Gardasil

HPV vaccine clears viral infection and may reduce cancerous lesions

Source: www.newswise.com Author: staff Breakthrough study reports complete and partial remissions following vaccination A new vaccine designed to stimulate an immune response against a cancer-causing human papillomavirus (HPV-16) can eliminate chronic infection by the virus and may cause regression of precancerous genital lesions in women who receive the vaccine. According to a report published in the November 5 issue of the New England Journal of Medicine (2009;361:1838-47), the vaccine successfully induced HPV-specific immune responses in 100% of patients with advanced vulvar intraepithelial neoplasia (VIN3), a life-threatening disease that in the majority of cases results from HPV infection and for which there is as yet no satisfactory standard therapy. Among the women who participated in the study, the majority (79%) experienced measurable regression of their VIN3 lesions within 1 year of vaccination. Nine of the women (47%) experienced complete disappearance of lesions and were still symptom-free two years following vaccination. The virus was undetectable in four of five women whose disease had regressed completely after the first year. According to researchers who conducted the phase II study at the Leiden University Medical Center in Leiden, The Netherlands, spontaneous regression of HPV-16 positive VIN3 lesions is very rare, occurring in less than 1.5% of patients. The induction of HPV-specific T-cell immune responses following vaccination, and the researchers’ observation that stronger vaccine-induced immune responses correlated with better clinical outcome indicate that the vaccine is the most likely cause of the high response rate among the patients treated in the study. Unlike recently approved [...]

Oral Cancer Foundation News Team - A2009-11-10T20:37:37-07:00November, 2009|Oral Cancer News|

Males can get HPV vaccine Gardasil thanks, in part, to Gulfport cancer survivor

Source: St. Petersburg Times Author: John Barry David Hastings' crusade to inoculate boys against a cancer-causing virus that afflicts women — but threatened him, too — has scored a victory. But it's not quite the one he has been fighting for in the past three years. A panel of the Centers for Disease Control and Prevention last week allowed a vaccine to be given to boys and young men that is already used to protect girls and young women from human papillomavirus, HPV, which causes cervical cancer. The panel's vote followed the Food and Drug Administration's recent okay of the vaccine for boys as a protection against genital warts. The vaccine, Gardasil, was approved only for females, ages 9 to 26, in 2006. But research has since linked HPV to many oral cancers in men. Hastings, who owns the Habana Cafe in Gulfport with his wife, Josefa, testified before the CDC's Advisory Committee on Immunization Practices. He told them how HPV was found in a deadly carcinoma in his throat in 2006. It took seven weeks of simultaneous chemotherapy and radiation at the H. Lee Moffitt Cancer Center in Tampa to arrest the cancer. Ever since, he has spread the message that HPV is a threat to men. He urged the CDC panel to recommend routine vaccinations for boys, as it already does for girls. Hastings and other proponents argued that only 17 percent of girls are completing the series of three doses needed for protection. "We rely on females [...]

Charlotte Parker2009-10-30T10:58:18-07:00October, 2009|Oral Cancer News|

HPV vaccine fails to get nod for routine use in boys

Source: Medscape.com Author: Robert Lowes October 21, 2009 — Despite hearing impassioned pleas to protect both men and women from cancer, a federal advisory panel today declined to recommend that a human papillomavirus (HPV) vaccine be routinely administered to boys to prevent genital warts. Instead, the Advisory Committee on Immunization Practices (ACIP) issued a "permissive" recommendation stating that physicians have the option of vaccinating boys with the HPV vaccine Gardasil(Merck) for genital-wart protection. ACIP noted that boys should receive the vaccine "before exposure to HPV through sexual contact." In 2006, the US Food and Drug Administration (FDA) approved Gardasil for use in girls and young women to prevent cervical and other cancers as well as precancers caused by HPV types 16 and 18. Last week, the FDA also approved Gardasil for use in males aged 9 through 26 to prevent genital warts. In making its recommendation today, ACIP appeared to be swayed in part by published research questioning the cost-effectiveness of routine vaccination of boys with Gardasil. The committee's decision has far-reaching economic effects because third-party payers typically pay for vaccinations that are recommended for routine use, but not those coming with a permissive recommendation. More at Stake Than Genital Wart Prevention Proponents of routine vaccination of boys with Gardasil told the committee Wednesday during the public comment period that more was at stake than merely preventing genital warts. They underlined the need to also prevent oral, throat, penile, and anal cancers caused by HPV. David Hastings, a spokesperson for the [...]

