Source: www.usnews.com
Author: Bernadine Healy M.D.

As women—and soon men—gain access to the new Merck vaccine Gardasil, which targets the sexually transmitted human papillomavirus, the Centers for Disease Control and Prevention has stepped up efforts to identify the 25,000 or more cancers primarily associated with HPV that increase the burden of cancer in the United States each year. As reported in the November 15 supplement to the journal Cancer, the latest figures include 10,846 patients with invasive cancer of the cervix, followed by 7,360 with cancers of the mouth, particularly the tonsils and the back of the tongue. In addition, there are 3,018 cancers of the anus, 2,266 of the vulva, and 828 of the penis.

To the CDC, these are baseline numbers to track the life-threatening consequences of HPV infection. To sexually active young people, this report should be a wake-up call. The hows and whys of catching contagious warts and cancer through sex should be part of every parent’s birds-and-bees talk, every school’s sex-ed curriculum, and—most of all—all young people’s thinking about their own sexual vulnerability. Here are seven need-to-know facts:

1. Infected boys and men are silent carriers of HPV, spewing out their contagion in body fluids. With some strains, visible warts on the genitals bud off fresh virus.

2. Infected girls and young women (particularly vulnerable to infection because of a still-developing cervix) also shed abnormal cells bearing virus into Pap smears, tests that sexually active women should have yearly. The atypical cells usually clear in anywhere from a few months to two years.

3. For well over 50,000 young women each year, the infection hangs on and progresses to a very early in situ cancer of the cervix. If detected before it invades local tissue, it can be cured with a minor surgical procedure. If not, a woman’s fertility and life are threatened.

4. There is no screening test akin to the Pap smear for other HPV infections. Accordingly, the noncervical HPV-linked cancers are detected at more advanced stages, often requiring extensive and disfiguring treatment.

5. Risk factors for HPV include having multiple sexual partners, being under 26 years of age, and practicing oral or genital sex without a condom. Infection risk also increases with smoking, use of birth control pills, and coinfection with other STDs like chlamydia.

6. Except for one’s own strong immune system, there is no medicine to treat an HPV infection.

7. Preventive immunization is a huge advance but not a sure bet. Gardasil targets the four most dangerous strains (HPV 16, 18, 6, and 11), not all. It’s estimated that 30 percent of HPV-related cancers and 10 percent of warts can still slip through.

A universal caution echoed by some of my readers: Even the best vaccine can have side effects and does not eliminate the need for healthful habits and prudent behavior.

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. Gardasil targets four types of HPV that are believed to cause many of the cases of these cancers and lesions. Gardasil is injected in three doses over six months, and costs about $360 in total.

After strong sales growth following its 2006 launch, Gardasil sales have slowed this year, partly because women ages 19 to 26 haven’t been as eager to get vaccinated as Merck had hoped. The vaccine also has been dogged by concerns about its safety, though federal health authorities recently concluded it was relatively safe. Gardasil sales fell 2% to $1.1 billion for the first nine months of the year.

One recent effort by Merck to expand the vaccine’s target population failed. In June, the FDA declined to approve Merck’s application to market Gardasil to women ages 27 through 45.

The new study in males is to be presented Thursday at a medical conference in Nice, France.

The study evaluated about 3,400 men aged 16 to 26 years old who had no signs of lesions at the start of the study. About half were given Gardasil and half were given a fake vaccine, or placebo. The study tracked rates of both genital warts and lesions on or near the penis that are considered potentially precancerous. The study included both heterosexual and homosexual males.

After nearly 30 months of follow-up, there were three cases of such external lesions in the vaccine group, versus 31 cases in the placebo group, for an efficacy rate of about 90.4%, Merck said. Most of the cases were genital warts.

No vaccine-related serious adverse events were reported in the study. A slightly higher proportion of vaccine recipients had injection-site adverse events versus placebo, or 60.1% versus 53.7%. The study is ongoing.

According to the Centers for Disease Control and Prevention, about 1% of sexually active men in the U.S. have genital warts at any one time. Penile cancer is rare, especially in circumcised men, affecting about one in every 100, 000 men in total. HPV also is believed to cause certain oral cancers, but the new Merck study didn’t evaluate Gardasil’s effect on oral cancer.

GlaxoSmithKline PLC (GKS) sells a competing HPV vaccine called Cervarix, which isn’t yet approved in the U.S.

