FDA Panel Recommends Expanding HPV Vaccine Gardasil Use to Men and Boys

The Merck & Co. vaccine Gardasil should be approved for use in men and young boys to prevent cervical cancer in girls who are exposed to the human papilloma virus (HPV) through sexual contact with males carrying the virus, a Food and Drug Administration advisory panel said.

The panel of medical experts said Gardasil should be approved for use in males between the ages of 9 and 26. The final say on whether the vaccine will receive the broader approvals rests with the FDA, which is not obligated to follow the recommendation of its advisory panels, though it most often does.

The panel voted 7-1 that the vaccine is safe for those patients, according to an Associated Press report.

About six million people in the United States are infected with HPV each year. In most cases, the infection shows no symptoms and goes away on its own within two years. However, some people infected develop genital warts and cancers.

Gardasil fights four strains of HPV that are responsible for about 90 percent of all cervical cancer cases. The series of three shots required for the vaccination have been administered to millions of women and young girls worldwide.

Males can carry HPV and pass it to females, most often through sexual contact. It can cause penile and anal cancers as well as genital warts in men, but those diseases are far rarer than cervical cancer in women, which remains the primary target of Gardasil.

Gardasil has been controversial for years. Dozens of users have died from complications triggered by the vaccinations and others have suffered fainting spells or serious allergic reactions to the drug.

The FDA advisory panel reviewed three studies of Gardasil that tested the vaccine in more than 5,000 males between ages 9 and 26. In the studies, the males were given either Gardasil shots or placebo injections for six months then later tested for HPV infection.

Gardasil was 89 percent effective in preventing warts in the study, but was less effective in males who had already been exposed to HPV, officials said. There were no serious side effects detected in the studies, but some patients complained of mild to moderate fever, headache, and skin reactions at the injection site, Merck said.

No related posts.