Merck’s cervical cancer vaccine Gardasil recommended for men

Garadasil, a vaccine from Merck & Co to treat cervical cancer in women, has been recommended for use in boys and men.

Gardasil can be used in boys and men belonging to the age-group of 9 to 26 years for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11, Merck said in an official release

Gardasil –recombinant human papillomavirus quadrivalent (Types 6, 11, 16 and 18) Vaccine– use in boys and men 9 through 26 years of age has been supported by US FDA’s Vaccines and Related Biological Products Advisory Committee.

Merck had submitted the supplemental Biologics License Application (sBLA) seeking approval for using Garadaasil in boys in December 2008.

Clinical trials presented to the Advisory Committee evaluated the efficacy, immunogenicity and safety of Gardasil in boys and men 9 to 26 years of age.

Vaccine efficacy in males was evaluated in a randomized, double-blind, placebo-controlled trial involving  4,055 men.  Of these, 3,457 were heterosexual men aged 16 to 23 years and 598 were men who have sex with men aged 16 to 26 years.

Analysis of the clinical data showed that Gardasil was 65.5 percent efficacious against HPV 6, 11, 16 and 18 and 66.8 percent efficacious against HPV 6/11-related external genital warts.

Gardasil generated robust immune responses to HPV types 6, 11, 16 and 18 in 9- to 15-year old boys and 16- to 26-year old men, in immunogenicity studies.

Gardasil has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity.

Garadasil is not recommended for use in pregnant women.

Garadasil is administered in three separate intramuscular injections.  The recommednded dosage schedule is: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

US FDA will consider the committee’s recommendation in its review of sBLA.

However, US FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing vaccines.

Merck expects a decision from the USFDA on the use of Garadasil in men in the fourth quarter of 2009 after the agency has completed its review of Merck’s application.

Gardasil is currently indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18 in the US since June 2006.
Gardasil has also been approved for use in genital warts caused by HPV types 6 and 11 and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

More than 50 million doses of Gardasil have been distributed worldwide through June 2009. Gardasil (sold in some countries as Silgard) has been approved in 112 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

Human Papilloma Virus (HPV) infection

There are more than 100 types of HPV, of which about 30 to 40 types can infect the genital areas of women and men.  HPV types 6 and 11 cause approximately 90 percent of genital warts cases.  About one million people (both males and females) have visible genital warts at any point in time.  There are currently no routine HPV screening methods in place for men.

HPV, a sexually transmitted virus identified as the causative organism behind cancer of the cervix in women, has been recently found leading to at least half of the cancer occurring on the penis of men. Researchers found that HPV16 was the most common among the cases in the studies, accounting for 61.5 percent of cancers. The next most frequent type was HPV18, which was detected in 13.2 percent of cases.  Every year approximately 7,000 cases of penile cancer could be prevented by eradicating HPV16 and 18,study found.

Established in 1891, Merck & Co Inc. is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets vaccines and medicines.