CDC Calls Merck’s Gardasil Safe

By Anna Boyd
13:47, October 23rd 2008
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CDC Calls Merck’s Gardasil Safe

The Centers for Disease Control and Prevention’s Immunization Safety Office on Wednesday called Merck & Co.’s cervical cancer vaccine Gardasil safe in girls and young women. The vaccine was approved back in 2006.

The report was based on 375,000 doses of the vaccine given from August 2006 to July of 2008. It found that no increased risk of a pre-specific set of possible side effects, such as Guillain-Barre Synfrome, a neurological disorder, stroke, blood clots, fainting, appendicitis and a serious allergic reaction known as anaphylaxis among vaccine recipients compared to a similar group of patients who didn’t receive the vaccine.

The CDC also received more than 10,000 adverse event reports, including 27 deaths as of Aug. 31, 2008. Ninety-four percent of them were reports of events considered non-serious and 6 percent were reports of events considered serious. Most vaccines have reported serious adverse events rates between 10 percent and 15 percent, the CDC said.

“Based on all of the information we have today, CDC and FDA have determined that the HPV vaccine is safe to use and effective in preventing 4 types of HPV,” the CDC said.

Gardasil is given to teenage girls and young women as protection against four strains of the human papillomavirus, two of which accounting for about 70 percent of cervical cancer cases. Last month, Gardasil received FDA approval for vulvar and vaginal cancers as well. These cancers affect more than 5,000 women annually in the United States.

The CDC currently recommends Gardasil for 11 and 12-year-old girls, because nearly none of them has begun their sex lives, and therefore they haven’t been exposed to the virus. For that reason, Gardasil will offer them maximum protection.

According to another report released by the CDC earlier this month, more girls in the US are vaccinated with Gardasil. One in four US girls had received at least one dose of Gardasil, the report showed. 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 US. There were an estimated 11,000 new cases of cervical cancer and 3,600 deaths in the US last year.

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.



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