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H1N1 Vaccine Shortage Prompts Backtrack:
One Vaccine is Suddenly Protective Now

After all the hype by infectious disease experts who claimed that multiple doses of the H1N1 vaccine would be necessary for flu protection, a sudden backtrack in their nefarious science now concludes that one dose will be sufficient and effective. What they don't tell you about, is why a shortage of vaccines precipitated this change and how conflicts of interest are running unchecked promoting the new one-shot protection fairy tale on behalf of big pharma.

Two-Dose Theory of Protection

Earlier in the spring, the World Health Organization (WHO) stated the public would need two doses to build resistance and get full immunity against the H1N1 virus. "It was an assumption based on pure speculation," says Dave Mihalovic, a vaccine researcher and Naturopathic Doctor. "Since there were no human clinical trials of H1N1 vaccines and subsequently no scientific evidence at the time the WHO made these statements, there was equally no credibility to ever substantiate the two-shot flu protection theory," said Mihalovic.

Health and Human Services' (HHS) Dr. Robin Robinson had said “We are moving forward with making a vaccine,” and if the government proceeds with a national program, enough supply will be produced to provide two doses for all Americans. Spokespersons like Anthony Fauci, from National Institute of Allergy and Infectious Diseases (NIAID), claimed adverse reactions aren’t to be expected and adding a second shot for Swine Flu “should not present a problem.”

Some trials were initiated by mid-2009 to assess the immune response of the H1N1 vaccine at two dose levels in adults. NIAID is sponsoring two major ongoing studies. The first was received by the U.S. National Institutes of Health on July 21, 2009 for a Sanofi Pasteur experimental H1N1 vaccine and the other was received on August, 20, 2009 for a CSL experimental vaccine.

Both trials are to assess safety concerns such as the occurrence of vaccine-associated serious adverse events. No results on the outcome of either of these trials are currently available. However, regardless of their conclusions, one must wonder if mass populations will receive the exact same vaccine formulation as those in the experimental versions.

Novartis, a bio-pharmaceutical company that manufactures the vaccine, has recommended that children participating in trials receive two shots. A pilot trial of Novartis adjuvanted cell culture-based A(H1N1) vaccine indicates that the "swine flu" vaccine elicited a strong immune response and was well tolerated. The trial was run by the UK's University of Leicester and University Hospitals of Leicester.

"Administering one, two, five or ten doses of influenza vaccine is redundant... any quantity or frequency of administered vaccines provides absolutely no short or long-term benefits to human health and offers no more protection than those individuals who are unvaccinated. Unbiased scientists who are independent of big pharma have well-established this fact. It is a criminal practice to continue the facade of promoting vaccines as protecting health when all they do is destroy it..." stated Mihalovic.

A report in mid-July from JPMorgan estimated that governments worldwide had ordered nearly 600 million doses of pandemic vaccine and adjuvant – a chemical that supposedly boosts its efficacy – worth $4.3bn (€3bn, £2.6bn) in sales, and there was potential for 342m more doses worth $2.6bn.

Shortages

On July 14th, 2009 there were reports that vaccine manufacturers had hit a snag in swine flu vaccine production. The viruses from which vaccines are produced are grown in eggs, and the WHO said pharmaceutical companies doing the work were reporting yields of half or less of what they expected.

Health minister Yoichi Masuzoe unveiled a plan in July 2009 to import vaccine for some 15 million to 20 million people to help cover shortages because production in Japan was forecasted to fall far short of the needed amount for up to 53 million people.

Last month, a spokesperson for the WHO said that Asia will not have enough H1N1 vaccines for swine flu when cold weather hits, Reuters reports.

"Nowhere is ready ... there is going to be massive underproduction of vaccines as compared to the needs and demand," said Manila-based WHO spokesman Peter Cordingley.

The US health department reports that 120 million doses of swine flu vaccine will be required to protect the population. Only one third of that number will be available in October when flu season begins. Only 45 million doses are expected, although that's expected to rise to 85 million doses by the end of October.

Dr. Robin Robinson, of the HHS was quoted in Reuters on August 18, 2009 stating: “We're trying to bring on more manufacturing...hopefully there are ways to bring that number up.”