Source: www.medicalnewstoday.com
Author: staff

Gardasil®, the four-type (6,11,16,18) human papillomavirus (HPV) vaccine, has been awarded the 2008 International Galien Prize, a prestigious award for recognising and promoting significant advances in pharmaceutical research which is considered the pharmaceutical industry equivalent of the Nobel Prize.

“It is gratifying to be part of the transformation of scientific breakthrough into actual benefits for people’s health,” says Didier Hoch, President of Sanofi Pasteur MSD. “Only 30 years after the discovery that HPV can cause cervical cancer and many other diseases we hold today a vaccine in our hands that can save lives and prevent the suffering of thousands and millions of women. This is unprecedented progress in medical and pharmaceutical research.”

From 2006 to 2008, Gardasil® has won national Galien Prizes in Belgium, France, Netherlands, Switzerland, the US and the UK (the two HPV vaccines currently licensed for use in the UK were jointly awarded the Galien prize in the palace of Westminster, in September 2008). Additionally, Gardasil® has garnered a number of other prizes, including the 2006 Scrip Award by the British pharmaceutical newsletter Scrip for “Best new biological product” and 2007 Medec Prize by the French general practitioners for “Medicine of the year.”

During the 1970s, Professor Harald zur Hausen, the Co-Laureate of this year’s Nobel Prize in Physiology or Medicine, postulated the role of HPV in causing cervical cancer. He pursued this idea for more than 10 years by searching for different HPV types, which culminated in the discovery in 1983 of HPV 16 as a cause of cervical cancer. In 1984, Harald zur Hausen succeeded in isolating and cloning HPV16 and 18 from patients with cervical cancer.1 Today, it is known that HPV types 6, 11, 16 and 18 cause the vast majority of HPV-related genital diseases.2,3,4

The development of Gardasil® started in the early 1990s. Today, two years after the first approval in 2006, it is approved in 107 countries and widely implemented with 36 million doses distributed worldwide by end of September 2008, and about 90% global market share (in value, implied from public financial disclosures by Merck & Co. Inc and GSK: third quarter 2008: 89.5%, cumulative (year to date): 92.7%). These figures reflect the strong endorsement by experts, regulators, health authorities, physicians, parents and daughters.

Gardasil® is the only four-type (6,11,16,18) human papillomavirus (HPV) vaccine. In addition to cervical cancer protection, Gardasil® is licensed for the prevention of the cervical, vulvar and vaginal pre-cancer, and from genital warts caused by HPV types 6, 11, 16 and 18. These four types together cause the vast majority of HPV-related genital diseases.2,3.4 Gardasil® is available in the UK and is indicated for females 16 - 26 years of age and in 9 to15 years old child and adolescents.

More about Gardasil
Gardasil® is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminate) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil® in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil® should be in accordance with official recommendations.

About International Galien Prize
The Galien Prize was created in 1970 by the French pharmacist Roland Mehl to promote significant advances in pharmaceutical research. Each year, the award, decided by a prominent jury of clinicians, toxicologists, pharmacologists and pharmacists, provides an opportunity to give credit to the most important drugs introduced into the public market as well as to the achievements of the best research team in the pharmaceutical field. Following its initial success in France, similar initiatives started to take off in other countries, including Belgium, Luxembourg, Germany, Netherlands, UK, Italy, Spain, Portugal, Canada, Switzerland and US. A European Galien Prize, the predecessor of the International Galien Prize, was created in 1990 to reward one of the winners of the national Galien Prizes of the two previous years. With the introduction of the Galien Prize in Canada in 1996, the European Galien Prize became the International Galien Prize and is now awarded once every two years. For more information about the International Galien Prize, go to: http://www.prixgalien.com

About Sanofi Pasteur MSD
Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is the only company in Europe dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination. http://www.spmsd.com/

References
1. http://nobelprize.org/nobel_prizes/medicine/laureates/2008/press.html (Last acceded 22 October 2008)

2. Smith JS et al. Human papillomavirus type distribution in invasive cervical cancer and highgrade cervical lesions: A meta-analysis update. Int J Cancer 2007; 121:621-632

3. Gardasil®, Summary of Product Characteristics, September 2008

4. Gardasil®, European Product Assessment Report (EPAR), Scientific Discussion, http://www.emea.europa.e/humandocs/PDFs/EPAR/gardasil/070306en6.pdf

Source: ww.xtra.ca
Author: Andrew Innis

The Nobel Prize winning pioneer of human papilloma virus (HPV) research is calling for the vaccination of boys against HPV.