Charlotte Parker2009-10-26T09:22:06-07:00October, 2009|OCF In The News, Oral Cancer News|

US advisers decline to push Gardasil for boys

Source: Reuters.com Author: Maggie Fox * Committee advises that doctors free to use vaccine * Says needs more evidence of cost benefit * Did not consider value in preventing cancer (Updates throughout, adds quotes, share price) WASHINGTON, Oct 21 (Reuters) - U.S. vaccine advisers declined to press for the use of Merck & Co's (MRK.N) Gardasil in boys and men, opting instead on Wednesday to simply advise doctors they are free to use it. Despite some impassioned pleas from patients and doctors alike, the Advisory Committee on Immunization Practices voted almost unanimously for "permissive" use of the vaccine for boys. It protects against the human papillomavirus, or HPV, which causes a variety of cancers and genital warts. But the committee did recommend including Gardasil for eligible boys aged 9 to 18 in the Vaccines For Children program, a government-funded system that provides vaccines to children eligible for the state-federal Medicaid health insurance plan and other uninsured children. Merck's shares were down 1.7 percent at $33.16 in afternoon trading on the New York Stock Exchange. The U.S. Centers for Disease Control and Prevention currently recommends Gardasil for girls 11 and 12 years old and women 13 to 26 who have not been vaccinated. Earlier this month, the U.S. Food and Drug Administration approved Gardasil for preventing genital warts in boys and men ages 9 through 26. The main reason the vaccine was approved was to prevent cervical cancer, which kills 4,000 women a year in the United States alone. But various [...]

Charlotte Parker2009-10-21T14:45:00-07:00October, 2009|OCF In The News, Oral Cancer News|

FDA approves two HPV vaccines: Cervarix for girls, Gardasil for boys

Sources: www.cancer.gov/ncicancerbulletin Author: news bulletin The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline, announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. Cervarix is a bivalent vaccine, meaning it is specifically designed to protect against two human papillomavirus (HPV) types, HPV 16 and 18, which together are responsible for three-quarters of cervical cancers in North America. Clinical trial data also indicate that Cervarix offers more modest protection against precancerous lesions associated with HPV 31, GSK explained in a statement, as well as other tumor-causing (or oncogenic) HPV types. The company expects the vaccine to be available in the United States by the end of the year. The FDA last week also approved the HPV vaccine Gardasil for the prevention of genital warts in boys. Gardasil is already approved and is being actively used in girls and young women for the prevention of cervical cancer. Gardasil is a quadrivalent vaccine that is designed to specifically protect against infections with four HPV types: 16, 18, 6, and 11. HPV types 6 and 11, which are not considered to be oncogenic, cause genital warts. The agency’s approval of Gardasil for boys aged 9 to 26 is based on data from a randomized clinical trial of more than 4,000 males aged 16 to 26, [...]

Oral Cancer Foundation News Team - A2009-10-21T04:44:55-07:00October, 2009|Oral Cancer News|

Wart virus makes for less deadly cancer

Source: www.montrealgazette.com Author: Maggie Fox A wart virus best known for causing cervical cancer may make for a less-deadly kind of head and neck cancer, researchers reported on Thursday. People whose head and neck tumours carried the human papillomavirus virus, or HPV, were 59 percent less likely to die than people whose tumours were not caused by the virus, the researchers said. "A patient who has this actually has a better prognosis than patients with HPV-negative tumours," Dr. Richard Schilsky, president of the American Society of Clinical Oncology and a cancer specialist at the University of Chicago, said in an interview. He said it may be clear now that there are two kinds of head and neck cancers -- those caused by HPV and those linked to other causes, such as smoking and drinking. Not only can patients be treated differently, perhaps waiting longer for toxic chemotherapy if they have an HPV-positive tumour, but there may be ways to prevent these tumours, Schilsky said. Two vaccines -- Cervarix, made by GlaxoSmithKline, and Gardasil, made by Merck & Co Inc -- prevent HPV-16 infection. "There is every reason to think that vaccination with the HPV vaccine will prevent these," Schilsky said. Dr. Maura Gillison and colleagues at Johns Hopkins University in Baltimore studied 317 head and neck cancer patients whose tumours could be tested for HPV. The phase III study confirms earlier work Gillison's lab did linking HPV and these tumours. They said 87 percent of patients with tumours that tested [...]

