HPV bivalent vaccine (types 16 and 18)
Cervarix is a vaccine against the two HPV types that cause most cervical cancers. It is no longer sold in the United States, where Gardasil 9 is used, but remains in use in many other countries.
Overview
The bivalent HPV vaccine was authorised in the EU in September 2007 and approved by the FDA in October 2009 for prevention of cervical cancer, cervical intraepithelial neoplasia and adenocarcinoma in situ caused by HPV 16 and 18 in females aged 9 to 25 (10 to 25 in the US), on the PATRICIA phase 3 trial of more than 18,000 women, which showed near-complete protection against type-specific CIN2+ in HPV-naive women and cross-protection against types 31, 33 and 45. GSK withdrew it from the US market in 2016 for commercial reasons; it remains WHO-prequalified and is used in national programmes, including single-dose schedules supported by the KEN SHE trial and the Costa Rica Vaccine Trial follow-up. Injection-site pain and fatigue are the main adverse effects.
Approvals
| Region | Year | Indication |
|---|---|---|
| EU | 2007 | Prevention of premalignant cervical lesions and cervical cancer caused by HPV 16 and 18 from age 9 (Cervarix); anal lesions added later |
| US | 2009 | Prevention of cervical cancer and precursor lesions caused by HPV 16 and 18 in females 10 to 25 (discontinued in the US 2016) |
Trials
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Latest papers
topQuery for this drug: (TITLE:"HPV bivalent vaccine" OR ABSTRACT:"HPV bivalent vaccine" OR TITLE:"types 16 and 18" OR ABSTRACT:"types 16 and 18" OR TITLE:"Cervarix" OR ABSTRACT:"Cervarix") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about HPV bivalent vaccine (types 16 and 18), not a curated reading list.
Pages like this
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- TrialKEN SHE (single-dose HPV vaccine)
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