Boston Trial to Test New HIV/AIDS Vaccine

(HealthDay News) -- A new HIV/AIDS vaccine designed to overcome the problem of preexisting immunity to common vaccine vectors is being tested in an early clinical trial at Brigham and Women's Hospital in Boston.

Preexisting immunity is believed to be a major problem in developing nations.

There will be 48 healthy volunteers taking part in the trial of the vaccine, which consists of a replication-incompetent, recombinant adenovirus serotype 26 (rAd26) vector encoding an HIV-1 envelope gene.

Each volunteer will receive either two or three immunizations, and then be monitored to assess the safety of the vaccine and its ability to trigger an immune response.

The rAd26 vaccine was developed by the Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program, sponsored by the U.S. National Institute of Allergy and Infectious Diseases. The program brings together academic and industry researchers to accelerate development of promising HIV/AIDS vaccine candidates.

The vaccine, the first HIV-1 vaccine candidate to emerge from the IPCAVD program, is made by Dutch biotechnology company Crucell Holland B.V.

The approach used in developing the rAd26 vaccine enables researchers to circumvent preexisting immunity to serotype 5, the virus responsible for the common cold. This virus has recently shown limitations as an HIV-1 vaccine vector.

"The rAd26 vector does not regularly occur in the human population, and human antibodies to this vector are rare. The rAd26 vector therefore is efficacious in eliciting good T and B (immune) cell responses," Jaap Goudsmit, chief scientific officer at Crucell, said in a prepared statement.

About 33.2 million people worldwide are living with HIV/AIDS, and there were 2.7 million new infections reported in 2007.

More information
Currently, there is no vaccine to protect against HIV/AIDS. The American Academy of Family Physicians offers tips for preventing HIV infection.

Eating Less May Hinder Immune System

(HealthDay News) -- You may no longer need to remember whether it's "starve a cold, feed a fever" or vice versa. New research suggests you should just eat.

A study of deer mice has found that reducing the amount of food the mice ate impaired their immune system. The findings are published in the May/June issue of Physiological and Biochemical Zoology.

The researchers found that decreasing the amount of food the mice ate by 30 percent significantly decreased the number of B cells in their systems. B cells produce antibodies and maintain immune memory, so an immune system lacking B cells must relearn how to fight infection and disease.

"A 30 percent restriction in food intake doesn't affect body mass and only minimally reduces activity in deer mice, but it eliminates the long-term immune protection provided by antibodies," study co-author Lynn Martin said in a prepared statement. "One wonders whether similar moderate food restriction has comparable immune effects in humans."

Martin and fellow researchers cited previous studies that had found that infections were "more frequent and tend to be chronic in malnourished children." Previous studies have also found that vaccines that provoke B cells to protect the body long-term, such as the vaccine for measles, are less effective among the malnourished.

The authors proposed that future research should be done to learn what specific features of diet (calories, protein, micronutrients) affect immune system function.

More information
The U.S. National Institute of Allergy and Infectious Diseases has more on how vaccines work.

Many States Still Fall Short in Emergency Preparedness: Report

(HealthDay News) -- Most Americans don't feel safer now than they did before 9/11, and their fears might be justified, a new report claims.

For example, seven states have not purchased antiviral medications in the event of a pandemic, 13 states don't have effective plans to distribute vaccines, antidotes and medical supplies in a public health emergency, and seven states and the District of Columbia don't have the ability to test for biological threats.

The report, compiled by the Trust for America's Health and released Tuesday, says that while many states have made progress in preparing for a potential public health disaster, much more needs to be done, and cuts in federal funding for state and local preparedness programs "threaten the nation's safety."

"Sept. 11, the anthrax attacks, Hurricane Katrina and the growing threat of a pandemic flu outbreak have all been wake-up calls to the country revealing gaps in our public health system's ability to respond to major crises," Jeffrey Levi, executive director of the trust, said during a midmorning teleconference.

Some important lessons have been learned from these events, Levi said. "Significant progress has been made in the nation's health emergency preparedness effort, but a number of areas still require serious attention."

