The Food and Drug Administration has declined to approve Gardasil for women 27 to 45 for the second time, asking Merck additional information before any decision to approve the vaccine.

 

In 2006, Gardasil made headlines when it was approved by the FDA as a way to protect against cervical cancer by vaccinating against human papillomavirus, a sexually transmitted virus that can lead to cervical cancer.

 

The vaccine was licensed for use in girls and women aged 9 to 36. However, to be most efficient, the cervical cancer vaccine should be administered to girls before they are sexually active. In September 2008, the FDA updated the label of the cervical cancer vaccine, adding data relating to the protection it offers against vulvar and vaginal cancers.

 

There are more than 100 different strains of the human papillomavirus and approximately 40 of them trigger genital infections. Of those 40, an estimated 50 percent can cause cancer. The four types of human papillomavirus that Gardasil has an effect on lead to 90 percent of genital warts and 70 percent of cervical cancer.

 

In spite of the more than 8,000 complaints about the vaccine that emerged, it proved to be efficient, but only regarding the prevention of those four types of the virus. Therefore, Merck wanted to expand the use of the vaccine to also include women aged between 27 and 45. But in June, the FDA denied approving the vaccine asking the company more information to support the expansion of Gardasil’s use. At the time, Merck submitted 24 months worth of data from a four-year study, showing the drug is also efficient in older women.

 

Now the FDA has asked for the results of that study before making any decision on the vaccine. Merck expects to submit these results to the FDA by the end of 2009, so the drug agency will not be able to grant approval until 2010 at the earliest.

 

Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 280,000 deaths each year. In 2007, there were an estimated 11,000 new cases of cervical cancer and 3,600 deaths in the United States.

 

According to a report released by the federal Centers for Disease Control and Prevention in October 2008, 25.1 percent of the teen girls had received at least one dose of Gardasil. The vaccine is given in a three-dose series. The percentage is encouraging and the CDC hopes it will rise to 90 percent, thus reducing significantly the number of cervical cancer in the United States.

 

The percentage was also good news for Merck considering the fact that back in July Gardasil had been linked to 7,802 reports of adverse events in people who received it.

 

Currently Gardasil is the only cervical cancer vaccine on the market. It has racked up about $1,5 billion in sales since its June 2006 U.S. launch. Cervarix, a similar vaccine made by rival GlaxoSmithKline, is expected to hit the market by the middle of 2009.