Cervarix

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.

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.

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”.

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

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. 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.

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. 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.

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. 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 to get the HPV vaccines approved.