That concern is heightened by the continual cuts in state, local and federal funding for preparedness, Levi added. "All Americans have the right to expect fundamental health protection during public health emergencies, no matter where they live," he said.

The report evaluates each state on 10 indicators of health emergency preparedness. Among the states, 35 plus Washington, D.C., scored eight or higher. Illinois, Kentucky, Nebraska, New Jersey, Pennsylvania, Tennessee and Virginia scored 10 out of 10, while Arkansas, Iowa, Mississippi, Nevada, Wisconsin and Wyoming scored the lowest, with six out of 10.

To remedy some of these problems, Levi's group is calling upon the federal government to increase public health and disaster preparedness funding. In addition, the U.S. Department of Health and Human Services should be expanding efforts to improve hospital surge capacity and community and hospital preparedness for public health emergencies, Levi said.

A public survey of more than 1,000 adults included in the report found that six years after 9/11, 54 percent of Americans believe the United States is not as safe as it was before 9/11, and two years after Hurricane Katrina, almost 60 percent of Americans do not think their community is prepared to respond to a natural disaster.

The survey also found that nine out of 10 Americans would accept a voluntary quarantine and stay home in the case of a pandemic flu. But of the 10 percent who would not adhere to a voluntary quarantine, 64 percent said they could not stay home because of lost income, and 39 percent feared losing their jobs altogether.

The report also evaluated progress by the U.S. government in preparing for bioterrorism, disasters and disease. The Pandemic and All-Hazards Preparedness Act of 2006, issuance of presidential directives, and the new Office of the Assistant Secretary for Preparedness and Response are all important steps, the report said.

However, challenges remain, including adequate funding for the Biomedical Advanced Research and Development Authority and increasing "transparency and accountability in all federally funded preparedness programs."

Other findings in the report include:

• Twenty-one states don't have laws that protect health-care volunteers from liability during emergencies.
• Twelve states don't have disease surveillance systems that work with the U.S. Centers for Disease Control and Prevention's National Electronic Disease Surveillance System.
• Another speaker focused on the lack of preparedness of U.S. hospitals to handle public health emergencies.

"To get hospitals up to speed in terms of their disaster responsibility would require an initial investment of $5 billion and about $1 billion a year to maintain that level of preparedness," Dr. Irwin Redlener, director of the National Center for Disaster Preparedness at Columbia University's Mailman School of Public Health in New York City, said during the teleconference.

The funding for hospitals, which started at $500 million dollars, has dropped to around $400 million. "It's a situation that's going in reverse," Redlener noted.

One expert thinks progress has been made, but much more is needed to maintain and improve emergency preparedness in the United States.

"The report readily captures the breadth and complexity of the many dimensions involved in emergency preparedness," said Dr. Howard Koh, director of the Harvard School of Public Health Center for Public Health Preparedness, and the former Commissioner of Public Health of Massachusetts.

Preparedness is not an endpoint but rather a process of continuous improvement, Koh said.
"By that measure, the country has made advances in planning and coordination, but there are still many areas in need of improvement. For example, the broad challenge of surge capacity, that is the need to mobilize additional staff, supplies and space in the event of an emergency, remains a major issue, especially when the health-care system is already severely stretched," he said.

Because disasters are uncommon events, there should be greater emphasis on rigorous drills and exercises that demonstrate effective coordination and mobilization of the many partners involved, Koh said.

In addition, public trust is essential, Koh said. "We need to sustain a long-term public health commitment to build an enduring system that will protect people and communities against all threats," he said.

More information
To see the full report, visit Trust for America's Health.

New Guidelines Should Improve Ovarian Cancer Detection

(HealthDay News) -- Ovarian cancer has long had a reputation as a silent killer, because many people believed it gave no warning signs until far advanced.

But women suffering from the disease knew differently. They knew they had certain symptoms that were common from patient to patient.

"Survivors for years have said there are symptoms for the disease, but no one listened to them," said Jane Langridge, chief executive officer for the National Ovarian Cancer Coalition.
Now, doctors have agreed with them.

A screening test has been developed that, in one study, accurately detected early stage ovarian cancer 57 percent of the time.

