Gardasil not for routine use in males

The ACIP panel stopped short of recommending Gardasil for routine use in boys and men. Experts feel that as a result, insurance companies will not pay for the vaccine for males

New York, October 22 -- The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has advised against the routine use of Merck & Co's (NYSE: MRK) Gardasil in boys and men.

The committee, however, left the option to recommend the vaccine for males with individual doctors.

The panel voted that Gardasil "may be given to males aged 9 through 26 years to reduce their likelihood of acquiring genital warts".

The guidelines of the advisory committee provide the broad framework for national policy on use of the vaccine. Its suggestions are usually accepted by professional medical associations as well as by physicians per se.

Approved vaccine for women
Gardasil is being routinely used to immunize girls and young women against the sexually transmitted virus that causes cervical cancer.

It essentially works against four strains of the HPV. Two of these strains are guilty of causing 70 percent of cervical cancers while the other two strains cause about 90 percent of genital warts.

The vaccine’s use among males has been a moot point ever since it first received the FDA approval for use in females in 2006.

The use of the vaccines in boys and men aged between 9 and 26 was approved by the FDA last week.

Expensive proposition
The school of thought that favors the routine HPV immunization for males avers that since males transmit the virus to females, immunizing the former will reduce cervical cancer rates.

The vaccine, though effective, is costly and requires a series of three injections that cost $130 each.

“What we need is a public policy that gets the resources to where the women are who need it the most,” said Dr. Peter B. Bach, an epidemiologist at Memorial Sloan-Kettering Cancer Center. “But what you end up with is the wealthiest families getting the vaccine for their daughters.”

An analysis on a ‘girls-only vaccination program’ vis-à-vis a co-ed vaccination program was conducted by researchers from the Harvard School of Public Health.

The study established that the cost of giving boys the vaccine far outweigh any health benefit.

"This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money," lead researcher Jane Kim, an assistant professor of health decision science said.

Debbie Saslow, director of breast and gynecologic cancer at the American Cancer Society, opined, “If we can vaccinate a high enough proportion of young girls, then vaccinating boys is not cost-effective."

Meanwhile, the ACIP panel has approved the use of a second HPV vaccine, GlaxoSmithKline's Cervarix, for use in females to prevent cervical cancer. The Merck series costs about $390 and Glaxo's costs about $385.

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