Cervical Cancer Vaccination
The Cervical Cancer Vaccination Debate
In September 2008, there was controversy over the Scottish Government’s decision to choose one cervical cancer jab to treat schoolgirls over another. Since then, health authorities in Spain have withdrawn 76,000 shots of ‘the vaccine of choice’ after two 14-year old girls were hospitalised . They reportedly had convulsions “immediately” after being vaccinated and lost consciousness. Spanish health officials decided to pull the entire batch which had already been distributed.
Manufacturers Sanofi Pasteur MSD, the combination of Sanofi and Merck who market Gardasil in Spain, insist there isn’t a link between the shot and the symptom. But this isn’t the first time the genetically modified vaccination’s made headlines. Gardasil’s been linked to over 1700 adverse reactions and three deaths. An Australian study’s reported young girls receiving Merck’s vaccination had a higher incidence of anaphylactic reactions than those receiving other jabs. Meanwhile Gardasil’s competitor, Cervarix, still isn’t licensed in the US, but it is the UK government’s vaccine of choice for teenage girls. And Swedish anti-corruption agents are also investigating claims drug giant AstraZeneca influenced the awarding of this year's Nobel Prize in Medicine - which went to a scientist for work on the virus causing cervical cancer.  So what is truth behind the cervical jab?
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. They unravelled the body’s immune response to the human papilloma virus (HPV) which has been linked to almost all cases of cervical cancer. This cleared the path for further investigation into the development of vaccines to treat and prevent the cancer. By this time, 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. In October of the previous year, UK experts had already predicted that the vaccine would be available to women within three years, despite stating that it would take several years before the results were known.  The race had begun for GSK and Merck to get their HPV vaccines approved.
Licensing in the UK and US
Merck’s Gardasil was licensed across the EU in September 2006 ahead of GSK’s Cervarix, which was licensed a year later. Both vaccines are used for the prevention of pre-malignant genital lesions and cervical cancer causally related to HPV, but Gardasil protects against more strains of the virus - types 6, 11, 16 and 18 - and external genital warts. Cervarix only works on strains 16 and 18 and is the cheaper alternative.  The British Medical Journal says Cervarix must be £13 to £21 less expensive per dose than the current price of its competitor. That’s a saving of £11.5m to £18.6m from the vaccine price alone in the first year of the programme and ‘implies 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.’  In the US, the situation is different for the pharmaceutical giants. Gardasil was approved by its health regulator, the Food and Drug Administration (FDA), in September 2008. GSK was refused a license after applying in March 2007. The drug giant thinks only minor changes are necessary and the FDA will make a decision in 2009. 
Meanwhile, GSK’s cervical cancer vaccine has already been approved in 67 countries around the world including the 27 member countries of the EU, Mexico, Australia, Singapore and the Philippines. Licensing applications have also been submitted in more than 35 additional countries including Japan.  Schoolgirls between 12 and 13 years of age in Scotland have been routinely recommended the vaccination from September 2008 and there’s a catch-up campaign where girls aged 14 to under 18 years have been offered it. Girls in England and Wales aged 16 to 18 will be offered it from September 2009.
- Woolcock, N. & Rose, D "Parents may boycott cervical cancer jabs after MMR controversy" The Times, 4 September 2008, accessed February 2009.
- Castillo, R. "UPDATE 1-Spain halts batch of Merck's Gardasil" Reuters, 10 February 2009, accessed February 2009.
- Cockcroft, L. "Cervical cancer drug Gardasil linked to deaths" Telegraph, 29 October 2007, accessed February 2009.
- Steenhuysen, J. "Study finds more allergic reactions after HPV jab" Reuters, 1 September 2008, accessed February 2009.
- Rothelius, S.Astra Zenecas samarbete med Nobelstiftelsen ifrågasattDagins Medicin Accessed on January, 29,2008
- Cancer Research UK. 2005) Scientists find clues to new targets for cervical vaccines. Press release, issued 19 July 2005
- Cancer Research UK. (2005) Scientists find clues to new targets for cervical vaccines. Press release, issued 19 July 2005
- BBC News. Vaccine Against Cervical Cancer 29 October 2004. Accessed 8th January 2009.
- EMEA. EPARs for authorised medicinal products for human use. 16 March 2009. Accessed in April 2009.
- Kim, J. (2008) Human papillomavirus vaccination in the UK is projected to be beneficial and cost effective. British Medical Journal. 2008, 337, a842.
- FDA. Product Approval Information. 11 September 2008. Accessed on 8th January 2009
- GlaxoSmithKline. (2008) Cervarix™, GSK’s cervical cancer vaccine, wins tender for UK national immunisation programme. Press release, issued 18 June 2008.