Thursday, September 3, 2009

WHO Admits to Releasing Pandemic Virus into Population via 'Mock-Up' Vaccines

The document on the WHO website linked below states that it is common procedure to release pandemic viruses into the population in order to get a jump ahead of the real pandemic, so as to fast track the vaccine for when it is needed.

In Europe, some manufacturers have conducted advance studies using a so-called "mock-up" vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. According to the website, “Such advance studies can greatly expedite regulatory approval.”

WORLD HEALTH ORGANIZATION

Safety of pandemic vaccines
Pandemic (H1N1) 2009 briefing note 6


6 AUGUST 2009 | GENEVA -- WHO is aware of some media reports that have expressed concern about the safety of vaccines for pandemic influenza. The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls.

Vaccines are among the most important medical interventions for reducing illness and deaths during a pandemic. However, to have the greatest impact, pandemic vaccines need to be available quickly and in large quantities.


Pandemic influenza vaccine manufacturing process and timeline
6 August 2009

During the 1957 and 1968 pandemics, vaccines arrived too late to be used as an effective mitigation tool during the more severe phases of the pandemics. Influenza vaccines had not yet been developed when the 1918 pandemic swept around the world, eventually killing an estimated 50 million people.

In 2007, as part of preparedness for an influenza pandemic, WHO worked together with health officials, regulatory authorities, and vaccine manufacturers to explore a broad range of issues surrounding the regulatory approval of pandemic vaccines.

Ways were sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines. Different regulatory pathways were assessed, and precautions needed to ensure quality, safety, and effectiveness were set out in detail.

Fast-track procedures for approval

Regulatory authorities have shown great flexibility in developing procedures for fast-tracking the approval and licensing of pandemic vaccines.

In some cases, pandemic vaccines are not regarded by regulatory authorities as entirely “new” vaccines, as they build on the technology used to produce vaccines for seasonal influenza, established procedures for testing and regulatory control, and an extensive body of safety data.

In such cases, approval procedures are similar to those applied to “strain changes” made each year when seasonal vaccines are modified to match circulating viruses in the Northern and Southern Hemispheres.

Specific regulatory procedures have been devised to expedite the approval of pandemic vaccines. In the USA, for example, fewer data are required when the manufacturer already has a licensed influenza vaccine and intends to use the same manufacturing process for its pandemic vaccine.

In the European Union, the European Medicines Agency uses a rolling review procedure whereby manufacturers can submit sets of data for regulatory review as they become available, without having to wait until all data can be submitted together in a single formal application.

Also in Europe, some manufacturers have conducted advance studies using a so-called “mock-up” vaccine. Mock-up vaccines contain an active ingredient for an influenza virus that has not circulated recently in human populations and thus mimics the novelty of a pandemic virus. Such advance studies can greatly expedite regulatory approval.

Special safety concerns

Influenza vaccines have been used for more than 60 years and have an established record of safety in all age groups. While some serious adverse events have been reported, these have been rare.

Nonetheless, special safety issues will inevitably arise during a pandemic when vaccine is administered on a massive scale. For example, adverse events too rare to show up even in a large clinical trial may become apparent when very large numbers of people receive a pandemic vaccine.

Some adverse events will be coincidental – that is, associated in time with vaccine administration, yet not directly caused by the vaccine. Genuine adverse events directly caused by the vaccine may also occur, but cannot be predicted in advance. Given the safety record of seasonal vaccines, such events are expected to be rare.

Time constraints mean that clinical data at the time when pandemic vaccines are first administered will inevitably be limited. Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.

For these reasons, WHO advises all countries administering pandemic vaccines to conduct intensive monitoring for safety and efficacy, and many countries have plans in place for doing so. On the positive side, mass vaccination campaigns can generate significant safety data within a few weeks.

International sharing of data from such post-marketing surveillance will be vital in guiding risk-benefit assessments and determining whether changes in vaccination policies are needed. WHO has developed standardized protocols for data collection and reporting in real-time, and will communicate findings to the international community via its web site.

Dr Mercola's Comments:

On June 11 the World Health Organization (WHO) raised its swine flu pandemic alert from a 5 to a 6. Phase 6 is the highest level alert, and reflects the speed with which a virus is spreading -- not its severity.

This classification also allows for a vaccine to qualify for a “fast-track” procedure for licensing and approval, and this process is now ongoing for the swine flu vaccine.

What you may not know, however, is that WHO, together with health officials, regulatory authorities and vaccine manufacturers, have been working since 2007 – long before this new “threat” of swine flu emerged – to “explore a broad range of issues surrounding the regulatory approval of pandemic vaccines.”

According to the WHO website:

“Ways were sought to shorten the time between the emergence of a pandemic virus and the availability of safe and effective vaccines.”

One such method used in Europe is to conduct advance studies using a “mock-up” vaccine that contains an active ingredient for an influenza virus that has not circulated recently in human populations.