Speaking at the MaRS Centre in Toronto on Oct 21, Dr Harald zur Hausen argued that vaccination against the viruses, which can lead to cervical cancer in women, is also important to men since they too are susceptible to developing cancers related to HPV.

Zur Hausen said men, like women, need to be protected from the more dangerous strains of the virus, HPV-16 and -18, which can contribute to the development of anal and penile cancer.

The announcement came hours before the release of a report by the US Centers for Disease Control and Prevention (CDC), which confirmed that after two years of clinical usage Gardasil remains safe for human use, citing no elevated risk for neurological complications. The vaccine was approved for use in both Canada and the United States two years ago.

Philippe Brideau, media relations officer for Public Health Agency Canada, said Gardasil has been found to be, “effective and the vaccine is safe, and should be used.” He said there have been no major reactions reported.

Health Canada estimates nearly 75 percent of sexually active men and women will be infected with HPV at least once in their lifetime. While most strains of the virus are of little danger, mainly producing genital warts, it can lead to the development of cancer in both males and females.

Men who have sex with men are at even higher risk, according to studies by the CDC that claim gay and bisexual men may be up to 17 times more likely to develop anal cancer than heterosexual men.

There is also an increased risk of developing cancers of the throat. A 2007 study published in the New England Journal of Medicine found a link between the presence of HPV and a development of oropharyngeal cancer, showing those with HPV had a 32 times higher risk of development.

Most people will eventually eliminate HPV from their body, but those who are HIV-positive or have a compromised immune system are at a greater risk from the virus, making treatment for things like genital warts more difficult.

But the HPV vaccine is not approved for use in males, though Merck, the manufacturer, is holding clinical trials to determine the effectiveness of Gardasil on men.

Sheila Murphy, a spokesperson for Merck, said she is hopeful that preliminary data for the study will be available soon.

“There is going to be a [peer reviewed] meeting in Europe in November, and I was hoping there would be some data presented there, and I still haven’t heard weather that is going to be the case or not,” Murphy said on Oct 27.

When asked if the study could become bogged down by bureaucracy, Murphy was clear that public interest was high.

“We’re talking about a vaccine that prevents cancer, and that will prevent cancer in men… so there’s no question,” she says.

“People are waiting for these results, people like yourselves are clamouring for them.”

But even after the release of preliminary data from the female study, Murphy said it took, “another two years before we had approval of the vaccine, so I would imagine we’re another two or three years away.”

Other countries have allowed boys to be given the vaccine, she said, based on the initial studies on Gardasil. “In Canada… they want us to do the efficacy studies, to show in fact that the vaccine, not only does it cause an immune response recognition, but it actually prevents a disease.”

Source: www.washingtonpost.com
Author: staff

Gardasil, the two-year-old vaccine that’s designed to prevent cervical cancer, is safe, U.S. officials said Wednesday. The U.S. Centers for Disease Control and Prevention’s Immunization Safety Office said a study of 370,000 doses given to girls and young women over the past two years found no evidence that the vaccine causes an increased risk of blood clots or other serious conditions, Bloomberg News reported.

The CDC, which recommends the vaccine for girls starting at ages 11 and 12, based its findings on statistics from the Vaccine Safety Datalink, which uses medical data to test hypotheses about vaccine safety, the news service said.

“There were no associations found that suggested an elevated risk,” said John Iskander, acting director for the Immunization Safety Office, toldBloomberg.

Critics of the vaccine, including some groups that worry that the inoculation could promote promiscuity, have contended that Gardasil may not be safe and could give women a false sense of security about sexually transmitted diseases.

Gardasil protects against four types of genital human papillomavirus, HPV, which is spread through sexual contact and can cause cervical cancer in women.

The U.S. study covered 190,000 girls and young women who received at least one dose of the vaccine’s three-shot regimen. The CDC researchers compared medical data on those girls who got the vaccine with data for girls and young women who received other vaccines or none.

“The results are really reassuring,” said Dr. Paul Offit, chief of the infectious diseases division at Children’s Hospital of Philadelphia. “There’s a public perception that the vaccine is not safe. This is important for countering negative information.”

CDC officials had announced earlier this month that an estimated 25 percent of girls aged 11 to 17 have gotten the vaccine.

