Vaccination News

TORONTO, September 20, 2007 (LifeSiteNews.com) - As Canada, in large part due to aggressive behind the scenes lobbying, rolls out the not-comprehensively-tested Merck HPV vaccine for girls as young as nine, a look at developments on the vaccine south of the border should cause Canadians serious concern.  In the United States a similar lobby campaign by the same company launched the mass HPV vaccination of girls beginning in June last year.  

In just little over a year, the HPV vaccine has been associated with at least five deaths, not to mention thousands of reports of adverse effects, hundreds deemed serious, and many that required hospitalization.

AUSTIN — The Senate Monday passed a bill overturning Gov. Rick Perry's order that middle-school girls be vaccinated against a sexually transmitted virus linked to cervical cancer, with a requirement that the issue be reviewed in four years.

After a brief debate, the Senate voted 30-1, with Sen. Leticia Van de Putte, D-San Antonio, casting the lone "no" vote.

The bill would prevent the HPV vaccine from being required for school enrollment until 2011. The version passed by the House has no expiration date.

As the first FDA-approved cancer vaccine, designed to protect against human papillomavirus, has moved from scientific discussion to social debate, other vaccine studies are continuing to make progress. While HPV vaccine efforts had the "benefit" of a viral source for the disease, other researchers are developing vaccines for cancers that are not virally based, in an effort to coax the immune system into attacking cancerous cells.

At the 2007 Annual Meeting of the American Association for Cancer Research, presentations on ongoing HPV trials and other new approaches to stimulating the immune system are injecting momentum into cancer vaccine research.

A vaccine against the sexually transmitted virus that can cause cervical cancer went on sale Wednesday in Italy, the first European Union nation to offer the vaccine free for 12-year-old girls, the Italian Health Ministry said.

The ministry said a campaign will be launched soon to encourage the free vaccination of 12-year-olds but that the vaccine for the human papillomavirus, of HPV, will not be mandatory. Older girls and women who want the vaccination will have to pay for it.

Proponents of the vaccine say it will be most effective when given before girls become sexually active. Ministry officials said the vaccine is being supplied by Sanofi-Pasteur, the vaccine division of Sanofi-Aventis.

By Maggie Mahar

February 22, 2007 - Yesterday, Merck announced that it is no longer going to try to persuade states to make its new $360 cervical cancer vaccine mandatory for all pre-teens. (At least, not publicly). The company wouldn’t divulge how much it has spent, to date, on its lobbying campaign.

Virtually everyone has heard about “Gardasil.” Planned Parenthood backs it. Women in Government extols its virtues. (Both organizations receive significant contributions from Merck). Not long ago, a glowing New York Times editorial congratulated Texas governor Rick Perry for mandating “A Vaccine To  Save Women’s Lives.”( So far as I know, Merck makes no contributions to The New York Times, but Perry’s former chief of staff is a Merck lobbyist.) At this point, twenty states have drafted plans to follow Perry’s example.

Genital warts. Cervical cancer. Vaginal disease. All these afflictions are caused by the human papillomavirus. Recently, women have had an opportunity to decrease their chances of contracting the virus as a result of the new three-dose vaccine from Merck & Co. Inc. called Gardasil.

In recent news, however, the adequacy of the warning label provided by the Center for Disease Control has been tested by the public, as numerous complaints of side effects have surfaced after patients received their HPV vaccinations.

As of now, a report has stated that over 500 people have complained of post-vaccination side effects such as fainting and dizziness, and there have been three recorded cases of the Guillain-Barré syndrome. According to health professionals, the syndrome is a rare disorder within the nervous system that sometimes causes complete paralysis.

Drug development company Advaxis, has created a family of vaccines, Lovaxin, which encourages the immune system to attack cancer in the same way it would a flu vaccine.

Dr. Vafa Shahabi, Advaxis' Director of Research and Development, reports that because the human immune system is not designed to fight cancer on its own, she and her colleagues are trying to harness its power through a new kind of life form: specifically a family of vaccines, which they call Lovaxin. The vaccines are comprised of new strains of bacteria created in Advaxis' laboratory that are programmed to kill off specific cancers.

Central to this startling discovery is the microbe Listeria monocytogenes, a common bacterium found in milk, cheese and other dairy products. This microorganism apparently aids in fighting cancer by activating the body's own killer (cytotoxic T) cells to elicit a stronger than normal immune response to the presence of cancer cells. The vaccines "teach" the immune system to mount a specialized, targeted response that is lethal to cancer.

Pediatricians, gynecologists and even health insurers all call Gardasil, the first vaccine to prevent cervical cancer, a big medical advance.