Based on that and similar studies, experts from the American Cancer Society, the Gynecologic Cancer Foundation and the Society of Gynecologic Oncologists have agreed on a set of symptoms that can be signs of early ovarian cancer.

"We want people to know it's not the silent killer. There are symptoms women can bring to their doctors that are important to pay attention to," said Dr. Linda Duska, a member of the National Ovarian Cancer Coalition's medical advisory board and a gynecologic oncologist at Massachusetts General Hospital Cancer Center, in Boston.

"This agreement is significant in the fact that, maybe if we pay more attention to symptoms, we can catch them sooner and have more success in treating them," she continued.

Early detection of ovarian cancer is crucial.

More than 22,000 U.S. women will be diagnosed with the disease this year, and three-fourths of them -- more than 15,000 -- will die from it, according to the National Cancer Institute.

If caught in the early stages, the five-year survival rate for ovarian cancer is 90 percent. But 75 percent of women are still diagnosed in the advanced stages, when the prognosis is poor.

Ovarian cancer is the eighth most common cancer among American women, not including skin cancer, according to the American Cancer Society. An estimated two-thirds of women with ovarian cancer are 55 or older.

"It is a disease that is detected in stage 3 and above, and that is unacceptable," said Sherry Salway Black, executive director of the Ovarian Cancer National Alliance and a survivor of the disease. "Our mortality figures are unacceptable."

The symptoms of ovarian cancer can be subtle and hard to assess, because they often mimic common digestive and gastrointestinal disorders. They include persistent swelling, bloating, pressure or pain in the abdomen, gastrointestinal upset, difficulty eating or feeling full quickly, and the frequent or urgent need to urinate.

Because these symptoms are so common, women should be careful not to assume the worst, Duska said.

"The goal of this is not to make everyone think they have ovarian cancer," she said. "If women have these symptoms, and they persist over time, they should have them investigated.

Everyone with bloating does not have ovarian cancer."

Typically, two or more symptoms occur simultaneously and increase in severity over time, according to the National Ovarian Cancer Coalition.

The screening test developed late last year involves an extensive checklist of symptoms and their frequency. It picked up early stage ovarian cancer 56.7 percent of the time, and late stage ovarian cancer 80 percent of the time. The test also produced "false-positive" findings 10 percent to 13 percent of the time.

The test searches for many of the symptoms agreed upon by cancer experts as indicative of ovarian cancer.

"When women go to their doctors and have had some of these symptoms, and they are new and have persisted for two or more weeks, perhaps a doctor now would be willing to perform some pretty simple tests to rule out ovarian cancer," Langridge said.

Women who have a family history of breast or ovarian cancer are at increased risk and should pay particular attention to the symptoms, Duska said.

Treatment of ovarian cancer usually involves a combination of surgery and chemotherapy.

Advances in chemotherapy have made the late-stage disease more survivable, Duska said.

In a more intensive regimen recently shown to improve survival, standard intravenous chemotherapy is combined with chemotherapy injected directly into the abdominal cavity. The abdominal injection exposes hard-to-reach cancer cells to higher levels of chemotherapy than can be reached intravenously.

"That was a breakthrough, I think," Duska said.

Other treatments being explored include new chemotherapy drugs, vaccines, gene therapy and immunotherapy, which boosts the body's own immune system to help combat cancer, according to the Mayo Clinic.

More information
To learn more about ovarian cancer, visit the U.S. National Library of Medicine.

Flu Shot Kick-Starts Fetal Immune System

(HealthDay News) -- Giving flu vaccinations to a pregnant woman kick-starts the immune system of her fetus, a U.S. study says.

The researchers, led by Rachel Miller of the Columbia University Medical Center, used a newly developed technique called MHC tetramer staining to analyze B- and T-cell immune responses in umbilical cord blood after pregnant women were vaccinated with Fluzone.

Anti-Fluzone antibodies were detected in about 40 percent of the blood cord samples. MHC tetramer staining showed that some of the blood cord samples also made T-cells specifically against the vaccine.

These and other findings in the study establish that B- and T-cell responses to antigens occur in utero after pregnant women have received flu vaccinations, the study authors said. This supports the theory that the human neonatal system can respond to environmental exposures.

