Merck Wins U.S. Approval for Gardasil Vaccine in Boys

Oct. 16 (Bloomberg) — Merck & Co.’s Gardasil, a vaccine used to prevent cervical cancer in women, won U.S. regulatory approval for preventing genital warts in boys.

The U.S. Food and Drug Administration cleared the vaccine for use in males ages 9 to 26, Merck said today in a statement.

Gardasil protects against a sexually transmitted infection called human papillomavirus, or HPV, that can lead to cervical cancer in women and genital warts and cancer of the penis and anus in men. Gardasil, approved for females ages 9 to 26, is given mostly to school-age girls as a U.S.-recommended routine vaccination. Expanding the shot’s use could revive sales, which declined 5 percent last year, analysts have said.

“This is an important milestone, because the use of Gardasil can now help protect boys and girls and young men and women from certain diseases caused by this common virus,” said Richard Haupt, executive director of Merck Research Laboratories, in the company’s statement.

Approval in boys could add as much as $200 million and $300 million in annual sales, said Leerink Swann & Co. analyst Seamus Fernandez in a research report last month. Gardasil generated revenue of $1.4 billion last year.

Merck, based in Whitehouse Station, New Jersey, fell 6 cents, or less than 1 percent, to $33.24 at 1:26 p.m. in New York Stock Exchange composite trading.

Difficult Market

Selling Gardasil for boys could be a struggle for Merck because the public-health benefit may not outweigh the expense, Fernandez said. It would cost more than $100,000 to vaccinate enough boys to get one year of additional life compared with less than $50,000 for girls, according to a study by Harvard University researchers presented in June to the U.S. Centers for Disease Control and Prevention. Merck’s studies show it would cost $50,000 for both boys and girls. Merck’s study used a cost of $400 per vaccine with 100 percent protection.

Researchers used a measure called quality adjusted life years, or QALYs, that evaluate years of life saved as well as assigning a fraction of a year for years spent without certain diseases.

Merck will expand a patient rebate and dose replacement program to help cover the cost of the vaccine for 19- to 26- year-old men without health insurance and those with private insurance with partial or no coverage for the shots, according to the company’s statement.

Company Study

In a Merck-funded study released last year, researchers gave 4,065 boys and men ages 16 to 26 the vaccine or a placebo, then tracked them for signs of infection with HPV. After about 30 months, three men getting Gardasil developed genital warts and none had pre- cancerous growths linked to the HPV virus, compared with 28 cases of warts and three pre-cancerous lesions in the placebo group.

Gardasil, which is given in three shots over a six- month period, protects against infection caused by HPV types 6, 11, 16 and 18 — four of the 40 types of the virus found in the genital area. More than 1 million cases of genital lesions, which can lead to cancer, occur in men and women in the U.S. each year, and 30 million cases occur worldwide, according to Merck.

While 20 million Americans are infected with HPV, most will be able to fight off the infection naturally. About 1 percent of sexually active men in the U.S. will develop genital warts from HPV, the CDC said. Gardasil is already approved for males in 40 countries worldwide.

Second girl from Natalie school in 999 drama after cervical jab

Another schoolgirl at Blue Coat Church of England School needed an ambulance after having the cervical cancer jab, it emerged last night.

The 15-year-old pupil became cold, weak and dizzy less than an hour after the vaccine and only a short time after schoolmate Natalie Morton became fatally ill.

Her symptoms were so severe that paramedics did emergency blood tests and an ECG scan in a back room at the school, the girl’s mother said.

Her twin sister also had the vaccine on Monday but suffered only a sore arm and tiredness. Neither have any allergies.

Last night the mother criticised Blue Coat School for failing to contact her and check on her daughter’s condition.

NHS Direct advised that she monitor her daughter and wake her during the night to check her responsiveness.

Natalie MortonTragic: Natalie Morton

The mother, who has five children including twins, told the Daily Mail: ‘She was and still is really quite ill. I don’t know what caused it but she went to school perfectly healthy and became sick soon after the vaccine.

‘Now she’s completely out of sorts.

Paramedics said she might have been low on blood sugar because she hadn’t eaten lunch. But that’s not true  –  she did have lunch on Monday.

