Cervarix HPV Vaccine Description
The Cervarix HPV vaccine is a bivalent, non-infectious recombinant, AS04-adjuvanted vaccine containing recombinant L1 protein, the major antigenic protein of the capsid oncogenic HPV types 16 and 18.
Cervarix was shown to be 93% efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma in situ) associated with HPV 16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination.
About 75% of cervical cancers in North America are caused by HPV types 16 and 18. Cervarix was initially approved for use in the USA in October 2009; however, since 2016, Cervarix is no longer available in the U.S.
However, Cervarix is available in Europe and the UK.
GlaxoSmithKline’s vaccines business GSK Biologicals is one of the world’s leading vaccine companies and a leader in innovation.
Cervarix HPV Vaccine Indication
Cervarix is indicated for the prevention of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18: • cervical cancer, • cervical intraepithelial neoplasia (CIN) Grade 2 or worse and adenocarcinoma in situ, and • cervical intraepithelial neoplasia (CIN) Grade 1.
Cervarix is approved for use in females 9 through 25 years of age.
Cervarix HPV Vaccine Dosage
Cervarix is administered in three doses (0.5-mL each) by intramuscular injection according to the following schedule: 0, 1, and 6 months.
Cervarix HPV Vaccine News
November 3, 2021 - The Lancet published a recent study based in the United Kingdom - The effects of the national HPV vaccination program in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. These researchers estimated that by June 30, 2019, there had been 448 fewer than expected cervical cancers and 17,235 fewer than expected cases of CIN3 in vaccinated cohorts in England.
January 6, 2021 - SK Bioscience announced that it had signed a co-promotion and distribution agreement for major vaccines with GlaxoSmithKline (GSK), a global pharmaceutical company, to expand its share in the local vaccine market and “Cervarix” for cervical cancer.
July 28, 2020 - Worldwide vaccination programs for human papillomavirus (HPV) have evolved substantially over the last decade. There are currently three approved vaccines for HPV: Cervarix, Gardasil, and Gardasil 9. Merck & Co's Gardasil, a quadrivalent vaccine, was first-to-market with its debut in 2006, narrowly ahead of the 2007 release of GlaxoSmithKline's rival bivalent vaccine, Cervarix. Both vaccines are based on the recombinant expression of major capsid antigen L1 from different HPV serotypes, which self-assemble into virus-like particles.
October 24, 2016 - GlaxoSmithKline announced they would no longer market its HPV bivalent vaccine, Cervarix, in the United States.
November 4, 2013 - GSK announces data to support Cervarix® two-dose schedule to prevent cervical cancer in 9-14-year-old girls.
October 16, 2009 - GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration had approved Cervarix® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).
Cervarix HPV Vaccine Clinical Trials
The FDA’s approval of Cervarix was based on data from clinical trials in more than 30 countries involving a diverse population of nearly 30,000 girls and young women receiving Cervarix.