The findings have important implications for determining when immune responses to environmental exposures begin, the researchers said.

The study is published in the June 1 issue of the Journal of Clinical Investigation.

Influenza vaccinations for pregnant women are considered safe and are recommended by the U.S. Centers for Disease Control and Prevention.

More information
The March of Dimes Birth Defects Foundation has more about vaccinations during pregnancy

FDA Panel Backs Prostate Cancer Vaccine

(Healthday News) -- A U.S. Food and Drug Administration advisory panel voted Thursday to support approval of Provenge, a vaccine aimed at extending survival for patients with deadly metastatic prostate cancer.

The FDA panel voted unanimously that the vaccine was "reasonably safe," noting that while it failed to meet some study endpoints, it did extend patient survival, according to published reports.

The panel then voted 13-to-4 to say there was substantial evidence to show the vaccine was effective for treating advanced prostate cancer that no longer responds to standard hormone treatment.

The FDA does not have to follow the advice of its advisory panels, but it typically does. The agency is expected to make its final decision by May 15.

Hopes have been high for the vaccine, which researchers said was the first ever shown to have an impact on cancer patients' survival. Those claims were based on a three-year study, released early in 2005, of 127 men with advanced, metastatic prostate cancer.

The trial found that patients infused with Provenge experienced an average 18 percent increase in survival, compared to those on a placebo. That worked out to 4.5 months of extra survival -- 25.9 months for those receiving Provenge vs. 22 months for those not taking the vaccine.

Provenge was developed by Seattle-based Dendreon.

"The concept behind the vaccine is to try to stimulate the patient's own immune system to recognize the prostate cancer cells and keeps them in check," said Dr. Simon Hall, a prostate cancer specialist at Mount Sinai Medical Center in New York City who worked on the trials for the vaccine.

In one phase III trial, men who had metastatic prostate cancer were three to four times more likely to be alive three years after vaccination, Hall said.

"However, the intent of that trial was not to show survival," Hall said. "The intent was to see if you could get patients to delay pain or new lesions in their bones. But they found it had no effect on that."

Before the panel met Thursday, FDA officials had expressed some reservations about the data submitted by Dendreon.

"The submitted data tend to support a finding of clinically meaningful increased survival, but doubts remain about the persuasiveness of the efficacy data," agency officials stated in documents released ahead of the meeting.

The advisory panel also noted that neither of the two studies submitted by Dendreon convincingly showed that Provenge met the primary goal of delaying progression of prostate cancer.

As reported by UPI, an increase in the frequency of "cerebrovascular accidents," such as stroke in men treated with Provenge, also "constitutes a potential safety concern," the FDA said. Stroke risk was 3.9 percent in treated patients compared to 2.6 percent in patients receiving a placebo.

Besides promising a potential benefit to men with prostate cancer, the therapy gives "proof of principle" to the idea that immune-based treatments can have a real impact on prostate cancer and other malignancies, experts said.

"There have been many failures with this kind of approach, and many have wondered if we shouldn't set the bar lower, somehow lower our expectations, and not hope for extended survival," Dr. Bruce Roth, a prostate cancer researcher at Vanderbilt University, told HealthDay when the 2005 study was released.

"But these findings are saying, 'No, looking for a survival advantage is a valid endpoint to look at for these agents,'" he said.

If caught early, prostate cancer remains very curable. However, despite advances in early detection, the disease remains the second leading cancer killer of U.S. men, according to the American Cancer Society. Even among men who develop the disease while it is still confined to the prostate, between 30 percent to 40 percent will experience a recurrence in years to come.
Because prostate cells depend heavily on testosterone to grow, therapies that reduce levels of circulating testosterone are often the first course of action in men who experience a recurrence. However, prostate cancer cells gradually grow resistant to hormonal therapy, and until very recently, doctors could only offer patients palliative therapies once that relapse occurred.
Hall said there was a new trial underway that was starting to confirm the survival results from the first study.

One advantage of the vaccine is that it has fewer side effects than chemotherapy, Hall added.
"The vaccine doesn't cure the disease, but it controls the disease for a period of time," he said. "And it is much less toxic than chemotherapy."