‘It’s a very anxious time. My daughter knew Natalie from seeing her around school and she’s petrified that whatever killed Natalie might have got to her too.

‘I’m angry that the school sought emergency medical help but haven’t followed it up at all. What happened is tragic for Natalie but where is the help in place for the girls who suffered side effects?

‘The school could face further tragedy unless they look after the victims of what seem to be horrendous symptoms from this cervical cancer vaccine.’

Girl Rejects Gardasil, Loses Path to Citizenship


Teen Asks Why She Should Take Vaccine If She is Not Having Sex, Worries About Dangers

Born in Britain in 1992, Simone Davis got off to a rough start in life. Her biological mother abandoned her as a baby, and her father couldn’t care for her.

At 3, Simone was adopted by her paternal grandmother, Jean Davis, who married an American in 2000 and moved them to Port St. Joe, Fla.

But because the adoption was not recognized in the United States, Davis embarked on a near-decade quest to get Simone U.S. citizenship.

Now 17 and an aspiring elementary school teacher and devout Christian, Simone has only one thing standing in the way of her goal — the controversial vaccine Gardasil.

Immigration law mandates that Simone get the vaccine to protect against the sexually transmitted human papillomavirus, which has been linked to cervical cancer.

But Simone, who has taken a virginity pledge and is not sexually active, doesn’t see why she should have to take the vaccine, especially since it’s been under fire recently regarding its safety .

And none of her American classmates is mandated by law to be vaccinated.

“I am only 17 years old and planning to go to college and not have sex anytime soon,” said Simone. “There is no chance of getting cervical cancer, so there’s no point in getting the shot.”

Since 2008, the government has required that female immigrants between the ages of 11 through 26 applying for permanent resident or refugee status receive Gardasil, which was approved by the Food and Drug Administration in 2006.

Simone and her adoptive mother she still calls “Nanny” sought a waiver for moral and religious reasons and were recently rejected by the U.S. Citizenship and Immigration Services.

That ruling threatens to separate Simone and Davis, and could dash the teen’s plans to attend Pensacola Christian College, where she was conditionally accepted.

They were given 30 days to appeal or the teen would face being “removed.”

The 1996 Immigration and Naturalization Act requires girls and women within a specified age group to receive the vaccination against certain specified diseases “and any other vaccinations recommended by the CDC’s Advisory Committee for Immunization Practices.

Gardasil was added to the list of vaccines in 2008.

“The decision to include HPV as a required vaccine was made by the CDC,” said Citizenship and Immigration Services spokeswoman Chris Rhatigan.

“We follow the law,” she told “The objection to a waiver would have to be to all vaccines, not just Gardasil.”

The CDC is expected to publish new criteria to determine which vaccines should be recommended for U.S. immigrants in about a month, according to spokeswoman Christine Pearson.

Simone’s struggle began in 2000, when U.S. authorities did not recognize the British adoption papers, and the process began anew.

“We never heard from her mother again after she sent a third birthday card, and was never given a contact address,” said Jean Davis, who is now 63, divorced, and a teacher. “I had no idea where she was.”

The Salvation Army Missing Person’s Bureau traced Simone’s biological mother, and the American adoption was finalized in 2006.

Local churches helped pay more than $1,700 immigration application fees for Simone’s permanent residency status, the first step toward citizenship. For another $585, Davis can appeal, but says she doesn’t have the money.

Citizenship Dashed by Gardasil

If Simone does not become a permanent resident by her 18th birthday in January, she willl have to reapply as an adult and wait five years before she can even be eligible for citizenship.

“I kind of feel like they may be experimenting with immigrants to see how we will react and then give the vaccine to citizens,” said Simone. “I told Nanny that if it is such a great vaccine, why isn’t it mandatory for everyone?”

Gardasil must be administered before the age of 26 to be effective, according to FDA guidelines. It protects against HPV types 6, 11, 16 and 18. Almost 70 percent of cervical cancer cases and 90 percent of genital warts are linked to these four strains.

About 12,000 women a year are diagnosed with cervical cancer, which kills about 4,000 annually, according to the CDC.

The vaccine can cause fainting, redness and inflammation at the site and fever. The most dangerous side effect, which has alarmed some gynecologists, is an increase in blood clots, which, according to an article in the Journal of the American Medical Association (JAMA), may have caused 32 unconfirmed deaths.

