February 2007 Archives

COPENHAGEN (AFX) - Danish pharmaceutical group ALK Abello AS said its tablet-based grass pollen vaccine Grazax showed very positive results for the second treatment year in the ongoing GRAZAX GT-08 study.

In the second treatment year, Grazax reduces hay fever symptoms by 44 pct and reduces the need for symptom-relieving medication by 73 pct compared with placebo, ALK Abello said.

ALK Abello said it has recently entered strategic alliances for the Grazax programme with the Menarini Group for some European markets and with Schering-Plough (nyse: SGP - news - people ) for North America..

Copyright AFX News

ISLAMABAD, 27 February 2007 (IRIN) - Muslim and community leaders are seeking to counter the disinformation surrounding polio vaccinations in parts of Pakistan's North West Frontier Province (NWFP) and tribal areas.

"To make people understand the importance of polio immunisation in an Islamic context is extremely important. We are engaging moderate religious leaders, community leaders and influential tribal elders. And we are holding community jirgas [councils] to address the concerns of the parents and ensure their children are vaccinated," said Melissa Corkum, a spokesperson for the United Nations Children's Fund (UNICEF) in the Pakistani capital, Islamabad.

The message is "that the polio vaccine is safe and that the same vaccine has been used to eradicate polio in other Muslim countries like Saudi Arabia and Indonesia", Corkum said. 

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.

Merck & Co., Inc. today updated the prescribing information for ROTATEQ® (rotavirus vaccine, live, oral pentavalent), the Company's vaccine to help prevent rotavirus gastroenteritis in infants and children. The labeling update includes post-marketing reports of intussusception and hematochezia to the Vaccine Adverse Events Reporting System (VAERS), a national vaccine safety surveillance program.

A naturally occurring event in infants, intussusception is estimated to occur in the U.S. in approximately 1 in 2,000 infants during the first year of life. Cases of intussusception can occur when no vaccine has been given and the cause is usually unknown. Today, the U.S. Food and Drug Administration (FDA) reported that since the licensure of ROTATEQ on Feb. 3, 2006 until Jan. 31, 2007, 28 cases of intussusception in infants who received ROTATEQ have been reported in the U.S. to VAERS and that this number does not exceed the number of cases expected based on the background rate. The FDA Public Health Notification on this label change is available at http://www.fda.gov/cber/safety/phnrota021307.htm.

Atlanta, GA -- The Advisory Committee on Immunization Practices (ACIP) will meet tomorrow at the CDC in Atlanta. Thimerosal, a controversial mercury- based vaccine preservative still used in flu shots, will be discussed. Health Reporters are encouraged to attend. Lyn Redwood of the National Autism Association and the Coalition for SafeMinds will be in attendance and available to speak with members of the press.

WHAT:
The Advisory Committee on Immunization Practices (ACIP) Meeting

WHEN:
Tomorrow, February 21st and Thursday, February 22nd from 7:00a.m.-6:00p.m.
Ethylmercury Thimerosal is scheduled to be discussed tomorrow at 10:55 am. 

The new initiative was announced today by the Government of Canada and the Bill & Melinda Gates Foundation to contribute to global efforts to develop HIV vaccines.

Developing a safe and effective vaccine to protect people against HIV is one of the most important goals in public health. The world has already lost tens of millions of lives to this virus and we must do everything we can to prevent future deaths.

The new Canadian HIV Vaccine Initiative partnership will make a significant contribution to this effort through the Global HIV Vaccine Enterprise, established through the efforts of the G8 countries.

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.

Washington, D.C. - The National Vaccine Information Center (NVIC) today released a new analysis of the federal Vaccine Adverse Event Reporting System (VAERS) reports of serious health problems following HPV vaccination (Merck's GARDASIL) during the last six months of 2006. Out of the 385 individual GARDASIL adverse event reports made to VAERS, two-thirds required additional medical care and about one-third of all reports were for children 16-years-old and under, with nearly 25 percent of those children having received simultaneously one or more of the 18 vaccines that Merck did not study in combination with GARDASIL. NVIC is calling on the FDA and CDC to warn parents and doctors that GARDASIL should not be combined with other vaccines and that young girls should be monitored for at least 24 hours for syncopal (collapse/fainting) episodes that can be accompanied by seizure activity, as well as symptoms of tingling, numbness and loss of sensation in the fingers and limbs, all of which should be reported to VAERS immediately.

The Wits University has launched an HIV vaccine trial site at Mkhuhlu in Mpumalanga. The launch was attended by Nozizwe Madlala-Routledge, the deputy minister of the department of health and Derek Hanekom, the deputy minister of the department of science and technology.

This trial site is the first to be established in a rural area in the country. The four other HIV vaccine sites are in urban areas including Soweto, Cape Town, Pretoria and Klerskdorp. Steve Pollman, a professor at Wits University says the HIV vaccine trial site is expected to start functioning in July. He says there will be more than one HIV vaccine to be tested. The vaccine trials are expected to last for three years.

LAS GUARANAS, Dominican Republic - Leaving her tin-roofed brothel for the day, the 42-year-old prostitute journeys to the capital for an injection that might save not only her life, but possibly millions more around the world.