More information
For more on prostate cancer, head to the American Cancer Society.

Flu's Misery May Lie in the Genes

(HealthDay News) -- If the flu hits you especially hard this season, blame it on your DNA.

A new study of flu-infected mice found that certain genes spurred a strong immune response in the lungs that led to much more severe illness. Mice that didn't exhibit such an immune response were more likely to recover, the researchers found.

The findings may help humans not only survive the annual flu season but also an avian flu pandemic, should it ever arise.

"The long-term implications would fit into the idea of genetically based preventive medicine," explained co-researcher Dr. Linda Toth, associate dean of research at Southern Illinois University School of Medicine in Springfield. "To know that some people are predisposed to any kind of disease, we would be able to better advise or monitor those people so as to limit their health risk."

This knowledge might also help public health officials allocate precious resources.

"In the case of influenza, viral treatments and vaccine are in limited availability and if we had this kind of information, it could potentially be used to target the resources to those most at risk," Toth said.

She and co-researcher Rita Trammell, an assistant professor of internal medicine at Southern Illinois University School of Medicine, were expected to present the findings Friday at a meeting of the American Physiological Society, in Fort Lauderdale, Fla.

Another expert said the research has implications for the treatment of flu.

"It brings up the question of whether anti-inflammatories have a role in treating a flu with a lot of inflammation," said Dr. Marc Siegel, author of Bird Flu: Everything You Need to Know About the Next Pandemic and clinical associate professor of medicine at New York University School of Medicine in New York City. "It also brings up the question of 'Does genetics allow you to anticipate which group is going to have a more deleterious inflammatory response?' That would be very helpful epidemiologically."

The question of who dies of influenza has been a hot topic since at least the 1918 pandemic, which killed millions of people around the world. At the time, doctors noted that the immune systems of young, robust adults often "overreacted," resulting in a severe and often deadly inflammation of the lungs.

"This has been a long-time concern of scientists since 1918, when the theory was that people drowned in their own secretions," Siegel explained. "The body sees influenza and responds with a strong immunological response, and that response can lead to a lot of secretions."

The 1918 pandemic and the current avian flu -- which has so far killed only a small number of humans -- have some similarities: Both cause an intense inflammatory and immune response in the lungs of mice and people.

"With the current avian influenza as well as the influenza from the 1918 pandemic, the influenza caused a really enhanced and intense inflammatory and immune response in the lungs which killed the mice," Trammell said. "This was really important in determining why they died. We wanted to look at the background genetics of mice, how they reacted differently."

In their research, Trammell and Toth infected two strains of laboratory mice -- called Types "B" and "C" -- with an influenza A virus. Past work had shown that about half of the Type B mice would die, compared to about 10 percent of the Type C mice.

When lung tissue from the mice was examined about 30 hours after infection, the authors found that levels of all the pro-inflammatory cytokines (with one exception) were elevated and were much higher in the sensitive mice. This indicates a more severe inflammatory response, the researchers said. Cytokines are proteins that can cause inflammation when an immune response is mounted.

Despite the variation in inflammation, the level of the virus in the rodents' lungs was about the same in both groups.

A second, related study found that levels of immune-related messenger RNA (mRNA) in Type B mice were on average 24 times higher (and sometimes 100 times higher) than in uninfected mice. The mRNA levels in Type C mice increased less than three-fold after infection.

The next step?

"We want to try to identify specific genes or the array of genes that contribute to either the resistance or the severe response to the virus," Toth said. "Right now, we have some ideas, but we haven't nailed that down definitively."

Trammell said that this type of information, "would have enormous implications for understanding and avoiding the fatality associated with influenza virus."

More information

For more on avian influenza, visit the World Health Organization.

Better Treatment for HIV/AIDS?

Q: Better Treatment for HIV/AIDS?
Is there any new information with regard to diet or herbal treatments for those with HIV/AIDS that might allow discontinuation of the "cocktail" medication?

A: First of all, let me assure you that no herbal or dietary approach exists to replace treatment of HIV/AIDS with the highly effective "cocktail" of protease inhibitors and antiviral drugs. These medications reduce the amount of the HIV virus in the body, preventing development of full-blown AIDS and extending life expectancy.

