Cervarix - Revision history

Claire Robinson: /* Question the vaccine and your child may be taken into care */

2009-09-07T15:05:58Z

Question the vaccine and your child may be taken into care

Claire Robinson at 15:04, 7 September 2009

2009-09-07T15:04:39Z

Claire Robinson at 15:04, 7 September 2009

2009-09-07T15:04:15Z

Claire Robinson at 15:03, 7 September 2009

2009-09-07T15:03:40Z

Marisa de Andrade at 15:01, 2 June 2009

2009-06-02T15:01:58Z

Claire Robinson at 20:19, 5 May 2009

2009-05-05T20:19:09Z

Claire Robinson at 22:55, 5 April 2009

2009-04-05T22:55:03Z

Claire Robinson at 22:54, 5 April 2009

2009-04-05T22:54:06Z

Claire Robinson at 22:53, 5 April 2009

2009-04-05T22:53:41Z

Claire Robinson: /* Current activities */

2009-04-05T22:51:11Z

Current activities

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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:
 :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>
 ===Notes===

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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>
-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 Sup-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>
+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>
 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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 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>
-[[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>
+[[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>
 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.

← Older revision		Revision as of 15:03, 7 September 2009
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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.		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.
		+
		+	==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.<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>

	===Notes===		===Notes===

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-'''Cervarix''' is a vaccine made by [[GlaxoSmithKline]] that is intended to protect females against the diseases caused by infection with Human Papillomavirus (HPV) types 16 and 18. These diseases include:
+{{Template:Pharma_Portal_badge}}
-Cervarix will not protect against all types of Human Papillomavirus. HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases.
+'''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>
-When a female is vaccinated with Cervarix, the immune system (the body’s natural defence system) will make antibodies against HPV types 16 and 18.
+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 Sup-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>
-==The Cervarix clinical trial programme==
+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>
-From September 2008, HPV vaccination will be routinely recommended for all girls at 12 to 13 years of age. Initially, there will be a catch-up campaign where girls aged 14 to under 18 years will be offered the vaccine.
+[[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>
-==Current activities==
+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.
-Since the Department of Health announced a national vaccination programme against cervical cancer in June 2008, the scheme has rarely been out of the headlines.
+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>
-First, some parents became uneasy that girls as young as 12 were to be immunised against a virus that is transmitted only through sex. It was dubbed the "promiscuity jab". When it was pointed out that the vaccination is most effective before a person becomes sexually active, those fears were replaced with another: that, in other countries, there had been serious reactions to the vaccine.
+==Background==
-The NHS has not changed its advice in the light of these adverse reactions. A Department of Health spokesperson said: "The HPV vaccination programme prevents cervical cancer and will save the lives of up to an estimated 400 women each year. Both HPV vaccines have met the rigorous safety and efficacy standards required for licensing in Europe and elsewhere. It is irresponsible to raise fears over vaccine safety in the absence of scientific evidence that points to safety concerns."
+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>
-==How the vaccine is made and what's in it==
+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.
 ===Notes===
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 <references/>
-[[Category:Big Pharma]][[Category:GM]]
+[[Category:Big Pharma]] [[Category:Pharma]]

← Older revision		Revision as of 20:19, 5 May 2009
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	<references/>		<references/>

−	[[Category:Big Pharma]]	+	[[Category:Big Pharma]][[Category:GM]]

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 '''Prf. Mike Richards''', National Cancer Director at the Deparment of Health.
-'''Helena Bates''', GlaxoSmithKline.
+'''Helena Bates''', [[GlaxoSmithKline]].
-'''Jackie Fletcher''', runs [http://www.jabs.org.uk/ Jabs], a support group for people who believe that they have been damaged by vaccines.
+'''Jackie Fletcher''' runs [http://www.jabs.org.uk/ Jabs], a support group for people who believe that they have been damaged by vaccines.
 '''Dr. Anne Szarewski''', Cancer Research UK.
-===Contact===
+==Affiliations==
 :Address:

@@ Line 1: / Line 1: @@
 '''Cervarix''' is a vaccine made by [[GlaxoSmithKline]] that is intended to protect females against the diseases caused by infection with Human Papillomavirus (HPV) types 16 and 18. These diseases include:
-- cervical cancer(cancer of the cervix i.e. lower part of the uterus or womb),
+- cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb),
-- precancerous cervical lesions(changes in cells of the cervix that have a risk of turning into cancer).
+- precancerous cervical lesions (changes in cells of the cervix that have a risk of turning into cancer).
-Cervarix will not protect against all types of Human Papillomavirus.HPV types 16 and 18 are responsible for approximately 70% ofcervical cancer cases.
+Cervarix will not protect against all types of Human Papillomavirus.HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases.
 When a female is vaccinated with Cervarix, the immune system (the body’s natural defence system) will make antibodies against HPV types 16 and 18.