Difference between revisions of "Cervarix"

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==Background==
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{{Template:Pharma_Portal_badge}}
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'''Introduction'''
 
  
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Cervarix is a recently introduced recombinant
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'''Cervarix''' is a vaccine manufactured by [[GlaxoSmithKline]] ([[GSK]]) used for the 'prevention of cervical cancer' causally related to the human Papillomavirus (HPV). It protects against two strains of the virus - types 16 and 18 - and is cheaper than the rival vaccine on the market, [[Gardasil]].<ref> NHS Immunisation. [http://www.immunisation.nhs.uk/Vaccines/HPV/HPV_and_cervical_cancer HPV and Cervical Cancer] Accessed on April,21, 2009.</ref>
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bivalent HPV vaccine containing purified viruslike
 
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particles of the L1 capsid protein from HPV
 
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types 16 and 18 in a formulation with a novel and
 
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highly immunogenic proprietary adjuvant.
 
  
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'''The Cervarix clinical trial programme'''
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It was licensed by the [[European Medicines Agency]] ([[EMEA]]) in September 2007. As of September 2008, Cervarix was routinely recommended as part of an immunisation programme in the UK by the [[Department of Health]]'s (DoH) [[Joint Committee on Vaccination and Immunisation]] ([[JCVI]]). The committee's [[HPV Sub-group]] played an integral part in the decision-making process to choose Cervarix as the vaccine of choice over [[Gardasil]]. <ref> NHS Immunisation. [http://www.advisorybodies.doh.gov.uk/jcvi/mins-hpv-220906.htm JCVI Advisory Bodies] Accessed on April,21, 2009.</ref>
  
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The pre-licensing programme for Cervarix
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According to the [[British Medical Journal]] ([[BMJ]]), Cervarix must be £13 to £21 less expensive per dose than the current price of the quadrivalent vaccine. This equates to savings of £11.5m to £18.6m from the vaccine price alone in the first year of the programme, and “…implies that the Department of Health is willing to accept foregone health benefits (and additional cost savings) from averting cases of genital warts for the reduced financial outlay, which may be allocated to other priority investments in health”. <ref>Kim, J. (2008) Human papillomavirus vaccination in the UK is projected to be beneficial and cost effective. British Medical Journal 2008, 337, a842.</ref>
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comprised two major clinical trials (a ‘proof-ofconcept’
 
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Phase IIb study and a larger Phase III
 
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trial) encompassing some 19,788 women aged
 
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15–25 years.7,9,11,12 The key features of these
 
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studies are summarised in Table 1. A further
 
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Phase III, community-based, randomised clinical
 
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trial is currently underway in Costa Rica, which
 
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is sponsored by the National Cancer Institute. An
 
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interim analysis of this study has reported on the
 
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effects of Cervarix in women with pre-existing
 
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HPV infections (see below).13 In total, completed
 
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and ongoing clinical trials of Cervarix will
 
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involve nearly 30,000 women and girls aged
 
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between 10 and 55 years.8
 
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In the initial Phase IIb study, vaccine efficacy
 
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was evaluated by examining the impact of
 
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Cervarix on incident and persistent HPV 16/18
 
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infections in women naïve to 14 different high-risk
 
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oncogenic HPV types, including HPV 16 and 18,
 
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and who also had normal cervical cytology (Table
 
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1). This study also included an extension phase,
 
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which evaluated these same parameters with
 
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longer-term follow-up (mean follow-up 47.7
 
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months). Although it is only a surrogate marker
 
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for vaccine efficacy against clinical disease,
 
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persistent HPV infection can be readily
 
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monitored using standard molecular biology
 
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techniques thereby providing substantial
 
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reproducibility between testing centres, in contrast
 
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to the subjective nature of cytological and
 
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histological assessments. However, licensing
 
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authorities now demand that clinical trials of
 
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cervical cancer vaccine also evaluate the incidence
 
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of histological lesions of the cervix including the
 
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incidence of CIN2+, which is now widely
 
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considered to be the most direct correlate of
 
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vaccine efficacy in preventing cervical cancer.14
 
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Although the Phase II study evaluated the effect of
 
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Cervarix on cytological and histological cervical
 
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abnormalities, with extended follow-up of up to
 
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4.5 years, the trial was insufficiently powered to
 
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provide firm evidence of vaccine efficacy.
 
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==Biographical Information==
 
  
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===History===
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[[GSK]] was refused a license for Cervarix in America after applying in March 2007, despite claiming it had submitted data to its regulator, the [[Food and Drug Administration]] ([[FDA]]), from the largest Phase III cervical cancer vaccine efficacy trial conducted around the world to date.<ref>[Vaccine RX. (2007) [http://www.vaccinerx.com/news/cervical-cancer/cervarix---glaxo-hpv-vaccine-filed-with-fda-20070330-160-26.html Cervarix - Glaxo HPV Vaccine Filed With FDA] Accessed on 8th January 2009.</ref>
  
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===Current activities===
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By December 2007, [[GSK]] had received a Complete Response Letter (CRL) from the FDA’s Center for Biologics Evaluation and Research (CBER); a document issued when the review of a file is completed and questions remain to be answered prior to approval.<ref>GSK. (2007) ''GlaxoSmithKline receives FDA ‘complete response’ letter for cervical cancer vaccine''. Press release, issued 17 December 2007</ref> The drug company has since submitted additional information to the regulator, and is still waiting marketing authorisation.
  