I would never advise a person with HIV/AIDS against using the "cocktail." The major disadvantage of this treatment is the number of pills involved, but this inconvenience is a small price to pay for a treatment that protects against a deadly disease. Unfortunately, the expense of the treatment means that millions of people in third-world countries where HIV/AIDS is rampant don't have access to these life-saving drugs.

We urgently need programs to make the cocktail more widely available and affordable. Beyond that, we need an effective vaccine to stem the still-escalating AIDS epidemic. Some 40 million people worldwide are living with HIV/AIDS, nearly one million of them in the United States. More than 40,000 people become infected with HIV in this country every year, and the spread of the disease continues unabated elsewhere. Reportedly, the disease is out of control in Russia with one out of every 100 adults infected. In India, 4.5 million people are infected - so many that World Health Organization authorities say that India may have overtaken South Africa as the most infected country.

Unfortunately, we don't yet have a vaccine, but that's not for lack of trying: a total of 30 vaccines are in human trials in 19 countries. The biggest obstacle investigators face is the ability of HIV to change its shape, frustrating efforts to find a vaccine that stops it from replicating.
To complement treatment with the HIV/AIDS cocktail of drugs, I recommend using a mixture of medicinal mushrooms with antiviral, immune-enhancing effects, as in the product called Host Defense from New Chapter.

If you're taking the HIV/AIDS cocktail, be cautious about the use of two herbal remedies. Studies at the National Institute of Allergy and Infectious Diseases found that taking garlic supplements twice a day for three weeks reduced blood levels of the anti-HIV drug saquinavir by approximately 50 percent. The same team found that St. John's wort can reduce concentrations in the blood of the protease inhibitor indinavir.

Andrew Weil, M.D.

How Dangerous is Avian Flu?

How Dangerous is Avian Flu? Provided by: DrWeil.com

Q: Is bird flu really as dangerous as we're being told? I'm skeptical. -- Aidan M.

A: There is cause for great concern. Avian flu is an infectious disease that affects birds, but it is caused by the same strain of the influenza virus responsible for most types of human flu. The strain now spreading in Asia, H5N1, is very dangerous - it kills nearly 100 percent of the birds infected and has been very damaging to poultry farms.

It also can infect humans, causing severe disease and even death. To become infected, you probably would have to eat raw, infected poultry or have had prolonged exposure to the virus. So far, at least 60 people in Asia have died after contracting H5N1. Most of these cases resulted from contact with infected poultry or contaminated surfaces, although health officials believe that, in some instances, the flu spread from person-to-person contact.

A chilling account of the worldwide pandemic that could occur should the virus that causes avian flu mutate in a way that would allow it to become an airborne infection that can affect humans was published in the Feb. 28, 2005 issue of The New Yorker.

Author Michael Specter wrote that while it is rare for a virus to mutate so that it is capable of infecting other species, the fact that H5N1 has already spread among a growing number of species besides poultry makes it more of a threat than other viruses that have emerged in the past few decades.

We are overdue for a global flu pandemic, and the one potentially brewing in Asia could be up there with the flu of 1918 that killed at least 50 million people. (See "The Great Influenza: The Epic Story of the Deadliest Plague in History," by John M. Barry for a gripping account.)

Monitoring the spread of the virus and studying its genetic structure may enable scientists to develop a vaccine to protect against it. Efforts to produce and test a vaccine in the United States that will be capable of protecting humans against H5N1 virus began in April 2005. With luck, we won't need it.

In the meantime, flu season is fast approaching; you can help protect yourself by taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. Be sure to wash your hands often and keep them away from your eyes and nose, and try to avoid contact with people who have respiratory illnesses.

If you're in Asia or planning to travel to countries with known outbreaks of avian flu, be sure to avoid poultry farms, contact with animals in live food markets, and any surfaces that appear to be contaminated with feces from poultry or other animals. And don't eat any local foods made with the blood of fowl, such as duck blood pudding.