In an accompanying editorial, the journal complained about the lack of concrete evidence that the vaccine is effective.

When Gardasil was added to the vaccine list last year, it drew anger and protests from immigration advocates, who argued that it placed an unfair financial burden on women. A three-shot series of the vaccine can cost between $300 and $1,400.

Some health care policy experts suggested the requirement was excessive and unnecessary. Of the 14 required vaccines, 13 are designed to combat infectious diseases that are considered highly contagious. But Gardasil targets a virus spread through sexual contact.

Though 18 states are currently debating whether to make the vaccine mandatory, none, so far, require it.

“I am most definitely surprised and I would love to know how it ever became policy,” said Dr. Jacques Moritz, director of gynecology at St. Luke’s-Roosevelt Hospital in New York City. “I wonder if the drug company could have had any influence.”

“It’s a voluntary vaccine, and for the U.S. government to make it a mandatory decision to come to this country is crazy,” he told “It has no public health value that has been shown.”

Merck & Co., which makes Gardasil, said it had no involvement in the enactment of the mandate.

“Merck recognizes that many individuals and groups are concerned over this requirement and emphasizes that, while we encourage all women to be educated about HPV-related diseases, the company does not support mandatory vaccination of new female immigrants,” said Merck spokeswoman Pam Eisele.

The company said it has an “extensive and ongoing” safety-monitoring program and does not believe that reported deaths have been caused by Gardasil.

“Nothing is more important to Merck than the safety of our medicines and vaccines,” she told “We are confident in the safety profile of Gardasil.

The company garnered $1.4 billion in sales last year. According to the business publication Medical Marketing and Media, the company has “captured lightning in a bottle” with its direct-to-consumer marketing to mothers and their daughters, encouraging them to talk to their doctors about protection from HPV.

Just this week, an advisory panel recommended that the FDA allow doctors to prescribe Gardasil to boys and men ages 9 to 26 to help prevent genital warts, which have been linked to the transmission of HPV.

Moritz, himself, has chosen not to have his 11-year-old daughter vaccinated, as long as good cervical cancer screening tests, like the Pap smear, exist.

“I’m pro-preventing cervical cancer,” he told “But I’m not that pro that the physicians don’t know the risks and side effects.”

But Dr. Mark Einstein, associate professor of obstetrics and gynecology at the Albert Einstein College of Medicine and Montefiore Medical Center in New York, disagrees.

“Every scientific stakeholder has advocated for use of this vaccine,” he told “The more serious side effects may not be vaccine related. The most recent report in the JAMA was positive, reinforcing the safety of a vaccine that been delivered to 26 million in the U.S.”

Einstein said cervical cancer was “not just a Third World Disease.” American women are struck in their “reprodictive prime,” and radiation treatments can cause sexual dysfunction and child-bearing problems.

“I have a busy clinical schedule,” said Einstein. “The death rate is low because the treatments are very effective. But the treatments are toxic and have very serious side effects through life.

“We have a lot of opportunity to prevent [cervical cancer] before it happens and shift the future of a disease,” he said.

Einstein also debunks Simone’s claim that she doesn’t need the vaccine because she is not having sex.

“Quite frankly, from a science standpoint and outreach, everyone does ultimately as an adult have sex,” he said.

But her adoptive mother, Jean Davis, said the issue is about more than chastity.

“All we want is the rights of a U.S. citizen,” said Davis, who has scoured the Internet for research on Gardasil and sent letters to all her political leaders, including the president. “It’s not mandatory for them to get this. That’s our objection.

“My choice to make an informed decision for the health of my child has been taken away,” she told “I have been like a crazy woman, I have been so upset about this. I am really in a panic.”

“How can they call this America, the land of the free?” she asked. “Where are my parental rights?”

Give Gardasil to boys too, experts say

Recent evidence shows the human papilloma virus (HPV), which causes cervical cancer in women, is poised to become one of the leading causes of oral cancer in men because of changing sexual behaviours.

The findings have reignited the debate over whether boys should be given the cervical cancer vaccine, Gardasil.

A visiting British virologist, Professor Margaret Stanley, says governments around the world need to examine the long-term economic and health benefits of immunising boys and young men.

