Merck to Seek Use of Gardasil in Older Women

Merck & Co. plans to ask the Food and Drug Administration to approve its controversial cervical cancer vaccine Gardasil for use in older women.

Millions of girls, teens, and younger women around the world have received Gardasil shots to prevent cervical cancer and genital warts. The vaccine is now approved for use in females ages 9 to 26 to prevent infection with common strains of the human papillomavirus (HPV) that cause cervical cancer.

Gardasil has been associated with dozens of patient deaths and severe complications ranging from the formation of blood clots, fainting spells, and allergic reactions. At least 47 deaths and thousands of reports of adverse reactions worldwide have been linked to Gardasil vaccinations.

Since its approval in 2006, Gardasil has become one of Merck’s biggest money makers, earning the company $311 million in the third quarter of 2009 alone, though that sum was a drop of 22 percent from previous sales. Still, Merck has been steadily seeking to increase the approved uses of its vaccine.

Last year, the drug company earned FDA approval to use Gardasil in boys and men between the ages of 9 and 26 to prevent them from transmitting HPV to girls and women through sex. Expanding Gardasil’s approved uses has been opposed by some critics, who question the safety and efficacy of the vaccine and say alternative drugs, including the rival vaccine Cervarix, may be just as effective with fewer side effect risks.

Merck is now in the early stages of seeking FDA permission to market Gardasil for women between the ages of 27 and 45, according to a Reuters news report.

In 2009, the FDA refused to grant Merck the permission and asked the drug company to provide the agency with more data after a four-year-long study of the drug had been completed. Merck said this week that it recently provided the requested data to the FDA and that a decision on the broader approval could come in about six months.

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