GlaxoSmithKline response re hpv vaccine testing in India



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GlaxoSmithKline response re HPV vaccine testing in India
9 Feb 2010
Business & Human Rights Resource Centre invited GlaxoSmithKline to respond to the following item:
- “Women's organisations oppose HPV vaccines ‘against cervical cancer’”, Saheli Women's Resource Centre and Sama Resource Group for Women & Health, 28 December 2009:

http://www.reports-and-materials.org/Saheli-Sama-press-release-28-Dec-2009.doc

In response, GlaxoSmithKline sent the following statement:
“GlaxoSmithKline (GSK) thanks the Business & Human Rights Council for the opportunity to respond the comments made by the Saheli Women's Resource Centre and Sama Resource Group for Women & Health. Below is factual, published and referenced information about Cervical Cancer and GSK’s vaccine to prevent Cervical Cancer.
About Cervical Cancer:
Cervical cancer develops as a result of persistent infection with a cancer causing virus known as human papillomavirus (HPV) 1. The human papillomavirus is extremely common and it is easily transmitted from skin-to-skin contact in the genital area1,2. The virus can be acquired without full sexual intercourse2. Condoms are a helpful preventive measure but do not fully protect women from acquiring the human papillomavirus3. Approximately 100 types of human papillomavirus have been identified in humans to date. Of these, only 15 virus types are considered to cause cervical cancer4. Virus types 16 and 18 account for more than 70 percent of all cervical cancer cases globally4 and 82.5% of cervical cancer in India5.
? Vaccine against Cervical cancer is in the national immunization program of many countries around the world, including UK, US, Australia and most of the European countries.
About GlaxoSmithKline’s vaccine to prevent Cervical Cancer:
Cervarix® is designed to offer women protection against cervical cancer. Cervarix® provides protection against the most common cancer-causing virus types — HPV 16 and 186, 7. These virus types are responsible for over 70 percent of all cervical cancer cases worldwide8. Cervarix® provides further evidence of cross-protection against infection with cancer-causing virus types 31, 33 and 459.

? Virus types 16, 18, 31, 33 and 45 are collectively responsible for up to 81.8 percent of cervical cancer cases worldwide4.

? In June 2009, the WHO granted prequalification for Cervarix®. This means the vaccine can be purchased by UN agencies and the GAVI Alliance in partnership with developing countries.

? To date GSK’s vaccine against HPV, Cervarix® has been approved in over 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico, Taiwan, Japan and the United States.

? Since its launch in 2007, Cervarix has been administered to millions of women. The vaccine has been selected for immunisation programmes in five countries, including national programmes in the Netherlands and the UK and regional programmes across Italy, Poland and Spain.
Cervical cancer develops several years after the infection is acquired, studies have shown that vaccination provides optimal protection if administered before acquisition of oncogenic HPV infection. Moreover, effectiveness of a vaccine is measured on the basis of its ability to protect against CIN2+ lesions.
? As per results of two Clinical Studies conducted for Cervarix® published in 2009, it is confirmed that the vaccine:

(1) Offers protection against five of the most common cancer-causing virus types

(2) Provides high and sustained antibody levels for at least 7.3 years till date
Results from the largest global efficacy trial of a cervical cancer vaccine, involving 18,644 women and published in The Lancet showed that Cervarix® offers Protection’ against the five most common cancer-causing virus types9.
The study showed that in women who complied with the trial protocol procedures (87 percent of the total sample), the vaccine provided 92.9 percent protection against cervical pre-cancers (cervical intraepithelial neoplasia 2+ or CIN 2+) associated with HPV 16 or 18. A further analysis of the same cohort which excluded lesions not likely to be caused by HPV 16 and 18 revealed that the vaccine was 98.1 percent effective against cervical pre-cancers (CIN 2+) caused by these two types9.
The study also showed — for the first time for any cervical cancer vaccine — that Cervarix® provided significant cross-protection against pre-cancerous lesions not containing HPV types 16 and/or 189. This additional efficacy could translate into approximately 11-16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against HPV 16 and 18 alone9. This effect was mainly driven by protection against HPV types 31, 33 and 45.
A long term follow up study- showed that GSK`s Cervarix® provided high and sustained antibody levels against HPV 16 and HPV 18 through the 7.3 years of follow up after vaccination. This is the longest follow up reported to date for any licensed HPV vaccine10.
? Cervarix® contains an innovative, proprietary adjuvant called AS04 which induces a higher and more sustained immune response compared to a conventional adjuvant11.
Adjuvants are substances commonly used in vaccines to enhance the immune response to an antigen. The higher the antibody levels are following vaccination, the higher they are expected to last11.
HPV is a challenging virus that evades the body’s natural immune system and it is therefore important an HPV vaccine induces high and sustained levels of the right type of antibodies12, 13. Cervarix® induces high and sustained antibody levels including neutralising antibodies14 – antibodies that are considered to be a mediator of protection provided by cervical cancer vaccines against HPV15. Furthermore, these antibodies in the blood can transfer to the cervix 16– the site of infection where they are most needed to block the virus from entering the cells17.
Safety and tolerability

Cervarix® is generally well-tolerated. An integrated safety analysis of Cervarix® performed in almost 30,000 women aged 10-72 years from ethnically and geographically diverse backgrounds over a period of up to 5.5 years has shown no clinically significant differences in serious adverse events in women vaccinated with Cervarix® compared to the control group18.