The head of Microbiology and Infectious Diseases at Melbourne’s Royal Women’s Hospital, Professor Suzanne Garland, says Australia is leading the way in the rollout of the cervical cancer vaccine Gardasil, which immunises against HPV.

“We are in our third year of rolling out the vaccine and we are in the order in the school-based group, in the high 70s, whereas in many other countries, they have only got 30 per cent who have been vaccinated,” she said.

But now the vaccination debate has switched genders.

There are growing calls from the medical community for boys and young men to also be vaccinated against HPV.

Advocates include one of Britain’s top cervical cancer specialists, Professor Margaret Stanley from Cambridge University, who says a cervical cancer jab in the arms of boys would not just be for the sake of girls.

“These HPVs don’t just cause cancer in women. They cause it in men as well. Cancer in the mouth, cancer in the anus and those cancers are very hard to treat,” she said.

“As an anti-cancer prevention strategy, I would have thought immunising boys was a sensible way to go.”

Professor Stanley is visiting Melbourne as the guest speaker at a cervical cancer conference at the Royal Women’s Hospital.


She says the rate of oral cancers linked to HPV is rising, and it is strongly associated with an increase in the practice of oral sex.

“There are some caused by alcohol and tobacco use and they are declining, but there is no doubt that the cancer caused by HPV are on an upward trajectory,” she said.

Professor Suzanne Garland says there would be other benefits to vaccinating men against HPV.

“I think it would also help destigmatise this just being a female disease,” she said.

The benefits exist, but critics say they do not outweigh the cost of a government-funded vaccination program for boys and young men.

However Professor Stanley rejects that categorically.

“The cost-effective modelling that is being done at the minute has actually not taken into account these other cancers,” she said.

“It has really only looked at ‘if we immunise boys, what effect will we have on cervix cancer’ and I think they need to go back to their models and say ‘if we immunise boys, what effect will have on these other cancers and what value for money will that be’.”

Germany’s Robert Koch Institute is Questioning the effectiveness of the HPV vaccines

All around the world concerns are mounting about the effectiveness and the safety of the HPV vaccines. Whilst many of our Governments refuse to listen to public concern and ignore the ever increasing numbers of children who have had adverse reactions to the Gardasil and Cervarix vaccines, in Germany their concerns are at last being looked at and examined carefully.

The Robert Koch Institute in Germany which makes recommendations on the public funding of vaccines, is reviewing its vaccination programme after 13 experts called for a reassessment of its HPV vaccination programme and an end to “misleading information” about the effectiveness of the jab.

Scotland on Sunday reported a few weeks ago – A spokeswoman for the Robert Koch Institute said its vaccination committee was reviewing the situation, adding: “Because of the public discussion and some new reports and new statements from the 13 professors, the committee will publish a statement within the next few weeks.”

Scotland to, is seriously looking into it’s vaccination policy as regards the vaccine Cervarix due to the concerns of the papers written by the German Scientists as Sandra H Chevalier-Batik reports

“SCOTLAND´S multimillion-pound cervical cancer vaccination programme was thrown into doubt last night after senior public health experts warned it might not be as effective as initially hoped. Government advisers in Germany are reviewing the program there after leading scientists said the jab was failing to live up to expectations on the number of cervical cancer cases it might prevent.

Now critics say Scottish health advisers, who gave the go-ahead for a £64 million immunization program involving thousands of schoolgirls, should review the evidence as well. The HPV vaccine protects against two strains of the human papilloma virus, which are responsible for most cases of cervical cancer. About 100 Scottish women die of the sexually transmitted disease every year.”

In the past few weeks professionals and concerned mothers from the USA, UK and Holland have come together and decided to write to these 13 scientists outlining their concerns. These concerned individuals have each come into contact with the victims of these vaccines and armed with newly revealed evidence they decided to email these scientists direct. They have drawn up papers which they have sent to these scientists backed up with their evidence and statistics showing that their concerns are indeed warranted. These papers were then sent to 700 professionals worldwide.The professionals who received them are from the medical profession, scientists, Governments , Journalists and many more. They are being put up on websites all over the world. Last night Cynthia Janak one of the authors of the USA paper sent an email to the other authors which said:-

“I just received an email from an oncologist and he agreed that the safety has not truly been proven because of the documents we have presented.”

