Gardasil Not for Routine Use in Boys and Men, U.S. Advisory Panel Says

The controversial vaccine Gardasil should not routinely be given to boys and men to prevent spread of a virus that causes most cervical cancers in women, a government advisory panel said today.

Gardasil is made by Merck & Co. and approved to guard against four strains of the human papilloma virus (HPV) which account for about 70 percent of all cervical cancers. The virus also is linked to cancers of the genitals, anus, throat, and genital warts in both men and women. It is most often spread through sexual intercourse.

However, Gardasil has been controversial since its launch in the United States in 2006. A recent medical study found the vaccine has been linked to 47 deaths and people receiving the shots also have reported developing blood clots, severe allergic reactions, and a paralyzing disorder called Guillain-Barre Syndrome.

Still, the Food and Drug Administration recently approved Gardasil for use in preventing genital warts in boys as young as nine and men up to age 26. 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 are rare.

Vote is a Blow to Merck

Today’s vote by the Advisory Committee on Immunization Practices not to recommend routine administration of Gardasil to boys and men is a major blow to Merck. The panel advises the Centers for Disease Control and Prevention in compiling the approved childhood immunization schedule, according to a HealthDay News report. Also, in most cases, inclusion on the list means private insurers will cover the costs of the vaccinations.

A Merck spokesman said the ruling against routine administration of Gardasil to boys and men will limit the use of the vaccine in preventing “a significant personal and public health burden for both men and women.”

“We believe there is value in vaccinating both young men and women with Gardasil to help protect them from certain diseases caused by HPV,” said Merck spokeswoman Pam Eisele.

Panel Also Takes Action on Rival Vaccine Cervarix

Earlier today, the advisory panel said another cervical cancer vaccine, Cervarix, should be recommended for routine use in girls and women to ward off common causes of cervical cancer. Last week, the FDA approved Cervarix for use in girls and women ages 10 to 26.

Gardasil and Cervarix compete for the U.S. cervical cancer vaccine market, but only Gardasil also is approved to prevent genital warts in males.

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