GlaxoSmithKline Statement on UK HPV Immunisation Programme

Posted 24.11.2011

GlaxoSmithKline (GSK) did not participate in the UK’s Human Papillomavirus (HPV) 2011 vaccine tender process.

Cervical cancer protection was the clear public health priority of the UK HPV immunisation programme, which commenced in 2008. ^[1] However, the criteria for this year’s re-tender show that the Government’s priorities have shifted from cervical cancer to also incorporate HPV-related non-cervical cancers and an increased focus on protecting young girls against genital warts.

In 2008, when the overriding priority of the tender selection criteria was to prevent cervical cancer, GSK’s vaccine Cervarix was chosen. GSK’s vaccine was developed to provide girls with effective protection against cervical cancer. Further data have demonstrated that Cervarix offers greater efficacy against cervical cancer than that shown by the data that were submitted during the original 2008 tender process. ^[2] However, Cervarix does not protect against the strains of the HPV virus that cause the majority of genital warts. ^[2]

A recent health economics paper published in the British Medical Journal by Jit et al, concluded that the quadrivalent vaccine may have an advantage over Cervarix in reducing healthcare costs and the QALYs lost, but that Cervarix may have an advantage in preventing death due to cancer. They also concluded that significant uncertainty remains about the differential benefits of the two vaccine. ^[3]

Due to the decreased weighting for cervical cancer and the increased weighting for genital warts in the 2011 HPV vaccine tender GSK chose not to participate. GSK will not participate in tenders where the specifications mean that it cannot effectively compete without undermining the value of our vaccines.

Cervarix, the vaccine that is currently used in the UK HPV immunisation programme, has demonstrated protection against HPV types 16 and 18, ^[2] which are associated with approximately 73% of cervical cancers in the UK. ^[4]

Cervarix is the only vaccine that has demonstrated efficacy against persistent infection with HPV-31, HPV-33 and HPV-45 at six months, which is a pre-cursor to cervical cancer. ^[2] This could translate into 12% additional protection against cervical cancer than protection against types 16 and 18 alone. ^[2]^[5]

GSK health economic modelling predicts that with 80% vaccine coverage among 12 to 13 year old girls in the UK, cross-protection could prevent annually an additional 148 deaths from cervical cancer. ^[6]

Long-term protection is important when vaccinating 12 to 13 year old girls. Cervarix has maintained a high immune response against both HPV 16 and 18 for 9.4 years data to date, the longest published protection for any licensed HPV vaccine. ^[7]

As with all medicines, there are side effects associated with HPV vaccination. The most common side effects associated with Cervarix include injection site reactions such as pain, redness, swelling and fatigue. ^[2] At least five million doses of Cervarix have been administered in the UK up to July 2011. ^[8] The UK medicines regulatory agency regularly reviews all reported suspected adverse events and has concluded that the balance of benefits and risks remains positive. ^[9]

The full Summary of Product Characteristics for the vaccine including a summary of all data and listed side effects can be found on the electronic Medicines Compendium (eMC) website at: http://www.emc.medicines.org.uk/ .

Every day in the UK eight women are diagnosed and three women die of cervical cancer. Cervical cancer is the most common cancer in women under 35 years old.^[10]

Simon Jose, General Manager, GlaxoSmithKline UK, said: “This was a difficult decision for us to make but the criteria for the tender were changed. We are proud to have played our part in the success of the UK’s first HPV immunisation programme which has uptake among the best in the world. Latest figures show that more than 84 per cent of girls aged 13 to 14 have helped to protect themselves against cervical cancer by getting all three doses of GSK’s vaccine.

“GSK remains fully committed to supporting public health in the UK where we continue to supply the Government with our vaccines as part of the national immunisation schedule. We will continue to work with health authorities globally and are committed to making Cervarix available to women around the world.”

Cervarix will continue to be available in the UK, but from September 2012 will not be the vaccine used for the routine school-based HPV immunisation programme.

References:

Annual HPV vaccine coverage in England in 2009/2010, Department of Health, January 2011.
Cervarix Summary of Product Characteristics.
Jit et al. Comparing bivalent and quadrivalent human papillomavirus vaccines. BMJ 2011;343:d5775 doi: 10.1136/bmj.d5775
Howell-Jones et al. HPV type-specific prevalence in women in England. British Journal of Cancer (2010) 103, 209 – 216.
Paavonen, J. et al. 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 2009;374 (9686)
Pearce D and Demarteau N. Impact of HPV vaccination on mortality due to cervical cancer in the UK. IPvC. Montreal, Canada 2010.
Naud et al HPV-16/18 Vaccine: Sustained Immunogenicity and efficacy up to 9.4 years.
House of Commons Hansard Written Answers for 06 July 2011. Accessed August 2011.
MHRA Public assessment report. Cervarix (HPV vaccine): Update on UK safety covering the first two years of the HPV immunisation programme 2010. Accessed June 2011.
Cancer Research UK. Cervical Cancer - UK Incidence Statistics 2010. Accessed August 2011.

Cervarix is a trade mark of the GlaxoSmithKline group of companies.

B.M.: Last updated 24 November 2011: UK/CER/0085/11

GlaxoSmithKline Statement on UK HPV Immunisation Programme

Posted 24.11.2011

References:

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