Professionals in general have said the papers were well presented and extremely well written.

This morning this was quoted in an email to one the authors of the UK paper Freda Birrell.

“Never doubt that a small group of thoughtful, committed citizens can change the world. Indeed, it is the only thing that ever has.”

—Margaret Mead, US anthropologist & popularizer of anthropology (1901 – 1978)

Profitable Harm is one of the many sites that now have a copy of these documents .

To understand how HPV vaccines and other vaccines cause brain damage, listen to the radio programme on Monday 1st June 2009 6-7 pm MST and hear the answer to the question ‘Do Vaccines Cause Brain Damage?’ Tune into KRFC FM 88.9 to listen to the audio streamed programme where Dr Andrew Moulden the leader of the Canadian Action Party will be explaining the subject of Neurological Vaccine Damage to Leslie Botha from Holy Hormones, Honey – The Greatest Story Ever Told who is safe vaccine advocate and researcher and radio producer, Cynthia Janak a Journalist who campaigns for Gardasil and Cervarix victims on her website Only The Truth and and who writes for Renew America and Dr Judi Gurstung

// According to Dr Moulden, micro-vascular strokes from vaccinations cause Autism, ADHD, Sudden Infant Death, (SIDS), Gardasil & Anthrax (Gulf War Syndrome) adverse reactions, specific learning disabilities, seizures and more. To find out about all this and more tune in.

All Governments and anyone daring to proclaim that vaccines are safe should listen to what he says because this man is very very powerful indeed. In a news article just released, called Vaccines used in children causing brain damage he explained how with the use of before and after photographs of children he can prove 100% that children have had brain damage from the MMR.

This evidence was used in the Ben Zeller case. Ben Zeller, says his son, Ben, was a normal 11-month-old when he received the MMR.

Within days, he had a seizure. The seizure was so severe that it left Ben with permanent brain damage.

Mr Zeller had always believed that Ben’s fit was a reaction to the MMR. Ben was a healthy and happy child into everything After the vaccine he was left with severe brain damage.

Zeller was one of the first to prove his case in the Federal Vaccine Court. Last July, the court ruled his son would not have experienced the seizure if it weren’t for the MMR vaccine.

Dr Moulden said “We have thousands of cases and we can show all vaccines are causing the exact same problem,”

The above article quotes :-

“Moulden is spending the next week in South Florida interviewing families like the Zeller’s.

Moulden has gathered more than five thousand images of children’s faces taken before and after the MMR vaccine to help prove his case.The photos highlight children’s eyes turning in and out as well as the corner of their mouth dropping.

“These are classic signs of a stroke and clearly a direct result of vaccines,” Moulden said.

Still, many doctors and Health Departments say shots are not only safe but needed.”

Obviously the Ben Zeller case and Dr Moulden’s brilliant research and factual evidence that vaccines can cause brain damage have not yet reached the UK Government because Dawn Primarolo the UK Health Minister is so convinced or as some say ‘brainwashed’ that vaccines are 100% safe that she is breaking the promises made by the UK Government and via the JCVI is moving towards making vaccines compulsory in UK for all citizens including children. The Child Health Safety website reported the full story .

All in all the evidence that vaccines do cause some children to have severe reactions is mounting and Governments who collude with the drug companies and crooked committees who have members who sit in meetings discussing serious adverse reactions, including cot death and then go into courts as expert witnesses and say mothers have killed their children and adverse reactions to vaccines could not have played a part in their child’s death and other members who have links to drug companies should take note. The public are not thick and through the Internet now have access to the truth.

The question “Do vaccines cause brain damage?” finally answered

Neurological Vaccine Damage Explained by Dr. Andrew Moulden

Pathological processes have been clinically silent — until now
May 26, 2009, Fort Collins, CO. Canadian physician, Dr. Andrew Moulden BA, MA, MD, PhD, and leader of the Canadian Action Party will join radio talk show host, Leslie Botha, safe vaccine advocate and researcher, Cynthia Janak and Dr. Judi Gerstung on Holy Hormones Honey the Greatest Story Never Told! on community radio, KRFC FM 88.9, Monday, June 1 from 6 to 7 pm MST. The show will be audio streamed via the KRFC web site.

