Cervarix – Page 8 – Oral Cancer News

Samuel Broder: Why Isn’t There a Gardasil for Men?

Source: Health.usnews.com Author: Samuel Broder, M.D. There's an HPV vaccine for women; why don't men have one? Why was the vaccine against the cancer-causing, sexually transmitted HPV virus not approved for men at the same time it was for women? Is there any reason to think that men and women would react to it differently? Interesting question. First, a little background. Gardasil is a genetically engineered vaccine to immunize girls and women ages 9 to 26 against four types of human papillomavirus (HPV). HPV is the name given to a family of viruses, many of which can be transmitted from one partner to another through sexual activity. HPV may represent the most frequent sexually transmitted infection in the United States. It is estimated that over 6 million people become infected by a sexually related form of HPV every year. Some estimates suggest that over half of all sexually active males and females become infected at one point or another in their lifetimes. Certain types of HPV can sometimes evade the body's immune system and, when they do, establish a state of persistent infection. That in turn may cause certain cancers. Indeed, this is now recognized as the major cause of cervical cancer and related conditions, and vaccines that immunize people against HPV could make a dramatic impact against these diseases. Gardasil is the first vaccine in the United States approved for the prevention of cervical cancer and precancerous cell abnormalities in the cervix and also certain precancerous conditions in the [...]

Charlotte Parker2009-05-19T15:39:45-07:00May, 2009|Oral Cancer News|

Drugmaker Merck seeks Gardasil approval for boys

Source: www.forbes.com Author: Linda A. Johnson Drugmaker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers. The application was submitted in late December, Merck spokeswoman Amy Rose said Tuesday. It was long planned as part of Whitehouse Station, N.J.-based Merck's strategy to increase the market for Gardasil. It prevents infection with the sexually transmitted virus and thus cancers of the genital organs. Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance. However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen. Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s. The U.S. Food and Drug Administration has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more. The application includes research data from a Merck study including about 4,000 males, ages 16 to 26; Gardasil prevented 90 percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine. The agency approved use of Gardasil in females ages 9 [...]

Oral Cancer Foundation News Team - A2009-01-07T07:17:35-07:00January, 2009|Oral Cancer News|

Study suggests Merck’s Gardasil is effective in males

Source: money.cnn.com Author: Peter Loftus A new study suggests Merck & Co.'s (MRK) Gardasil vaccine, which is primarily given to prevent cervical cancer in girls and women, may also be effective in preventing genital warts and penile cancer when given to males. Merck hopes the company-funded study will support roughly doubling the target population for the vaccine, which could help jump-start sagging sales. The Whitehouse Station, N.J., company said it remains on track to apply by year end for Food and Drug Administration approval to market Gardasil to boys and men ages 9 to 26 for prevention of external genital lesions caused by certain viral strains. "This is groundbreaking data," said Anna Giuliano, professor of medicine and epidemiology at University of South Florida, who co-authored the study. "To demonstrate that Gardasil prevents infection and disease at a very high level in males - that's the other half of the world." It was the first study to demonstrate Gardasil's effectiveness in males - prior studies had shown it could produce a positive immune response in males. The vaccine, which was launched in 2006, is currently approved in the U.S. for girls and women ages 9 through 26 to prevent cervical, vulvar and vaginal cancers, as well as genital warts and other lesions caused by certain viral strains. These diseases, in both males and females, share the same cause: Human papillomavirus, or HPV, which is transmitted through sexual contact. The cancers in men caused by HPV, however, are rarer than cervical cancer. [...]

Oral Cancer Foundation News Team - A2008-11-13T16:09:00-07:00November, 2008|Oral Cancer News|