Vaccine against cervical cancer on track for FDA approval

May 17 2006

According to the Food and Drug Administration in the U.S. an experimental vaccine which prevents cervical cancer appears to be effective and has no major safety concerns.

Cervical cancer is the second- biggest cancer killer in women but now a new vaccine, Gardasil, produced by drug company Merck promises to prevent infection from a virus that causes the cancer.

The vaccine has been designed to protect against infection from certain types of the human papilloma virus, or HPV, which causes warts and most cases of cervical cancer.

An FDA advisory panel is expected to recommend clearance for Gardasil which means the vaccine could be approved in early June.

The approval of Gardasil could almost be a lifeline for Merck which is facing thousands of lawsuits concerning the alleged damage caused by the arthritis drug Vioxx which was withdrawn from the market.

The FDA staff reviewers have apparently concurred with the drug company's findings that Gardasil prevented early stage cervical cancer and pre-cancerous lesions in the overall group of women and girls studied.

The FDA also says potential side effects seen in Merck studies are not a safety concern.

It appears that some women and girls who tested positive for HPV when they received the vaccine developed lesions that could become cancerous at higher rates than others who received a placebo shot. But other factors such as smoking probably increased that risk.

Merck carried out studies Gardasil in females aged between 9 and 26 years.

The culprits in 70% of cervical cancer cases are two forms of the sexually transmitted human papilloma virus, types 16 and 18,and they are the targets of Gardasil.

Gardasil offers protection to women from four types of HPV, including 16 and 18, the two responsible for most genital warts.

It is estimated that cervical cancers kill about 300,000 to 500,000 women worldwide each year, including almost 4,000 in the United States, and the vaccine has the capacity to reduce annual deaths from the disease to about 90,000 if it were used globally.

Drug company Glaxo also has an HPV vaccine called Cervarix in the pipeline and plans to seek FDA approval later this year.

Gardasil, if it is approved is predicted to have sales of over $2 billion per year.