# HPV bivalent vaccine (types 16 and 18)

Source: https://onco.cc/drugs/hpv-bivalent-vaccine/  
OnCo record `hpv-bivalent-vaccine` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Cervarix is a vaccine against HPV types 16 and 18, the two types that cause most cervical cancers, authorised in the EU in 2007 and the US in 2009 after the 18,000-woman PATRICIA trial showed near-complete protection against type-specific precancer. GSK withdrew it from the US in 2016, but it remains WHO-prequalified and used in national programmes, including single-dose schedules.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-24
- Tags: nci-list; prevention
- Brand: Cervarix
- Modality: Recombinant virus-like particle vaccine (adjuvanted)
- Mechanism: L1 capsid virus-like particles of HPV types 16 and 18 with the AS04 adjuvant induce neutralising antibodies that prevent persistent infection with the two types responsible for about 70% of cervical cancers.
- Approvals: 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)

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Cervarix
- US label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Cervarix
- NCI drug page: https://www.cancer.gov/about-cancer/treatment/drugs/recombinant-hpv-bivalent-vaccine
- PATRICIA (Lancet 2009): https://doi.org/10.1016/S0140-6736(09)61248-4
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/cervarix

## Connected records

- drugs: [HPV quadrivalent vaccine (types 6, 11, 16 and 18)](https://onco.cc/drugs/hpv-quadrivalent-vaccine/), [Nonavalent HPV vaccine](https://onco.cc/drugs/gardasil-9/)
- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/)
- technologies: [Cancer interception vaccines](https://onco.cc/technologies/interception-vaccination/), [HPV & HBV vaccination](https://onco.cc/technologies/hpv-vaccine/)
- companies: [GSK](https://onco.cc/companies/gsk/)
- trials: [PATRICIA](https://onco.cc/trials/patricia/)
- key papers: [Efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis](https://onco.cc/key-papers/paper-patricia-paavonen-lancet-2009/)

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