FDA OKs Gardasil for Boys, Competitor Cervarix for Girls

The Food and Drug Administration today took long-awaited action on two vaccines designed to prevent girls and young women from developing cervical cancer.

The FDA approved giving the Merck vaccine Gardasil to boys to prevent genital warts and keep boys from passing the virus that causes most cases of cervical cancer to females through sex. Gardasil was launched in 2006, but this is the first time the FDA has allowed its use in boys as young as 9 and men up to age 26.

Also today, the FDA approved Cervarix, a competing cervical cancer vaccine made by GlaxoSmithKline, to guard girls and young women against common causes of cervical cancer. Unlike Gardasil, Cervarix does not also target genital warts in boys and men.

Controversial Vaccines Gain FDA Approvals

Both vaccines, which prevent strains of the human papilloma virus (HPV) that cause about 70 percent of all cervical cancers and genital warts, have garnered their fair share of controversy recently.

A recent study found that since its approval, Gardasil has been blamed for at least 47 deaths and thousands of reports of adverse reactions. The FDA and Centers for Disease Control and Prevention say Gardasil is safe with no unusual complications and that side effects such fainting and nausea remain rare.

Last month, an FDA advisory panel recommended that the vaccine be approved for use in young boys and men. However, U.S. researchers said giving boys Gardasil shots to prevent them from passing HPV to girls through sex may not be worth the price.

While the FDA has found that Cervarix is safe and effective for preventing cervical cancer in girls and young women, British health officials recently suspended a Cervarix vaccination program after the sudden death of a 14-year-old girl who received the shot. It was later determined that the girl’s death was attributed to an unrelated medical condition, not the vaccine.

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