But medical groups, politicians and parents began rebelling after disclosure of a behind-the-scenes lobbying campaign by Gardasil's maker, Merck & Co., to get state legislatures to require 11- and 12-year-old girls to get the three-dose vaccine as a requirement for school attendance.

Some parents' groups and doctors particularly objected because the vaccine protects against a sexually transmitted disease, human papilloma virus, which causes cervical cancer. Vaccines mandated for school attendance usually are for diseases easily spread through casual contact, such as measles and mumps.

Medical advancements, parental concerns, government clout and the powerful drug industry are facing off in what promises to be vigorous nationwide debate over vaccination of young girls against the sexually transmitted human papillomarivus virus, often a precusor to cervical cancer.

Sen. Richard T. Moore (D-Uxbridge), co-chairman of the Massachusetts Joint Committee on Health Care Financing, would like to see administration of the HPV vaccine Gardasil to sixth-grade girls become requisite to school attendance, much like shots for other childhood illnesses.

This is a quote from a post on Mothering.comn forums:

FROM THE CDC:

• Most women who develop invasive cervical cancer have not had regular cervical cancer screening.
• Cervical cancer is an uncommon consequence of HPV infection in women, especially if they are screened for cancer regularly with Pap tests and have appropriate follow-up of abnormalities.
• But over the last 40 years, widespread cervical cancer screening using the Pap test and treatment of pre-cancerous cervical abnormalities have resulted in a marked reduction in the incidence of and mortality due to cervical cancer in the U.S. (70%)
  

An interesting opinion from Canada.

As a father of three daughters I have certainly taken notice of the announcement and promotion of a vaccine to treat the human papilloma virus. This virus has a strong connection to and may be the largest factor in the cause of cervical cancer.

Statistically, most women will become infected in their lifetime, 80 percent by some estimates.

But there is preliminary talk of making this vaccination mandatory for our school-aged daughters in the 11- to 16-year-old bracket. I'm afraid I must protest.

After parents complained the inoculations were inappropriate for such young girls, the government abandoned its proposal, but there are still plans to vaccinate 12-year-old girls against the disease, which is drawing continued fire from parents and advocacy groups. Some opponents say immunizing girls against HPV might encourage them to start having sex at a younger age.

HPV can cause genital warts and is thought to be the root cause of around 70 percent of cervical cancer cases. In Scotland alone, more than 500 women are diagnosed with the virus annually, and about 100 of them die.

COPENHAGEN, Jan 3 (Reuters) - Danish vaccine maker Bavarian Nordic (BAVA.CO) said on Wednesday that its U.S. subsidiary BN ImmunoTherapeutics received approval from the U.S. Food and Drug Administration (FDA) to start clinical trials with the breast cancer vaccine MVA-BN-HER-2.

Patient enrolment in a Phase I/II study in the United States will start as soon as possible, Bavarian said.

BN ImmunoTherapeutics also plans to start a Phase I/II study with the vaccine in Europe.

A study has found that men with advanced, often untreatable prostate cancer who received a therapeutic cancer vaccine went on to survive longer than those receiving a placebo.
Study findings showed the vaccine group lived up to an average of four-and-a-half months longer and had a greater than three-fold increase in survival at 36 months when compared to patients in the placebo group.

The study is published in the Journal of Clinical Oncology.

The double-blind, placebo-controlled phase III clinical trial was conducted to test the efficacy of the vaccine, called sipuleucel-T, in delaying disease progression and prolonging survival in patients with asymptomatic metastatic hormone refractory prostate cancer (HRPC).

by Michael N. Westley

A vaccine that prevents the spread of the human papillomavirus (HPV) has been approved for women and promises to decrease the risk of cervical cancer.

But in the face of such an exciting announcement, one question remains: What about the guys?

Of course, men don't have cervixes, but they do contract and spread HPV, which can cause genital warts and in some cases, rectal cancer. Research also has shown that men are excellent carriers of the strain of HPV that causes cancer in women without developing any symptoms themselves.

The good news is that a vaccine for men may not be too far away, according to a Utah researcher.

Legislation that would urge young girls to receive a vaccine to fight cervical cancer hit a red light. The bill passed easily in the senate, but did not pass in the state house.

Concerns about the vaccine's long-term effects hindered the bill's ability to gain enough support with lawmakers.

However, the Food and Drug Administration did approve the vaccination for use in girls as young as nine years old.

source - WLNS 

By Ed Susman SAN ANTONIO, TX -- December 15, 2006 -- A experimental breast cancer vaccine appeared to offer protection against recurrences but failed to achieve statistical significance after 2 years of treatment, doctors reported here at the 29th San Antonio Breast Cancer Symposium (SABCS).

