley &amp; Sons, Ltd.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.3593","type":"journal-article","created":{"date-parts":[[2014,2,20]],"date-time":"2014-02-20T12:47:28Z","timestamp":1392900448000},"page":"456-465","source":"Crossref","is-referenced-by-count":68,"title":["Post\u2010licensure safety surveillance for human papillomavirus\u201016\/18\u2010AS04\u2010adjuvanted vaccine: more than 4\u2009years of experience"],"prefix":"10.1002","volume":"23","author":[{"given":"Maria\u2010Genalin","family":"Angelo","sequence":"first","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Zima","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernanda","family":"Tavares Da Silva","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence","family":"Baril","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felix","family":"Arellano","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Vaccines  Wavre Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,2,20]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40264-013-0039-5"},{"key":"e_1_2_8_3_1","unstructured":"Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization.2012.http:\/\/www.meddramsso.com\/(accessed 21 November 2012)."},{"key":"e_1_2_8_4_1","doi-asserted-by":"crossref","unstructured":"Report of CIOMS Working Group IV.Benefit\u2013risk balance for marketed drugs: evaluating safety signals.1998.http:\/\/www.cioms.ch\/publications\/g4\u2010benefit\u2010risk.pdf(accessed 21 November 2012).","DOI":"10.1515\/ci.1999.21.2.48b"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2008.09.049"},{"key":"e_1_2_8_6_1","unstructured":"Cervarix Summary of Product Characteristics.2012.http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/000721\/human_med_000694.jsp&mid=WC0b01ac058001d124(accessed 21 November 2012)."},{"key":"e_1_2_8_7_1","unstructured":"AngeloM\u2010G DavidM\u2010P ZimaJ et al.Pooled analysis of large and long\u2010term safety data from the human papillomavirus (HPV)\u201016\/18\u2010AS04\u2010adjuvanted vaccine clinical trial programme(in press)."},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050314"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/009286159903300333"},{"key":"e_1_2_8_10_1","unstructured":"Medicines and Healthcare products Regulatory Agency (MHRA).Public assessment report. 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