For the past seven months, the popular talk show has focused on the dangers of Gardasil, Childhood Immunizations and the Anthrax vaccine that has been linked to the Gulf War syndrome. The hosts have interviewed parents, and medical experts as they strive to share information about the dangerous and toxic adjuvants that are used in the vaccine serums as preservatives and additives. After months of research and combing FDA, CDC and myriads of pharmaceutical documents, Janak and Botha discussed the link between vaccines with toxic compounds, and neurological damage. In February, on a show titled: “Gardasil Girls Give the Silent Faces of Autism a Voice,” and with documentation in hand, they announced that the Gardasil vaccine and childhood immunizations were responsible for brain damage.

On June 1, Dr. Andrew Moulden, whose expertise is in neurobehavioral assessments of acquired brain and behavioral disorders, will be addressing how vaccines cause micro-strokes that result in neurological damage to those with adverse vaccine reactions. Dr. Moulden has chosen to devote his career to neurobehavioral and neurocognitive assessments and research based upon his PhD and Masters training rather than practicing clinical medicine. For the past several years Dr. Moulden has devoted his work to deciphering neurobehavioral sequelae associated with immune system hyper stimulation, neurodevelopmental disorders, “and ultimately to vaccinations as the common environmental trigger for several brain and behavioral disorders.”

Dr. Moulden has just released a DVD series titled: Tolerance Lost, proving “in medical physiology and clinical sciences, by using new and old diagnostic technologies, that all vaccinations cause immediate and delayed, acute and chronic, permanent and transient, disease and disorders that cut across all organ systems.” According to Moulden, damaged tissues are the result of impaired blood flow and blood “sludging” in the microscopic vessels of the circulatory system. Autism, ADHD, Sudden Infant Death Syndrome (SIDS), Anthrax (Gulf War Syndrome) Gardasil adverse reactions, specific learning disabilities, seizures and more are caused by the impaired blood flow — specifically to the brain.

Dr. Moulden stresses that “all vaccinations are causing the same neurological damages as wild polio and other ‘vaccine preventable pathogens did in the past — albeit in an attenuated form. It is not the germs/toxins that are causing damage; it is the body’s non-specific response to foreign substances entering it. All vaccinations are ‘foreign substances.’ Repeat vaccinations serially aggravate the underlying mechanisms of injury.”

Now, with Dr. Moulden’s expertise, lay people and practitioners will now be able to see the neurological damages, in real time, or retrospectively, in most that have been injured or who have died — whether or not they recognized at the time that injury/death was vaccine induced. The range of impairment -common to all vaccinations — is from clinically silent to terminal, (life ending) with the entire gamut of neurocogntive, neuropscyhiatric, and neuroimmunological derailments existing along a continuum of harm and end organ diagnostic labels…. including the proverbial “cause of death unknown.”

The June 1 radio show will be a groundbreaking event because the question, “do vaccines cause brain damage?” will finally be answered.

© Cynthia A. Janak

Gardasil Linked To Deaths Of 32 Young Girls

32 Girls Have Died
11,916 adverse events already reported to the CDC… and counting.
Pain and swelling. Life-threatening muscle weakness. Blood clots in the heart and lungs.
And the deaths of 32 innocent girls and young women.
You might think I’m talking about a deadly new disease or a global epidemic…
I’m not.
Sadly, it’s more sinister than that. The health threats listed above have all been linked with Gardasil, the so-called “cervical cancer vaccine.” And thanks to Pharma giant Merck, desperate parents and naive young women believe this vaccine saves lives… they couldn’t be more wrong.
That’s why HSI’s Jenny Thompson has released a new video in which she exposes the deception for what it is…and reveals some truly shocking information no one else is talking about.
And you are the very first to see it.
Please, if you have daughters, granddaughters or friends who might be considering this terrible vaccine, you must watch this video. And please forward it to anyone you think would benefit from the vital information it contains.
If you think you know the whole story on Gardasil, I think you’ll be shocked by what you’re about to see. <>Just click here to start watching the video. It’s just a few minutes long… and those few minutes might just save a young girl’s life.
–MaryEllen Tribby
CEO & Publisher, Early to Rise