"Health Technology Update"

Cervical Cancer Vaccine Trial Generates Huge Headlines

Because of its potential to prevent cancer, HPV vaccine is closely-watched by media

THIS IS AN UPDATE ABOUT THE RACE to be first to market a vaccine to prevent cervical cancer. Merck & Co. is currently in the lead.

On October 6, 2005, Merck released results of a trial that is part of a phase III study of its vaccine, called GARDASIL™ (a “quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine”). In the trial, the vaccine prevented 100% of high-grade cervical pre-cancers and non-invasive cervical cancers.

Approximately 12,000 women from 13 countries participated in this trial. A total of 25,000 women from 33 countries are involved in the full phase III study. Details of the study were widely publicized and are easy to find on the Internet.

Merck expects other trials in the phase III study to be completed shortly. It plans to apply, by year’s end, to the Food & Drug Administration (FDA) for approval to market the vaccine. Under a “best case” timeline, Merck indicates that the HPV vaccine could be sold in the United States during 2006.

Merck’s major competitor in the race to produce an HPV vaccine is GlaxoSmithKline (GSK). Its phase III study has enrolled 35,000 women in 14 countries and is ready to commence. GSK’s vaccine is called Cervarix and it expects to apply for approval in Europe by the end of 2006.

THE DARK REPORT considers the effort to develop a cancer-preventing vaccine to be significant, for several reasons. First, it demonstrates a practical application of molecular technologies to a healthcare problem. In the process, clinical acceptance of this vaccine will eventually alter, in radical ways, the cervical cancer screening protocols that currently apply to every woman in the United States.

Next Round Of Vaccines

Second, few people know about the next wave of vaccines planned to follow introduction of the HPV vaccine into clinical use. At GlaxoSmithKline alone, there are plans to launch five new vaccines over the next five years. These include vaccines for rotavirus gastroenteritis, pneumococcal disease, a new flu vaccine, and new vaccine combinations against meningitis. Glaxo is telling financial analysts that, by 2010, the world market for these types of vaccines will total between $11 billion and $18 billion.

Third, it is important to remember that clinical applications of these molecular technologies will soon multiply exponentially. This raises interesting questions about how diagnostics will change in response to vaccines which prevent disease—and reduce or eliminate the need to perform lab tests for screening and diagnosis of those diseases.

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