Vaccine production around the world has been reduced dramatically from original projections. Mihalovic added that "it is virtually impossible for these manufacturers to produce and deliver these vaccines in the timeline they have proposed." It typically takes several years from the point of initial vaccine development to human clinical trials, a process which the manufacturers claim is being done in months.

"There is no possible way they can assess the safety and serious adverse events associated with these vaccines in such a short time period," stated Mihalovic.

Promoting the "One Shot is Effective" Fairy Tale

If production cannot meet capacity, why not change the rules? Backtracking on original recommendations and defying the expectations of experts, big pharma has now managed to show that the new H1N1 swine flu vaccine protects with only one dose instead of two, so the vaccine supplies now being made will go twice as far as had been predicted.

While the success of single dosing has effectively halved the potential global H1N1 vaccine market, the fact is there was never going to be anywhere near enough vaccine to go around and vaccine producers knew it, even in the early stages of the so-called pandemic. One-shot programs are cheaper, quicker and increase the bottom line.

“This is definitely a big deal,” said Dr. John J. Treanor, a vaccine expert at the University of Rochester. “People had been planning for a scenario that would require two doses.”

One editorial accompanying the research out of the University of Leicester said: "The obvious advantage of a one-dose schedule is that in the current time of vaccine scarcity it doubles the number of people who may be vaccinated with a fixed amount of vaccine."

Australian shot maker CSL Ltd. published results of a study in the New England Journal of Medicine that found between 75 percent and 96 percent of vaccinated people should be protected with one dose — just remarkable considering scientists thought for at least 8 months that it would take at least two doses. CSL lists Guillain-Barre Syndrome (GBS) as vaccine side effect of their vaccine.

Novartis said a pilot trial of their Celtura H1N1 vaccine run by Britain's Leicester University with 100 volunteers showed a potentially protective immune response in 80 percent of patients after one dose and more than 90 percent after two doses.

It was Dr Iain Stephenson who led the trial at the Leicester Royal Infirmary. He stated that "the clinical trial of Novartis MF59-adjuvanted cell-based A (H1N1) vaccine indicates that the "swine flu" vaccine elicits a strong immune response and is well-tolerated." Coincidently, it is also Dr. Stephenson who has received funding from manufacturers of influenza vaccines, including Novartis and GlaxoSmithKline (GSK) for scientific research. He also received consultancy or speakers fees and support for travel to scientific meetings from Novartis, GSK and Baxter Vaccines. Conflict of interest statements are littered throughout most of the studies Dr. Stephenson is involved in.

In September 2008, Dr. Stephenson was paid by Novartis to highlight that the MF59 adjuvanted vaccine induces protective antibody levels against diverse strains of avian flu. He stated that the results of that study provided a "rationale to prevent pandemic influenza by proactively immunizing the public with stockpiled pre-pandemic vaccines containing MF59."

MF59 is an unapproved ingredient in experimental anthrax vaccines and has since been linked to the devastating autoimmune diseases suffered by countless Gulf War vets according to data published in the February 2000 and August 2002 issues of Experimental and Molecular Pathology. In most countries worldwide, MF59 is not approved or licensed for use in any vaccine, including the United States.

The MF59 adjuvant now readily used in H1N1 vaccines was given positive and conclusive results last winter through at least one study with direct conflicts of interest. Almost every single person involved in the study, including Grazia Galli, Monia Bardelli, Carmine Malzone, Flora Castellino, Giuseppe Del Giudice, Michaela Praus, Angelika Banzhoff and Volker Brauer are all employees of Novartis and have received support from vaccine producers including scientific research, speaker's fees, and attendance at scientific meetings.

Other affiliates in the study, Kathy Hancock, Katja Hoschler, Emanuele Montomoli and the UK Health Protection Agency have also received funding from Novartis.

"The bias involved in most vaccine studies is overwhelming. Think of a serial killer investigating himself for murder and you might get a rough idea of how vaccine studies are conducted" Milhalovic concluded.


Reference Sources
September 15, 2009

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