|Target disease||human papillomavirus (Types 16 and 18)|
|(what is this?)|
Cervarix is designed to prevent infection from HPV types 16 and 18, that cause about 70% of cervical cancer cases. These types also cause most HPV-induced genital and head and neck cancers. Additionally, some cross-reactive protection against virus strains 45 and 31 were shown in clinical trials. Cervarix also contains AS04, a proprietary adjuvant that has been found to boost the immune system response for a longer period of time.
HPV is a virus, usually transmitted sexually, which can cause cervical cancer in a small percentage of those women genital infected. Cervarix is a preventative HPV vaccine, not therapeutic. HPV immunity is type-specific, so a successful series of Cervarix shots will not block infection from cervical cancer-causing HPV types other than HPV types 16 and 18 and some related types, so experts continue to recommend routine cervical Pap smears even for women who have been vaccinated. Vaccination alone, without continued screening, would prevent fewer cervical cancers than regular screening alone.
Cervarix is indicated for the prevention of the following diseases caused by oncogenic HPV types 16 and 18: cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and CIN grade 1. In the United States, Cervarix is approved for use in females 10 through 25 years of age while in some other countries the age limit is at least 45.
Immunization with Cervarix consists of 3 doses of 0.5-mL each, by intramuscular injection according to the following schedule: 0, 1, and 6 months. The preferred site of administration is the deltoid region of the upper arm. Cervarix is available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes.
Limitations of effectiveness
Cervarix does not provide protection against disease due to all HPV types, nor against disease if a woman has previously been exposed through sexual activity and protection may not be obtained by all recipients. It is therefore recommended that women continue to adhere to cervical cancer screening procedures.
- The most common local adverse reactions in ≥20% of patients were pain, redness, and swelling at the injection site.
- The most common general adverse events in ≥20% of subjects were fatigue, headache, muscle pain (myalgia), gastrointestinal symptoms, and joint pain (arthralgia).
In common with some other prefilled syringe vaccination products, the tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper does not contain latex.
- Human Papillomavirus type 16 L1 protein 20 micrograms
- Human Papillomavirus type 18 L1 protein 20 micrograms
- AS04 adjuvant, containing: 3-O-desacyl-4'- monophosphoryl lipid A (MPL) 50 micrograms adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al 3+ in total
Cervarix is created using the L1 protein of the viral capsid. L1 protein is in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni. The vaccine contains no live virus and no DNA, so it cannot infect the patient.
The research findings that pioneered the development of the vaccine began in 1991 by The University of Queensland investigators Jian Zhou and Ian Frazer in Australia . Researchers at UQ found a way to form non-infectious virus-like particles (VLP), which could also strongly activate the immune system. Subsequently, the final form of the vaccine was developed in parallel, by researchers at Georgetown University Medical Center, the University of Rochester, the University of Queensland in Australia, and the U.S. National Cancer Institute.
As of 2009 the manufacturer was conducting a trial to compare the immunogenicity and safety of Cervarix with Gardasil. Subsequent studies showed Cervarix generated higher antibody levels than Gardasil, the other commercially available HPV vaccine, upon testing seven months later, with twice the level for HPV type 16 and six times for HPV type 18. In addition Cervarix induced twice as many memory B cells as Gardasil for both these HPV strains.
- Australia - Cervarix received approval in May 2007 in Australia for women ages 10 to 45.
- Philippines - On August 25, 2007 GlaxoSmithKline launched Cervarix in the Philippines after approval by the local Bureau of Food and Drugs.
- European Union - Cervarix was approved in September 2007 in the European Union.
- United States of America - The FDA approved Cervarix on 16 October 2009.
- On March 29, 2007 GlaxoSmithKline submitted a Biologic License Application (BLA) for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), to the U.S. Food and Drug Administration (FDA) which included data from clinical trials in almost 30,000 females 10 to 55 years of age and contains data from the largest Phase III cervical cancer vaccine efficacy trial to that date.
- GSK had awaited results of further trials to submit to the FDA. Approval had not been expected before late 2009.
In the UK it was included in the national vaccination programme for teenage and pre-teenage girls aged 12–13 and 17–18 from September 2008 to August 2012. This caused some controversy since Cervarix was chosen over Gardasil, even though Gardasil protects against additional HPV types 6 and 11 (which cause genital warts). However, the efficacy of Cervarix is higher. Although the bivalent vaccine (Cervarix; GlaxoSmithKline) was the vaccine initially offered to schoolgirls, from September 2012, the Joint Committee for Vaccination and Immunisation recommended quadrivalent vaccine (Gardasil; Merck) because it was shown to be more cost effective owing to its additional benefit in protecting against genital warts.