“This is very good for a first-year measurement of a new vaccine,” Dr. Lance Rodewald, director of the Division of Immunization Services at the CDC’ National Center for Immunization and Respiratory Diseases, said during a Oct. 9 teleconference announcing the survey. “It usually takes six to nine years to achieve the desired 90 percent coverage.”

Rodewald noted that because the survey covered only young teens, many more young women have probably received the vaccine. The vaccine has been very well-tolerated, and its protection, especially when given at a younger age, is expected to last at least six years, he noted. Whether a booster shot will be needed isn’t known yet.

The hope for the vaccine is that it will reduce the almost 4,000 cervical cancer deaths each year in the United States. Barriers to getting the vaccine include cost, which is about $375, although it is covered under many health insurance plans.

One side effect associated with the vaccine, fainting, resulted in the U.S. Food and Drug Administration last month requiring that vaccine manufacturer Merck & Co. add a warning to the package insert, advising doctors to watch patients for 15 minutes after the shot to be sure they don’t faint.

In July, news stories said that almost 8,000 reports of adverse reactions to Gardasil — including injection site pain and nausea — had been filed with the CDC.

The reactions included 15 reports of death and 10 confirmed deaths, but none of the deaths has been tied to the vaccine, according to aCNNreport.

After the CDC study results were released Wednesday, Merck issued the following statement: “Gardasil is an important tool to help prevent cervical cancer caused by HPV types 16 and 18 for girls and young women. About 30 women every day are diagnosed with cervical cancer in the United States. An estimated 8 out of 10 women will become infected with HPV in their lifetime. For most people, HPV clears on its own. But for some women who don’t clear certain types of the virus, cervical cancer can develop. And there’s no way to predict who will or won’t clear the virus.”

Sources:
U.S. Centers for Disease Control and Prevention, Atlanta;Bloomberg News; Oct. 22, 2008, news release, Merck & Co.

Source: The Oregonian (www.oregonlive.com)
Author: Cynthia Billhartz Gregorian St. Louis

Ten years ago, most of Dr. Brian Nussenbaum’s oral cancer patients were men over 60 who used tobacco and drank heavily. Today, his patients with oral cancer look different. And so does the risky behavior that seems to be leading to their cancer.

Nussenbaum, an ear, nose and throat doctor at Washington University, estimates that 70 percent of his cancer patients have tumors on the back of their tongues and tonsils caused by human papillomavirus-16. Most patients are between ages 45 and 55. About half are women.

And experts suspect that all got the HPV from oral sex.

“We know now that 98 percent of cervical cancer is caused by HPV, and mostly HPV-16,” says Nussenbaum. “But no one talks about how you can also get mouth cancer from it.”

Last week, Dr. Harald zur Hausen, a German doctor and scientist, was awarded the Nobel Prize for medicine for finding human papilloma viruses that cause cervical cancer, the second-most-common cancer among women.

In awarding zur Hausen the prize, the Nobel assembly said he “went against current dogma” in the 1970s when he discovered that certain types of HPV caused the cancer and that the DNA of HPV could be found in tumors.

More than 20 years passed before researchers at Johns Hopkins Kimmel Cancer Center reported a link between HPV and these specific throat cancers in 2000. They and other medical experts suspect the increase in HPV oral cancer stems from a shift in sexual behaviors about 40 years ago, combined with a dramatic decrease in the number of tonsillectomies performed. Cancer from the HPV virus often develop on the tonsils.

In the John Hopkins study, researchers compared healthy people to patients with HPV oral cancer and concluded that people with HPV infections were 32 times more likely to develop the oral cancer than those without HPV. And people who had more than six oral sex partners in their lifetime were 8.6 times more likely to develop the HPV-linked cancer.

These findings have ramifications for anyone who is sexually active. Parents have another reason to think hard whether they want their adolescent daughters, and perhaps even sons, vaccinated with Gardasil, which helps protect against human papillomavirus. And even baby boomers who thought they’d dodged the STD bullet might not have after all.

Experts think HPV lies dormant for years, perhaps decades, before causing the cancer. No one knows how long, because there’s so little data. The National Cancer Institute determined recently that the rate of oral cancer caused by HPV has risen steadily since 1973.

Nussenbaum says a lot of doctors spend very little time, if any, discussing the cancer’s link to oral sex. He’s given second opinions to several patients whose diagnosing doctors never mentioned HPV or its link to sexual behavior.

