Bloomberg News

Merck’s Gardasil Wins Panel Backing for Routine Use in Boys

November 04, 2011

(Updates with political debate in 14th paragraph.)

Oct. 25 (Bloomberg) -- Merck & Co.’s Gardasil vaccine, used to protect girls from a virus that causes cervical cancer, should also be given to 11- or 12-year-old boys to reduce transmission of the infection, a U.S. advisory panel said.

The Centers for Disease Control and Prevention’s immunization committee recommended routine vaccinations for boys to protect against cancers related to human papillomavirus, or HPV, the Atlanta-based agency said today in an e-mail.

Gardasil aims to prevent sexually transmitted infections that can lead to cervical cancer, genital warts, head and neck tumors and malignancies of the penis and anus in men. Merck, based in Whitehouse Station, New Jersey, won U.S. approval for the vaccine in 2006 for female patients ages 9 to 26; it was cleared for males in that age group in 2009. The shot generated $988 million in revenue in 2010, according to company filings.

Use in boys will protect them against HPV-related cancers and may provide “indirect protection of women” by reducing transmission, the CDC’s Advisory Committee on Immunization Practices said. Decisions by the panel are regularly adopted by the CDC.

“Today is another milestone in the nation’s battle against cancer,” said Anne Schuchat, director of the agency’s National Center for Immunization and Respiratory Diseases, during a conference call with reporters. About 20 million people in the U.S. are infected with HPV, and cancers linked with the virus strike about 18,000 women and 7,000 men yearly, she said.

Recommended Ages

The new recommendation marks “another important step in helping to protect more people from the HPV-related diseases that Gardasil is indicated to prevent,” said Mark Feinberg, chief public-health and science officer in Merck’s vaccines division, in an e-mail.

While the vaccine is most effective when given to 11- or 12-year-olds, the committee said boys as young as 9 can receive it, Schuchat said. The panel also recommended giving the vaccine to males from 13 to 21 who haven’t previously received it.

“The age of 11 or 12 is a very good time to be vaccinated,” Schuchat said. That’s when “antibody or immune responses are the strongest and that’s well before the time girls or boys would become sexually active.”

As of last month, almost 40 million doses of Gardasil had been given in the U.S. and trials show it’s “safe for males and females,” Schuchat said. Side effects include headaches and fever and tend to be mild or moderate, she said.

Changes Past Decision

“There is a misconception that only girls should be vaccinated,” Robert Haddad, chief of head and neck oncology at the Dana-Farber Cancer Institute in Boston, said today in an e- mail. “We strongly believe that both boys and girls should be vaccinated against HPV.”

Today’s finding reverses a 2009 recommendation by the panel that the HPV vaccine should be optional for boys. The panel at the time said the benefits of giving it routinely to 11- to 12- year-old boys wouldn’t justify the costs.

The vaccine costs $108 for patients covered by government health plans, and about $130 for people covered by private- sector plans, Schuchat said.

“The principal reason they strengthened the recommendations is the review of new data that were not available in 2009,” she said. “The idea of having a vaccine that can prevent cancer is a pretty compelling argument to support its use.”

Political Debate

Gardasil became a focus of a Republican presidential debate last month when Texas Governor Rick Perry drew attacks from rivals for issuing an executive order in 2007 that made his state the first to mandate the vaccine’s use in school-age girls.

Representatives of groups advocating abstinence before marriage are among critics who say Gardasil gives women a false sense of security about sexually transmitted diseases and may not be safe. FDA data show that 26 deaths occurred among people who took the drug from September 2010 to September 2011, according to Judicial Watch. The Washington-based group has pushed for the disclosure of Gardasil side effects and says states shouldn’t require girls to get the vaccine.

While 34 deaths have been confirmed of people who have received the vaccine since its 2006 approval, the number is “not at all greater than expected in that population, and the nature and causes of death were a number of different things,” including car accidents, Schuchat said.

“We don’t believe there’s any evidence to support severe life-threatening outcomes associated with this particular vaccine, but safety is an important concern for the advisory committee and we review this regularly,” she said.

Merck is the second-biggest U.S. drug company after New York-based Pfizer Inc.

--With assistance from Tom Randall and Shannon Pettypiece in New York and Alison Fitzgerald and Lisa Lerer in Washington. Editors: Andrew Pollack, Angela Zimm

To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net

To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net


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