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==Views==
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Cervarix has been approved in 67 countries around the world including the 27 member countries of the EU, Mexico, Australia, Singapore and the Philippines, suggests that it is only a matter of time before Cervarix is on the market in the US. Licensing applications have also been submitted in more than 35 additional countries including Japan. <ref>GSK. (2008) ''Cervarix™, GSK’s cervical cancer vaccine, wins tender for UK national immunisation programme''. Press release, issued 18 June 2008.</ref>
  
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==Affiliations==
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==Background==
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==People==
 
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==Funding==
 
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==Clients==
 
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==Publications, Contact, Resources and Notes==
 
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===Publications===
 
  
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===Contact===
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Scientists at the University of Birmingham made a medical breakthrough in 2005, when investigating the major cause of the second most common female cancer worldwide. <ref>Cancer Research UK. (2005) ''Scientists find clues to new targets for cervical vaccines.'' Press release, issued 19 July 2005.</ref> In a study carried out by Cancer Research UK, they unravelled the body’s immune response to the human papilloma virus (HPV,) which has been linked to almost all cases of cervical cancer. The discovery led to a greater understanding of how the immune system’s defence mechanisms work to clear the HPV infection, and cleared the path for further investigation into the development of vaccines to treat and prevent the cancer. <ref>Cancer Research UK. (2005) ''Scientists find clues to new targets for cervical vaccines.'' Press release, issued 19 July 2005.</ref>
  
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:Address:
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By this time however, clinical trials on HPV vaccines were well underway. In June 2005, before the finding was published, a worldwide trial for the vaccine had already closed. It recruited nearly 19,000 women aged 15 to 25 and aimed to see if Cervarix could prevent HPV infection.  <ref>Cancer Research UK. (2005) ''Scientists find clues to new targets for cervical vaccines.'' Press release, issued 19 July 2005.</ref> In October of the previous year, UK experts had already predicted that the vaccine would be available to women within three years, <ref>BBC News. (2004) http://news.bbc.co.uk/1/hi/health/3964263.stm Vaccine against cervical cancer] Accessed 8th January 2009</ref> despite stating that it would take several years before the results were known. <ref>Cancer Research UK. (2005) ''Scientists find clues to new targets for cervical vaccines.'' Press release, issued 19 July 2005.</ref> The race had begun to get the HPV vaccines approved.
  
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:Phone:
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==Question the vaccine and your child may be taken into care==
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In September 2009 the Sunday Times reported that parents who reported negative reactions in their children to the cervical cancer vaccination were being threatened with the prospect of their child being taken into care:
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:The mother of a 13-year-old girl who became partly paralysed after being given a cervical cancer vaccination says social workers have told her the child may be removed if she (the mother) continues to link her condition with the vaccination.<ref>Daniel Foggo, [http://www.timesonline.co.uk/tol/life_and_style/health/article6823345.ece Question a doctor and lose your child], Sunday Times, 6 Sept 2009, accessed 7 Sept 2009</ref>
  
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:Email:
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The girl, Ashleigh Cave, 13, from Liverpool, began experiencing severe headaches and dizziness half an hour after being inoculated in October 2008 with Cervarix:
  
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:Website:
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:The schoolgirl was soon collapsing repeatedly; she lost the use of her legs and was admitted to Alder Hey children’s hospital. Nearly 11 months later she is still in hospital and is unable to stand or walk unaided. Her mother, Cheryl, has now been told that doctors believe her condition must be psychosomatic.
  
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===Resources===
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:“The hospital brought in social workers from the local authority who have told me they are considering putting Ashleigh on an at-risk register,” Cheryl Cave said. She is convinced her daughter’s paralysis was caused by the vaccination.
  
 
===Notes===
 
===Notes===
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[[Category:?]]
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[[Category:Big Pharma]] [[Category:Pharma]]

Latest revision as of 15:05, 7 September 2009

Pharma badge.jpg This article is part of the Pharma_Portal project of Spinwatch.