“In clinic, I let patients direct the conversation,” Nussenbaum says. “I don’t push or force the issue. It can get a bit uncomfortable, especially when there are other family members, like children or spouses, in the room.”

Symptoms of HPV oral cancer can include difficulty swallowing, a sore throat that won’t go away, ear pain and a lump in the neck. Blood tests won’t detect this type of cancer. But blood and saliva tests can detect HPV. None is being used in mainstream clinical settings yet.

The only good news with this type of cancer is that the tumors are highly sensitive to radiation and chemotherapy.

Nussenbaum says that even with stage 3 and 4 HPV cancer, the chance of living for three years is nearly 90 percent. For patients with non-HPV cancer, the survival rate is usually about 55 percent.

Meanwhile, everyone agrees, practicing safe oral sex with condoms and dental dams is the best way to guard against oral HPV, which can lead to the cancer. So is getting the word out that it exists.

Nussenbaum recalls telling a patient that she had HPV oral cancer and that patient turning to her two teenage daughters, looking them right in the eyes and saying, “See. I told you sex can kill you.”

Source: www.therapeuticsdaily.com
Author: staff

A new requirement that girls as young as 11 be vaccinated against a sexually transmitted virus before they can become legal U.S. residents is unfair, immigration advocates say. The federal rule added Gardasil to the list of vaccinations that female immigrants ages 11 to 26 must get before they can obtain “green cards.”

The series of three shots over six months protects against the strains of the human papillomavirus blamed for most cases of cervical cancer and genital warts. But the vaccine is one of the most expensive on the market and controversial.

“This is a huge economic, social and cultural barrier to immigrants who are coming into America,” said Tuyet Duong, senior staff attorney for the Immigration and Immigrant Rights Program at the Asian American Justice Center.

At a cost of $400, Gardasil places an added burden on green card applicants already paying more than $1,000 in form fees and hundreds of dollars for mandatory medical exams, advocates say.

The mandate potentially affects tens of thousands of women and girls annually. More than 200,000 women and girls ages 10 to 29 were granted legal permanent resident status each of the past two years. Past efforts to require the vaccine for American girls has stirred emotional debate and complaints that such mandates intrude on family decisions about sex education.

In Texas, lawmakers last year fought off an order by Gov. Rick Perry requiring the shots for sixth grade girls amid questions about vaccine’s safety, efficacy and cost. Similar programs were proposed in many states, but only Virginia has signed such a mandate into law.

“What surprised us the most is that this requirement is for immigrant girls and women, but not for the general population of natural born citizens,” said Jessica Arons, director of the Women’s Health and Rights Program at the Center for American Progress.

Despite objections by immigrant advocates that the law is invasive and unfair, a spokeswoman for U.S. Citizenship and Immigration Services said the agency must enforce it. The U.S. Food and Drug Administration approved the Gardasil vaccine, made by New Jersey-based pharmaceutical giant Merck & Co., Inc., in 2006. Then last year, an advisory committee to the Centers for Disease Control and Prevention recommended the vaccinations for girls 11 or 12.

For U.S. citizens, the committee’s recommendations serve only to provide guidance on immunization issues. But a 1996 change to America’s immigration laws required anyone seeking permanent residency to get all the vaccinations recommended by the committee.

Jon Abramson, who chaired the CDC’s Advisory Committee on Immunization Practices, said the panel never intended to require Gardasil for immigrants and wasn’t aware its recommendation would become mandatory.

Merck spokeswoman Amy Rose said the drug company did not lobby the government to require the vaccine for female immigrants and that it wasn’t aware of the mandate until after the rule took effect.

The other new vaccines required are for rotavirus, hepatitis A, meningitis and shingles for those older than 60. Routine childhood vaccines such as measles, mumps, and chickenpox are already required.

Source: www.medicalnewstoday.com
Author: staff

The two HPV vaccines currently licensed for use in the UK were jointly awarded the coveted Prix Galien Medal for Innovation at a ceremony held on Wednesday evening in the Palace of Westminster, House of Commons.

“We are absolutely delighted at the recognition given to the world’s leading HPV vaccine Gardasil® - this award reflects the work of many people, all around the world, involved in making the dream of a cancer vaccine a reality”, said Dr Nicholas Kitchin, Medical Director, accepting the award on behalf of the Sanofi Pasteur MSD team.

