Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience.
Pharmacoepidemiol Drug Saf
; 23(5): 456-65, 2014 May.
Article
em En
| MEDLINE
| ID: mdl-24644078
ABSTRACT
PURPOSE:
To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine Cervarix®, GlaxoSmithKline, Belgium).METHODS:
We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008-2010).RESULTS:
Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain-Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 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.CONCLUSION:
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 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit-risk profile in adolescent girls and women.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Adjuvantes Imunológicos
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Infecções por Papillomavirus
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Vacinas contra Papillomavirus
Tipo de estudo:
Screening_studies
Limite:
Adolescent
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Adult
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Female
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Humans
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Pregnancy
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article