Cervarix is a vaccine manufactured by GlaxoSmithKline (GSK) used for the 'prevention of cervical cancer' causally related to the human Papillomavirus (HPV). It protects against two strains of the virus - types 16 and 18 - and is cheaper than the rival vaccine on the market, Gardasil.[1]

It was licensed by the European Medicines Agency (EMEA) in September 2007. As of September 2008, Cervarix was routinely recommended as part of an immunisation programme in the UK by the Department of Health's (DoH) Joint Committee on Vaccination and Immunisation (JCVI). The committee's HPV Sub-group played an integral part in the decision-making process to choose Cervarix as the vaccine of choice over Gardasil. [2]

According to the British Medical Journal (BMJ), Cervarix must be £13 to £21 less expensive per dose than the current price of the quadrivalent vaccine. This equates to savings of £11.5m to £18.6m from the vaccine price alone in the first year of the programme, and “…implies that the Department of Health is willing to accept foregone health benefits (and additional cost savings) from averting cases of genital warts for the reduced financial outlay, which may be allocated to other priority investments in health”. [3]

GSK was refused a license for Cervarix in America after applying in March 2007, despite claiming it had submitted data to its regulator, the Food and Drug Administration (FDA), from the largest Phase III cervical cancer vaccine efficacy trial conducted around the world to date.[4]

By December 2007, GSK had received a Complete Response Letter (CRL) from the FDA’s Center for Biologics Evaluation and Research (CBER); a document issued when the review of a file is completed and questions remain to be answered prior to approval.[5] The drug company has since submitted additional information to the regulator, and is still waiting marketing authorisation.

Cervarix has been approved in 67 countries around the world including the 27 member countries of the EU, Mexico, Australia, Singapore and the Philippines, suggests that it is only a matter of time before Cervarix is on the market in the US. Licensing applications have also been submitted in more than 35 additional countries including Japan. [6]

Background

Scientists at the University of Birmingham made a medical breakthrough in 2005, when investigating the major cause of the second most common female cancer worldwide. [7] In a study carried out by Cancer Research UK, they unravelled the body’s immune response to the human papilloma virus (HPV,) which has been linked to almost all cases of cervical cancer. The discovery led to a greater understanding of how the immune system’s defence mechanisms work to clear the HPV infection, and cleared the path for further investigation into the development of vaccines to treat and prevent the cancer. [8]

By this time however, clinical trials on HPV vaccines were well underway. In June 2005, before the finding was published, a worldwide trial for the vaccine had already closed. It recruited nearly 19,000 women aged 15 to 25 and aimed to see if Cervarix could prevent HPV infection. [9] In October of the previous year, UK experts had already predicted that the vaccine would be available to women within three years, [10] despite stating that it would take several years before the results were known. [11] The race had begun to get the HPV vaccines approved.

Question the vaccine and your child may be taken into care

In September 2009 the Sunday Times reported that parents who reported negative reactions in their children to the cervical cancer vaccination were being threatened with the prospect of their child being taken into care:

The mother of a 13-year-old girl who became partly paralysed after being given a cervical cancer vaccination says social workers have told her the child may be removed if she (the mother) continues to link her condition with the vaccination.[12]

The girl, Ashleigh Cave, 13, from Liverpool, began experiencing severe headaches and dizziness half an hour after being inoculated in October 2008 with Cervarix:

The schoolgirl was soon collapsing repeatedly; she lost the use of her legs and was admitted to Alder Hey children’s hospital. Nearly 11 months later she is still in hospital and is unable to stand or walk unaided. Her mother, Cheryl, has now been told that doctors believe her condition must be psychosomatic.
“The hospital brought in social workers from the local authority who have told me they are considering putting Ashleigh on an at-risk register,” Cheryl Cave said. She is convinced her daughter’s paralysis was caused by the vaccination.

Notes

  1. ↑ NHS Immunisation. HPV and Cervical Cancer Accessed on April,21, 2009.
  2. ↑ NHS Immunisation. JCVI Advisory Bodies Accessed on April,21, 2009.
  3. ↑ Kim, J. (2008) Human papillomavirus vaccination in the UK is projected to be beneficial and cost effective. British Medical Journal 2008, 337, a842.
  4. ↑ [Vaccine RX. (2007) Cervarix - Glaxo HPV Vaccine Filed With FDA Accessed on 8th January 2009.
  5. ↑ GSK. (2007) GlaxoSmithKline receives FDA ‘complete response’ letter for cervical cancer vaccine. Press release, issued 17 December 2007
  6. ↑ GSK. (2008) Cervarix™, GSK’s cervical cancer vaccine, wins tender for UK national immunisation programme. Press release, issued 18 June 2008.
  7. ↑ Cancer Research UK. (2005) Scientists find clues to new targets for cervical vaccines. Press release, issued 19 July 2005.
  8. ↑ Cancer Research UK. (2005) Scientists find clues to new targets for cervical vaccines. Press release, issued 19 July 2005.
  9. ↑ Cancer Research UK. (2005) Scientists find clues to new targets for cervical vaccines. Press release, issued 19 July 2005.
  10. ↑ BBC News. (2004) http://news.bbc.co.uk/1/hi/health/3964263.stm Vaccine against cervical cancer] Accessed 8th January 2009
  11. ↑ Cancer Research UK. (2005) Scientists find clues to new targets for cervical vaccines. Press release, issued 19 July 2005.
  12. ↑ Daniel Foggo, Question a doctor and lose your child, Sunday Times, 6 Sept 2009, accessed 7 Sept 2009
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