In a more recent analysis of safety data reported over a period of 7.4 years in over 57,000 women aged nine years and above, of which over 33,000 received at least one dose of Cervarix®, the reactogenicity and safety profile of the vaccine was shown to be clinically acceptable, further supporting the safety profile of Cervarix®19.
WHO recognizes the importance of cervical cancer and other HPV-related diseases as global public health problems.
Given below are a couple of points from WHO Position Paper 10 April 2009:
WHO recognizes the importance of cervical cancer and other HPV-related diseases as global public health problems and recommends that routine HPV vaccination should be included in national immunization programmes, provided that: prevention of cervical cancer or other HPV-related diseases, or both, constitutes a public health priority; vaccine introduction is programmatically feasible; sustainable financing can be secured; and the cost effectiveness of vaccination strategies in the country or region is considered. (Ref.: WHO position paper 10 April 2009, Attached file)
Since the immunological correlates of vaccine protection are unknown and the development of cervical cancer may occur decades after HPV infection, regulatory authorities have accepted the use of CIN grade 2 or 3 (CIN2–3) and AIS as clinical end-points in vaccine efficacy trials instead of invasive cervical cancer. Also, using cervical cancer as the outcome in such trials is precluded for ethical reasons. Precancerous lesions usually develop <5 years after HPV infection. If untreated, CIN2–3 has a high probability of progressing to squamous cell cancer, and AIS has a high probability of progressing to adenocarcinoma. The time between initial HPV infection and development of cervical cancer averages 20 years. (Ref.: WHO position paper 10 April 2009, Attached file)
References:

1. Baseman JG, Koutsky LA. The epidemiology of human papillomavirus infections J Clin Virol 2005; 32 Suppl 1; S16-24

2. Schiffman M, Kjaer SK. Natural history of anogenital human papillomavirus infection and neoplasia. J Natl Cancer Inst Monogr 2003; 31: 14-19

3. Winer RL, Hughes JP, Feng Q et al. Condom use and the risk of genital human papillomavirus infection in young women. N Engl J Med 2006 June 22;354(25):2645-54.

4. Bosch FX et Al. Epidemiology and natural history of Human Papillomavirus Infections and Type-Specific Implications in Cervical Neoplasia. Vaccine 26S (2008) K1–K16.

5. WHO/ICO information Centre on HPV and Cervical cancer. Summary report on HPV and cervical cancer statistics in India 2010. [ 04/02/2010]

6. Cervarix™ Product Information 2007 [TBC]

7. Harper DM et al. Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: analysis of a randomised placebo-controlled trial up to 6.4 years. Lancet. 2009 Dec 12; 374(9706):1975-85.

8. Muñoz N, et al. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int. J Cancer 2003; 111: 278-285

9. Paavonen J et al. Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against cervical infection and pre-cancer caused by oncogenic HPV types: final event-driven analysis in young women (the PATRICIA trial). 2009. Published online, The Lancet July 7 2009


10. De Carvalho N et al. Immunogenicity and safety of HPV-16/18 AS04-adjuvanted vaccine up to 7.3y. Abstract presented at the 25th International Papillomavirus Conference (IPV) 8-14 May 2009; Malmo, Sweden

11. Giannini SL, Hanon E, Moris P et al. Enhanced humoral and memory B cellular immunity using HPV 16/18 L1 VLP vaccine formulated with the MPL / aluminium salt combination (AS04) compared to aluminium salt only. Vaccine 2006; 24: 5937-5949.

12. Stanley M. Immune responses to human papillomavirus. Vaccine, 2006; 24 Suppl 1:S16-22.

13. Tindle RW. Immune evasion in human papillomavirus-associated cervical cancer, Nat Rev Cancer, 2002;2:59-65.

14. Harper D, Gall S, Naud P et al. HPV-007 Efficacy Abstract. “Sustained Immunogenicity and high efficacy against HPV-16/18 related cervical neoplasia: Long-term follow-up through 6.4 Years in Women Vaccinated with Cervarix™ (GSKs HPV 16/18 AS04 Candidate Vaccine). Abstract at The Society of Gynecologic Oncologists Annual Meeting (SGO), Tampa, Florida, 9-12 March, 2008.

15. WHO. Expert Committee on Biological Standardization. Guidelines to assure the quality, safety and efficacy of recombinant Human Papillomavirus virus-like particle vaccines, accessed on 27/3/2009 at http://screening.iarc.fr/doc/WHO_vaccine_guidelines_2006.pdf

16. Stanley M, Lowy DR, Frazer I. Chapter 12: prophylactic HPV vaccines: underlying mechanisms. Vaccine 2006;24(Suppl 3):S106–13.

17. Schwarz T, Immune response to human papillomavirus after prophylactic vaccination with AS04-adjuvanted HPV-16/18 vaccine: Improving upon nature. Gynaecologic Oncology. 2008.

18. Descamps D et al. Safety of human papillomavirus (HPV)-16/18 AS04 adjuvanted vaccine for cervical cancer prevention: integrated summary of 11 clinical trials. Human Vaccines 2009:5:5, 1-9;

19. GSK Briefing Document submitted to the Vaccines and Related Biological Products Advisory Committee:



http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM181371.pdf. Accessed on 25 September 2009)”


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