"Recurrence rates reached 8.3% among the 101 women who received the vaccine and 16% among the 85 women who acted as controls in the trial," said Col. George Peoples, a surgeon at Brooke Army Medical Center, Fort Sam Houston, Texas.

Despite the nearly 50% reduction in recurrence, the small numbers of women in the trial resulted in a statistical value that is above the cutoff generally recognized as being significant.

James Colgrove, Ph.D., M.P.H.

On September 12, 2006, 3 months after the Food and Drug Administrationlicensed a vaccine against human papillomavirus (HPV), Michiganlawmakers became the first in the United States to propose thatvaccination be compulsory for girls entering sixth grade. Parentswho objected would be able to opt out of the requirement underthe same provisions that apply to other vaccinations. The billpassed the state senate by an overwhelming margin a week laterand awaits consideration by the house. Other states are likelyto follow Michigan's lead.

The development of Gardasil, Merck's HPV vaccine, is of majorpublic health importance. The vaccine protects against fourstrains of HPV, the most common sexually transmitted diseasein the United States, including the two strains that cause mostcases of cervical cancer. More than 6 million people in thiscountry become infected with HPV every year, and nearly 10,000 women are diagnosed with cervical cancer. Because the vaccinehas the greatest benefit when it is given before a person becomessexually active, the Advisory Committee on Immunization Practicesof the Centers for Disease Control and Prevention recommendedthat it be given routinely to girls at 11 or 12 years of age;it is not yet approved for use in boys. The committee took noposition on whether vaccination should be required by law; suchpolicy decisions are made by individual states.

The World Today (interview)
Reporter: Gillian Bradford

ELEANOR HALL: After weeks of toing and froing, the Federal Government has announced it will now fund the cervical cancer vaccine, Gardasil, from next year.

Health Minister Tony Abbott initially said the vaccine couldn't be available until at least 2008, but under pressure from the Coalition's own backbench, the Prime Minister intervened to force a faster process.

The vaccine will be targeted at 12 and 13-year-old school girls and the Health Minister Tony Abbott says the Government has extracted the best price from the drug manufacturer after weeks of negotiation.

PHILADELPHIA, Nov. 29 (UPI) -- U.S. firm AVAX Technologies said Wednesday it is cleared to launch a phase 3 study of its metastatic melanoma vaccine, M-Vax.

The trial will enroll as many as 387 patients with stage IV melanoma at sites in the United States, Europe and Australia. Patients will be randomized in a 2-1 ratio to receive either M-Vax or placebo.

The study will measure best overall anti-tumor response rate and the percentage of patients surviving two years, AVAX said.

ImmunoCellular Therapeutics, Ltd., which was formerly known as Optical Molecular Imaging, Inc. ("ICT"), announced today that it has entered into an exclusive, worldwide license agreement with Cedars-Sinai Medical Center covering Cedars-Sinai's technology for cellular therapies, including dendritic cell-based vaccines for brain tumors and other cancers, as well as other neurodegenerative disorders. The technology is covered by patent applications that have been filed in the United States.

Dendritic cell-based vaccines may bolster the body's natural tendency to defend itself against various forms of cancer. ICT's first product candidate will be a vaccine for treating malignant brain tumors. The high rate of mortality of patients diagnosed with brain cancers and in particular with glioblastoma multiforme (the most lethal form) is driving the scientific community to develop improved treatments to increase the survival time and enhance the quality of life of patients. More than 17,000 cases of glioblastoma are diagnosed each year in the United States. There currently is no satisfactory treatment and two-year survival rates are only in the range of 26%.

THE cervical cancer vaccine being held out as an alternative to Gardasil may offer much longer-lasting protection, according to its maker.

Drug giant GlaxoSmithKline, which is trying to stop the Government agreeing to a vaccination program using only Gardasil, says its treatment, Cervarix, has the strength to protect women vaccinated at school until they turn 55.

Washington, Nov. 17 (ANI): A vaccine for treating a recurrent cancer of the central nervous system that occurs primarily in the brain, known as glioma, may activate a tumour-specific immune response in the body, reveals preliminary data from a clinical trial at UCSF Medical Centre.

Tests conducted on the first group of six patients at the UCSF Brain Tumour Research Centre show that vitespen, a vaccine made from the patient's own tumour, was associated with tumour-specific immune response in patients with recurrent, high-grade glioma.

Glioma is a type of primary tumour that arises from the glial cells, the connective tissue cells that surround and support nerve cells. The most common site of involvement of a glioma is the brain. Malignant glioma is currently a fatal disease.