“Both companies have developed the technology of HPV vaccines down different paths,” he continued, “we chose a quadrivalent vaccine strategy, targeting a broader range of HPV-related genital disease than cervical cancer alone, with the aim of delivering additional benefits for patients and healthcare systems.”

The joint award for the two HPV vaccines, developed by Sanofi Pasteur MSD and GSK, was presented by Andrew Lansley CBE MP, Shadow Secretary of State for Health. The distinguished panel of seven judges, chaired by Professor Sir Michael Rawlins, selected the HPV vaccines as the winners from seven innovative products that reached the final.

Vaccines have won in four of the last five Prix Galien awards and the UK award for Gardasil® follows similar success in Prix Galien competitions in the USA and France.

Current experience with the four-type HPV vaccine

Thirty years after the discovery that human papillomavirus (HPV) can cause cervical cancer, 15 years after the start of vaccine development and two years after the approval of the four-type (6,11,16,18) HPV vaccine Gardasil®, vaccination to prevent cervical cancer and other HPV-related diseases has been widely implemented.

Gardasil® is approved in more than 100 countries around the world. Thirty million doses distributed worldwide demonstrate strong endorsement by medical professionals, regulatory agencies, health authorities and physicians as well as mothers and daughters.

HPV vaccination is recommended in 18 out of the 19 European countries - Austria, Belgium, Denmark, France, Germany, Greece, Iceland, Ireland, Italy, Liechtenstein, Luxemburg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom - in which Sanofi Pasteur MSD markets Gardasil®. The vaccine is funded, or soon to be funded, in 15 of these. It is also recommended and funded in the U.S., Australia, New Zealand and Canada.

Indication of Gardasil®

Gardasil® (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18. The indication is based on the demonstration of efficacy of Gardasil® in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Gardasil in 9- to 15-year old children and adolescents. Protective efficacy has not been evaluated in males. The use of Gardasil® should be in accordance with official recommendations.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between sanofi pasteur, the vaccine division of sanofi-aventis, and Merck & Co., Inc. Combining innovation and expertise, Sanofi Pasteur MSD is dedicated exclusively to vaccines. Sanofi Pasteur MSD is able to draw on the research expertise of sanofi pasteur and Merck & Co., Inc., together with their teams throughout the world, to focus on the development of new vaccines for Europe, which aim to extend protection to other diseases and perfect existing vaccines in order to improve the acceptability, efficacy and tolerability of vaccination.

Sanofi Pasteur MSD is the only European company dedicated exclusively to vaccines

Source: news.com.au
Author: Kate Sikora

The new cervical cancer vaccine is expected to almost eradicate human papillomavirus (HPV) infections in Australian women by 2050 if the high rate of immunization amongst girls continues.

Research to be released today by the Cancer Council NSW reveals the number of new HPV cases in women will fall by more than 50 per cent in the next two years.

In 40 years, the number of cases will fall by 97 per cent.

A national program launched last April has seen 3.7 million girls vaccinated with Gardasil, which has the potential to prevent up to 70 per cent of cervical cancers.

Before the vaccination program, there were 108,000 new infections of HPV16 - responsible for 50 per cent of cervical cancers - every year, but that number is expected to fall to 47,000 by 2010.

Dr Karen Canfell, lead author of the study, warned the reduction in HPV would only occur if girls continued to be vaccinated.

“We expect to see a very fast reduction in the number of new HPV infections, largely due to the high school vaccination program, which we estimate has achieved high coverage of just over 80 per cent of 12-13-year-old girls,” she said.

“This reduction will only occur if we maintain this high vaccination coverage among younger age groups.”

Gardasil has attracted controversy over its rate of adverse reactions.

Nationally, there have been 1013 reports of adverse side effects from Gardasil to the Therapeutic Goods Administration.

Girls have reported allergic reactions, dizziness, fainting and nausea.

Dr Canfell said adverse reactions occurred with any new drug.

“The disease that it protects against is far more harmful than its side effects,” she said.

“It’s really important that parents of girls in school understand they need to have the girls vaccinated.”

Johanna Roberts, 12, is too young to understand the risk of HPV, but she is aware that three jabs from the school nurse could save her life.

“My mum signed the permission slip and I lined up with the other girls,” she said.

Her mother Allison said she would have paid to have her daughters vaccinated if the school program was not in place.

“I have never had a problem with the childhood vaccination program so I didn’t really have a problem with this,” she said.

“If it protects them from having an abnormal pap test then the positives absolutely outweigh the negative side-effects.”