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Approved & Available

FDA approved (2009), EMA approved. Widely used in EU national programs.

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Cervarix

Also known as: HPV2 · AS04-adjuvanted HPV-16/18 vaccine

ApprovedPreventive Vaccine
GlaxoSmithKline (GSK) UK / Global Available now — used in many EU national immunisation programs

Cervarix is a bivalent HPV vaccine targeting strains 16 and 18, which together cause approximately 70% of all cervical cancers. Distinguished by its AS04 adjuvant system (MPL + aluminium hydroxide) that drives a stronger and longer-lasting immune response than aluminium-only adjuvants. Cervarix has shown cross-protective immunity against additional HPV strains (31, 33, 45) beyond what it directly targets, giving it broader-than-expected protection. Used in the UK's successful national programme before transitioning to Gardasil 9.

What It Targets

Target Antigen

HPV strains 16 and 18 (L1 protein VLPs with AS04 adjuvant)

Cancers Targeted

CervicalAnalOropharyngeal

How It Works

Like Gardasil, VLPs trigger antibody production. The AS04 adjuvant (monophosphoryl lipid A + alum) activates Toll-like receptor 4 on antigen-presenting cells, generating a significantly stronger Th1 and antibody response — resulting in higher and more durable antibody titres than aluminium-only formulations. Cross-reactive antibodies also provide partial protection against HPV strains 31, 33, and 45.

Key Trial Results

  • 92.9% efficacy against CIN2+ caused by HPV 16/18 in HPV-naive women (PATRICIA trial)
  • Cross-protection: 79.1% efficacy against CIN2+ from HPV 31 (not a direct vaccine target)
  • Antibody titres remain detectable 9+ years post-vaccination with no apparent waning
  • UK programme (2008–2012): 87% reduction in HPV 16/18 prevalence in vaccinated women
  • Finnish study: zero cases of cervical cancer in 11+ years of follow-up among vaccinated girls

Regulatory Status & Availability

Approval Status

FDA approved (2009), EMA approved. Widely used in EU national programs.

Estimated Availability

Available now — used in many EU national immunisation programs

Important Considerations

  • Does not protect against HPV 6/11 (which cause genital warts) — Gardasil 9 covers these additionally
  • Cervical screening remains necessary even after vaccination
  • Injection site reactions and occasional flu-like symptoms
  • As with all HPV vaccines, most effective before sexual debut

iOnco provides this information for educational purposes only. Cancer vaccine availability, trial eligibility, and access pathways change frequently. Always discuss vaccination decisions and clinical trial participation with your oncologist or healthcare provider.