British researchers have developed a vaccine that stimulates the body’s immune system to fight off cancerous cells.

In a clinical trial of 67 colorectal cancer patients, University of Nottingham scientists found that when the vaccines were administered before and after tumour removal surgery, immune cell production increased in 70 per cent of the volunteers.
 
"This is the first vaccine shown to stimulate TNF-alpha – an immune-system protein that is very effective at killing cancer cells," said Lindy Durrant, senior author of the study and professor of cancer immunotherapy at the university.

Drug company CSL will today cut its asking price for cervical cancer vaccine Gardasil in a renewed bid to secure public subsidies.

CSL chief executive Brian McNamee has cut short a trip to the US to attend a meeting with Department of Health officials in the hope of reversing last week's rejection of the vaccine's listing on the pharmaceutical benefits scheme.

The vaccine, developed by Australian of the Year Ian Frazer, protects women against cervical cancer.

source - The Australian News

The findings, announced yesterday at a conference in Prague, suggest the possibility of developing embryonic stem-cell vaccines that prevent cancers in humans.

Gardasil got rejected a subsidy in Australia due to the high cost of the vaccine. However today the australian Prime Minister voiced his wish to change that decision. In other words, the australian taxpayers will ensure the profit of pharmaceutical corporation. Right?

Here is an interview transcript from The World Today:

ELEANOR HALL: The Prime Minister John Howard has now declared that a new vaccine for cervical cancer will be subsidised, despite the Pharmaceutical Benefits Advisory Committee recommending against it.

Mr Howard says the Government will provide funding for the vaccine, it's just a question of when. The Prime Minister was responding to widespread outrage this morning from doctors and from some members of his own backbench, as Lynn Bell reports from Canberra.

AUSTRALIA - A world-first vaccine that prevents 70 per cent of cervical cancers has been knocked back from the national immunisation program, Labor said today.

The government's pharmaceutical advisory body today rejected an application from Australian manufacturer CSL to have the vaccine Gardasil available free to all females aged 12 to 26.

Australian-designed Gardasil halts the spread of sexually-transmitted human papilloma virus (HPV), which causes 70 per cent of cervical cancer.

An Australian company is in a global race to produce a vaccine for diseases such as HIV and cancer.

The privately-owned company Replikun Biotech Pty Ltd has used the kunjin virus, found in mosquitoes from the wet tropics region of north Queensland, to make an injectable vaccine after processing with gene technology.

Replikun Biotech says laboratory testing has yielded promising results and the company has now reached the stage where the vaccine could be tested on monkeys, and if that is successful, on humans.

Replikun Biotech chief executive Shane Storey said the class of vaccines under development activated parts of the immune system which conventional vaccines could not kick-start.

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced that the U.S. Centers for Disease Control and Prevention (CDC) has added Merck’s cervical cancer vaccine, GARDASIL^® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] to the CDC’s Vaccines for Children (VFC) contract for girls and women aged 9 to 18. GARDASIL was approved on June 8 by the Food and Drug Administration (FDA) for use in girls and women ages 9 to 26 years. GARDASIL is the world’s first and only vaccine available for the prevention of HPV types 16- and 18-related cervical cancer, cervical pre-cancers (CIN 2/3 and AIS), vulvar pre-cancers (VIN 2/3) and vaginal pre-cancers (VaIN 2/3) and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18.

"The addition of GARDASIL to the VFC program is a very positive step towards protecting the future health of girls and young women in this country against cervical cancer caused by HPV types 16 and 18," said Mark Feinberg, M.D., Ph.D., vice president, Policy, Public Health and Medical Affairs in the Merck Vaccine Division. "Inclusion of GARDASIL in the VFC program, coupled with private insurance coverage and Merck's Vaccine Patient Assistance Program, represent important means to facilitate broad and equitable access to GARDASIL."

TAMPA, FL -- October 20, 2006 -- The search for effective anti-cancer therapies increasingly leads medical scientists to immune-based agents like anti-vaccines, or a "personalized" approach based on a patient's unique disease status. A new study reported by Tampa-based Accentia Biopharmaceuticals, achieves promising treatment objectives by exploiting both therapeutic approaches simultaneously.

Results from an ongoing clinical trial suggest that patients with non-Hodgkins lymphoma (NHL), a cancer of the lymphatic system, can benefit from treatment with a novel anti-cancer vaccine based on the patient's specific tumor. The study results, published September 20 in the prestigious Journal of the National Cancer Institute, demonstrated that administration of the BiovaxID™ anti-cancer vaccine formulation resulted in long-lasting remission in NHL patients.