Jacinta Julia Adams Fernández, a mother of three, is one of 175 Dominican prostitutes lending their bodies to a trial of what New Jersey-based Merck & Co. hopes will prove to be a vaccine against the virus that causes AIDS.

Since turning to prostitution after a divorce 13 years ago, Adams has seen friends and co-workers die from the disease. Prostitution is illegal but widespread, largely ignored by the authorities.

CANBERRA, Australia, Feb. 14 (UPI) -- An Australian epidemiologist wants the meningococcal vaccine studied noting the bacterial infection is affecting more people than it did 20 years ago.

Mahomed Patel of Australian National University also called for an analysis of historical patterns of meningococcal incidence to better understand, and further prevent meningitis.

"The meningococcal vaccine has been effective since its introduction in 2003, but the disease incidence rate is still higher than 20 years ago," he said. "We could do better."

By ANDREW BRIDGES Associated Press Writer
© 2007 The Associated Press

WASHINGTON — The government of USA warned on Tuesday of potentially life-threatening twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea.

The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago.

The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases. The condition also can occur spontaneously. Indeed, the reports don't exceed the numbers expected to occur naturally each year - the so-called background rate, the FDA said.

Feb. 9, 2007 -- An AIDS vaccine that uses a genetically engineered smallpox virus to boost anti-HIV immunity looks promising in early tests on humans.

In animal tests, the vaccine did not protect monkeys against infection with an AIDS virus. But vaccinated animals remained healthy -- and suffered no immune damage from the deadly virus.

Now, nine humans have received small doses of the vaccine: about one-tenth of the full dose. The vaccine was safe. And even at this tiny dose, it stimulated the kind of immune responses that protected monkeys.

The vaccine is the brainchild of Harriet Robinson, MD, chief of microbiology and immunology at Yerkes National Primate Research Center. Robinson is chief scientific advisor to GeoVax Labs Inc. of Atlanta, spun off from Emory University's vaccine center to market the vaccine.

The debate in the USA over the use of Merck & Co's cervical cancer vaccine Gardasil is reaching boiling point after the Governor of Texas announced plans for mandatory vaccination programmes for girls aged 11 and 12.

Republican Governor Rick Perry last week chose to employ an executive order, thus bypassing any opposition in the legislature, which makes Texas the first state to require that girls receive the human papillomavirus vaccine that causes cervical cancer before they can enter the sixth grade at school, beginning September 2008. The order does not specifically mention Gardasil but Merck's vaccine is the only HPV treatment on the market at the moment, although GlaxoSmithKline's Cervarix is expected to be filed for approval in the USA by April.

A large-scale HIV vaccine trial has begun in South Africa.

The trial, the largest clinical trial to date, will see 3,000 HIV-negative men and women receive a vaccine containing copies of three HIV genes. Volunteers will not receive the full copy of the HIV virus, making it impossible to be infected in the trial.

Previous trials of the vaccine found it to be safe in stimulating cellular immune responses against HIV.

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.

He just proposed legislation based on American Cancer Society recommendations that females as young as nine be vaccinated against HPV, which disproportionately affects minority communities.

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%)
  

New Delhi, Feb 4 (IANS) India is on the threshold of launching an oral vaccine for diabetes that would replace the current practice of insulin injections, promising relief to millions in the country suffering from the debilitating health condition.

The Andhra Pradesh-based pharmaceutical company Transgene Biotek Ltd is currently doing research and pre-clinical trials of the vaccine in collaboration with the Indian Institute of Chemical Technology (IICT), Hyderabad.

"We have made considerable progress in the drug development process. The new vaccine will be administered in liquid form," Prakash V. Diwan, chief of pharmacology of IICT, told IANS.

The word "cancer" triggers emotions ranging from fear to empathy to panic. But we cannot let our emotions cause us to spend money or create mandates without careful research. We need to evaluate claims of drugmakers, lobbyists and lawmakers when they seek money for cancer prevention efforts.

Here are 10 reasons why we are skeptical about efforts to mandate for school girls the HPV vaccine against the sexually transmitted cervical-cancer virus.

10. Merck and Co. (the manufacturer of the vaccine) has funneled money through Women in Government, an advocacy group made up of female state legislators around the country.

The International AIDS Vaccine Initiative's (IAVI) January 2007 Annual Issue of VAX, an editorially independent bulletin on AIDS vaccine research published by IAVI, reports that 13 new preventive AIDS vaccine trials were initiated in eight countries around the world in 2006. There are now more than 30 trials ongoing in 24 countries, across every continent.

This annual publication provides the only comprehensive listing of all AIDS vaccine clinical trial activity worldwide.

ALLERGY sufferers could bid farewell to their sneezes with a new generation of vaccines that take effect within weeks.

Existing vaccines for allergies involve three to five years of regular injections with increasing amounts of allergen - the substance that triggers an allergy. All the while the immune response slowly changes from a predominance of T-helper 2 (TH2) cells, immune cells responsible for triggering allergic reactions, to T-helper 1 (TH1) cells, which stimulate the production of protective antibodies.

Because nothing is directing allergens to the right place in immune cells, it takes a lot of allergen to generate a response.

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.