Cervarix HPV Vaccine Description
Cervarix is a non-infectious recombinant, AS04-adjuvanted vaccine, that contains recombinant L1 protein, the major antigenic protein of the capsid, of oncogenic HPV types 16 and 18.
Cervarix was shown to be 93 percent 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.
The majority (approximately 75 percent) 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.
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
October 24, 2016 - GlaxoSmithKline announced they will no longer market its HPV bivalent vaccine, Cervarix, in the United States.
November 4, 2013 - GSK announces data to support Cervarix® two-dose schedule for the prevention of cervical cancer in 9-14 year old girls
October 16, 2009 - GlaxoSmithKline (GSK) announced today that the U.S. Food and Drug Administration (FDA) has 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.