At present, we have no vaccine capable of protecting against the avian flu although urgent efforts are underway to develop one. That doesn't mean that the currently available vaccine isn't worthwhile against other strains of the flu virus, which may be all we have to worry about this year.
I recommend flu shots for those over 65, as well as anyone with a weakened immune or respiratory system, nursing home residents, and health care workers who have regular contact with patients.
Pregnant women whose last two trimesters fall during flu season (generally November to April) might consider getting the shot.
Andrew Weil, MD

Why is More Tamiflu Being Produced For a Nonexistent Pandemic?

Despite its reputation as a worthless drug in the "battle" against the avian flu, you'll be seeing more of Tamiflu. Mega-drugmaker Roche Pharmaceuticals will expand production of its flu drug by a third over the course of 2006.
I suspect this excess production is connected to Roche's agreement with 65 countries to stockpile Tamiflu should a flu pandemic ever occur. For that matter, the supply of Tamiflu shouldn't exceed the debatable demand either. Roche has agreements with 15 other companies to produce the components necessary to make Tamiflu and has sublicensed its patent to companies in India and China to make generic versions of the useless drug.
Amazing how that pandemic the so-called experts and media pundits predicted this past winter just never came to pass...
Just another reminder, you don't need any drug or vaccine to protect you from the flu, if you follow my safe and proven flu protocol.
USA Today March 16, 2006

Pertussis vaccine proves effective in adults, adolescents

A vaccine to protect adults and adolescents against illness due to Bordetella pertussis infection--or whooping cough--has proved more than 90 percent effective in a national, large-scale clinical study, according to research results published in this week's issue of The New England Journal of Medicine.

The vaccine, researchers say, could be used to stem the increase in pertussis cases among adults and adolescents in the United States and thereby prevent the prolonged cough illness, which can result in hospitalization, pneumonia and cracked ribs in those populations. An important additional benefit of the vaccine may be to decrease transmission of the B. pertussis bacterium to infants, who are particularly vulnerable to severe illness, complications and death resulting from whooping cough. The illness annually affects 50 million people worldwide.

"During the 1990s, the number of reported pertussis cases among adolescents and adults more than doubled in the United States as the protective effects of earlier childhood immunizations have waned," says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, which funded the study. "This new study shows that an effective adult acellular pertussis vaccine is feasible and if routinely used could provide the U.S. population greater protection against the disease."

Known as the Adult Pertussis Trial, the 2.5-year study involved 2,781 healthy individuals between 15 and 65 years of age. Volunteers were randomly assigned to one of two similarly sized groups that received either the acellular pertussis vaccine or the control hepatitis A vaccine (Havrix). For purposes of the trial, pertussis cases were defined as illnesses with a cough lasting at least five days that occurred more than 28 days after vaccination and were confirmed through blood and nasal mucus testing.

Joel I. Ward, M.D., of the Center for Vaccine Research at the University of California, Los Angeles, led the multicenter clinical study. GlaxoSmithKline, based in Philadelphia, supplied both the pertussis test vaccine and the hepatitis A vaccine.

Ten confirmed cases of pertussis occurred during the trial--nine cases were among the individuals who received the hepatitis A vaccine. The researchers concluded that a single dose of the test vaccine was safe and 92 percent effective in protecting adolescents and adults against pertussis.

Although infants are routinely inoculated against pertussis through a series of three diphtheria-tetanus-acellular pertussis (DTaP) vaccines given in the first year of life, immunity has been shown to weaken after six to 10 years.

"The purpose of an adult pertussis vaccine is to prevent the disease in adults with the added benefit that it may help to put up a roadblock in the transmission of the disease, so that parents, grandparents and other adults are not unknowingly passing the disease along," says David Klein, Ph.D., of NIAID's Respiratory Diseases Branch.

In 2004, the highest number of U.S. pertussis cases was among individuals 10 to 18 years of age with roughly 6,500 cases reported, according to data from the Centers for Disease Control and Prevention. Infants less than six months old experienced the second highest number of pertussis cases last year, with an estimated 2,200 cases reported.

###
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.

Reference: JI Ward et al. Efficacy of an acellular pertussis vaccine among adolescents and adults. The New England Journal of Medicine 353(15):1555-1563 (2005).