Oral Cancer Foundation News Team - A2009-10-16T15:43:55-07:00October, 2009|Oral Cancer News|

Girls aware of HPV vaccine’s benefits

Source: www.sciencedaily.com Author: Dr. Stacy Tessler Lindau, Dr. G. Caleb Alexander Contrary to concerns that the human papillomavirus vaccine might promote promiscuity, a national survey of girls and young women found that the majority of respondents did not believe the HPV vaccine protected them against other sexually transmitted infections. The study, conducted by University of Illinois at Chicago and University of Chicago researchers, appears online and in the November issue of the Journal of Adolescent Health. The findings are reassuring in that girls and young women did not think that the vaccine provided benefits beyond protecting them from HPV, said Dr. Rachel Caskey, assistant professor of pediatrics and general internal medicine at UIC and lead author of the study. "We also found that they did not think that they could stop cervical cancer screening, or pap smears, which is critical." Researchers used a national sample, representative of the U.S. population, to conduct an online survey of more than 1,000 females ages 13 to 26. The data provide some of the first nationally representative estimates of both adolescents' and young women's adoption of the HPV vaccine, barriers to vaccination, and sources of information about HPV and the HPV vaccine, according to the researchers. Knowledge about the HPV virus itself ran the gamut, said Caskey. Some people knew absolutely nothing and a few people were moderately informed. Knowledge about the HPV vaccine, however, was better. "Messages about the vaccine are getting across, though they are not including messages about the virus itself," [...]

Oral Cancer Foundation News Team - A2009-10-16T15:34:41-07:00October, 2009|Oral Cancer News|

FDA approves GlaxoSmithKline’s Cervarix

Source: Philadelphia Business Journal Author: John George The Food and Drug Administration granted marketing approval Friday to Cervarix, the cervical cancer vaccine developed by GlaxoSmithKline. The London pharmaceutical company, which has major operations in the Philadelphia region, said the vaccine will be on the market before the end of the year. The FDA approved the drug for use in women and girls ages 10 to 25. GlaxoSmithKline (NYSE:GSK) will have a challenge taking market share away from Merck & Co. Inc. (NYSE:MRK), which launched its cervical cancer vaccine Gardasil in 2006. Gardasil had worldwide sales of $1.4 billion for Merck last year. Cervarix, which was previously approved in markets outside the United States including Europe, Japan and Australia, had sales of more than $200 million in 2007.

Charlotte Parker2009-10-16T10:56:58-07:00October, 2009|Oral Cancer News|

Study questions whether or not HPV vaccination of boys is cost effective

Source: professional.cancerconsultants.com Author: staff Researchers from Harvard have reported that including boys in a human papillomavirus (HPV) vaccination program may not be cost effective. The details of this study were published online in the British Medical Journal on October 8, 2009.[1] Human papillomaviruses are probably the sole cause of cancers of the cervix and have been associated with cancers of the vulva, vagina, penis, and rectum. Epidemiologic and molecular biology studies have also suggested that HPV infection may be associated with cancers of the head and neck. Gardasil® (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) is already approved by the U.S. Food and Drug Administration for the prevention of cervical, vulvar, and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18 in girls and young women nine through 26 years of age. Cervarix®, a human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine made by GlaxoSmithKline, will probably be approved by the U.S. FDA this year. Male HPV can lead to genital warts, penile cancer, perianal cancer, anal cancer, and head and neck cancer. In addition, it contributes to HPV infection in women and subsequent cervical disease, including cervical cancer. Although males can spread the virus, and many other countries have approved the HPV vaccine for use in males, it has not been approved for males in the United States. However, researchers from the H. Lee Moffitt Cancer [...]

Oral Cancer Foundation News Team - A2009-10-13T21:19:32-07:00October, 2009|Oral Cancer News|

Giving Gardasil to boys not worth the cost?

Source: HealthDay.com Author: Steven Reinberg But other experts dispute finding, and say young men need protection from STDs THURSDAY, Oct. 8 (HealthDay News) -- The cost of giving boys the human papillomavirus (HPV) vaccine would outweigh any health benefit, researchers say. Last month, a U.S. Food and Drug Administration panel recommended expanding use of the Gardasil vaccine to males aged 9 to 26 to protect them from genital warts, but the cost effectiveness of such a program was unclear at the time. But researchers from the Harvard School of Public Health conducted such an analysis comparing a girls-only vaccination program with a co-ed vaccination program. Currently, Gardasil is approved for girls aged 9 and over to protect them from cervical cancer. "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," said lead researcher Jane Kim, an assistant professor of health decision science. The report is published in the Oct. 9 online edition of the British Medical Journal. Vaccination was considered a good value if cost-effectiveness ratios ranged from $50,000 to $100,000 per quality-adjusted life year, meaning the cost of the vaccine vs. the number of added years someone would gain by getting the vaccine. Assuming 75 percent coverage and lifelong protection, the researchers found routine vaccination of 12-year-old girls was a good value at less than $50,000 per quality-adjusted life year. However, adding preadolescent boys increased the cost-effectiveness ratio [...]

Charlotte Parker2009-10-12T11:54:27-07:00October, 2009|Oral Cancer News|