- Centers for Disease Control and Prevention (CDC) (May 2010). "FDA licensure of bivalent human papillomavirus vaccine (HPV2, Cervarix) for use in females and updated HPV vaccination recommendations from the Advisory Committee on Immunization Practices (ACIP)". MMWR. Morbidity and Mortality Weekly Report. 59 (20): 626–629. PMID 20508593.
- "New data show Cervarix, GSK'S HPV 16/18 cervical cancer candidate vaccine, is highly immunogenic and well-tolerated in women over 25 years of age". GlaxoSmithKline. 2006-06-05. Archived from the original on 2007-09-27. Retrieved 2007-01-27.
- "Cervical Cancer Vaccines: Cervarix". Emory University. 2006-08-21. Retrieved 2007-01-27.
- Harper, D. (2009). "Current prophylactic HPV vaccines and gynecologic premalignancies" (pdf). Current Opinion in Obstetrics and Gynecology. 21 (6): 457–464. doi:10.1097/GCO.0b013e328332c910. PMID 19923989.
- Marcia G. Yerman (28 December 2010). "An Interview with Dr. Diane M. Harper, HPV Expert". The Huffington Post. Retrieved 12 January 2010.
- "Cervarix Prescribing Information" (PDF). Retrieved 2010-08-03.
- Glaxo cervical cancer shot approved in Australia Reuters (2007-05-21) Retrieved on 2007-05-25
- Schwarz, T. F. (2009). "Clinical update of the AS04-Adjuvanted human Papillomavirus-16/18 cervical cancer vaccine, cervarix®". Advances in Therapy. 26 (11): 983–998. doi:10.1007/s12325-009-0079-5. PMID 20024678.
- "Latex in Vaccine Packaging" (PDF). Centers for Disease Control and Prevention (CDC). May 2010. Retrieved 2010-08-11.
- http://emc.medicines.org.uk/medicine/20207/PIL/Cervarix/ Patient Information Leaflet
- McNeil, C. (2006). "Who invented the VLP cervical cancer vaccines?". J Natl Cancer Inst. 98 (7): 433. doi:10.1093/jnci/djj144. PMID 16595773.
- Paavonen J, Naud P, Salmerón J, et al. (July 2009). "Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women". Lancet. 374 (9686): 301–14. doi:10.1016/S0140-6736(09)61248-4. PMID 19586656.
- Einstein MH, Baron M, Levin MJ, et al. (October 2009). "Comparison of the immunogenicity and safety of Cervarix and Gardasil human papillomavirus (HPV) cervical cancer vaccines in healthy women aged 18-45 years" (PDF). Hum Vaccin. 5 (10): 705–19. doi:10.4161/hv.5.10.9518. PMID 19684472.
- "Vaccine vs cervical cancer virus launched in Manila". GMA Network. Associated Press. 25 August 2007.
- "Glaxo prepares to launch Cervarix after EU okay". Reuters. 2007-09-24. Retrieved 2008-07-18.
- "FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine" (Press release). GlaxoSmithKline. 16 October 2009. Archived from the original on 19 October 2009. Retrieved 2009-10-30.
- "October 16, 2009 Approval Letter - Cervarix". U.S. Food and Drug Administration (FDA). October 16, 2009. Retrieved 2009-11-13.
- "Cervarix - Glaxo HPV Vaccine Filed With FDA". Vaccine Rx. March 29, 2007. Archived from the original on 2007-09-28. Retrieved 2007-03-30.
- "GSK Does Not Expect FDA Approval Of HPV Vaccine Cervarix Until End Of 2009". Retrieved 2008-07-18.
- Hawkes, Nigel (2008-07-18). "Anger over Department of Health choice of cheaper cancer vaccine". The Times. London. Retrieved 2008-07-18.
- Ireland, Corydon (2006). "A Cancer Vaccine is Born". Rochester Review. University of Rochester. 68 (3).
- McNeil, Donald G., Jr. (August 29, 2006). "How a Vaccine Search Ended in Triumph". The New York Times.
- Official website
- cervicalcancer.gsk.com official global GSK portal for cervical cancer vaccine information
- Cervarix GSK UK Cervarix official site
- Cervarix GSK presentation
- "Human Papillomavirus (HPV) Vaccines", National Cancer Institute Fact Sheet, US National Institutes of Health, October 22, 2009.