When testing these mock-up vaccines, it is very possible to release the novel influenza virus into the population, as its purpose is to “mimic the novelty of a pandemic virus” and “greatly expedite regulatory approval.”

Government officials have other tricks up their sleeves to ensure these new, barely tested vaccines easily make it to market as well, such as:

Labeling the vaccine a “strain change” rather than an entirely “new” vaccine. This method states the new vaccine has built on technology used to produce vaccines for seasonal influenza, and the change for the pandemic vaccine is similar to a strain change used to produce a new seasonal vaccine each flu season.

In the United States, vaccine manufacturers are required to submit fewer data if they already have a licensed flu vaccine and will use the same manufacturing process for the pandemic vaccine.

Using a “rolling review procedure.” This allows manufacturers to submit sets of data for regulatory review “as they become available.” In other words, they’re free to distribute the vaccine and then submit the safety data later on.

Would You Want a Fast-Tracked Vaccine Injected Into Your Body?

By very definition, fast-tracked vaccines are those that have received very little safety testing prior to being used. So any time you agree to get one, you are essentially a guinea pig.

Vaccine manufacturer GlaxoSmithKline has actually stated:

"Clinical trials will be limited, due to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available."

And WHO likewise says:

“Time constraints mean that clinical data at the time when pandemic vaccines are first administered will inevitably be limited. Further testing of safety and effectiveness will need to take place after administration of the vaccine has begun.”

Why would anyone who knows the facts sign up for a vaccine that really needs further safety studies … but won’t receive them until AFTER it’s already been given out? By then it will be too late.

So please realize that if you or your child receive a swine flu vaccine, you will be acting as a TEST subject.

Remember this vaccine will not be made using the methods of the past. In order to speed up the cultivation of the virus and the manufacturing process, they’re using human liver cells instead of chicken eggs. Whether this new procedure is better or worse than the old method, I can’t say … but it’s never been used before and they have not had time to conduct any human testing.

So, it’s a giant game of Russian Roulette that you simply want to avoid.

Nearly all of the vaccines created will also include thimerosal (mercury), and the toxic adjuvant squalene, both of which have been clearly shown to carry significant health risks.

You should know, too, that vaccine makers and federal officials have been rendered immune from lawsuits. Should anything go wrong with this current vaccine they will not have to pay a single cent to anyone!

Who Stands to Benefit From the Swine Flu Pandemic (and Future Pandemics)?

This is the question you need to ask yourself when you hear the media dishing out the latest statistics about the swine flu pandemic.

In the last few days alone, I’ve seen major news outlets warning that come flu season, the swine flu could kill 90,000 Americans and hospitalize 2 million. This sounds a lot like the fear-mongering that went on during the Bird Flu pandemic (that never materialized) back in 2005.

Back then scientists and governments were congratulating themselves for averting a threat that never was by stockpiling worthless vaccines. Now I’m having déjà vu.

In response to this newest swine flu pandemic, what did the Centers for Disease Control and Prevention recently suggest?

Swine flu shots for all! Of course, what else would you expect?

As the Washington Post reported, CDC said: “As soon as a vaccine is available, try to get it for everyone in your family.”

Well, you might be tempted to do just that if you believe the sensational number of swine flu deaths they’re predicting. But, really, these numbers are not based on facts.

WHO continues to define the severity of the H1N1 virus to be moderate, generally defined as an illness requiring neither hospitalization nor even medical care. Most cases are having MILD symptoms that clear up on their own.

Further, no one really knows for sure just how many cases of swine flu there are, because some countries are no longer confirming them by lab.

In the UK, for example, they now appear to be collecting swine flu data online and via the phone, based on nothing but self-assessment.

So did they really contract the swine flu?

Or did the vast majority of them simply have a case of the sniffles or a seasonal flu bug? Without laboratory confirmation, no one will ever know, but they sure are using those numbers to scare you!

Going back to my original question though, you must ask yourself who stands to benefit from all of this paranoia and hysteria.

Of course you know the answer to this one.

Big Pharma … which stands to gain up to $49 billion a year on the swine flu vaccine alone plus an infinite amount on top of that for future pandemic vaccines.

The vaccine manufacturers would love for every man, woman, and child to heed the CDC’s advice to get vaccinated. But now you know better.

The swine flu is typically a mild illness.

The swine flu vaccine has not been tested for safety or efficacy, but we DO know it will contain harmful additives.

The choice, to me, is obvious. And in the future, anytime a new “pandemic” appears and officials urge you to rush out and get a shot, please remember this article and ask yourself if it’s really you who stands to benefit from their advice.

Want to Learn More AND Get Involved? Attend This World-Class Vaccine Conference!!

Interestingly the swine flu vaccines are going to be available in the US around the time the finest vaccine conference in the world will be held. If you want to learn the absolute latest and best strategies for swine flu then Washington DC is the place to be October 2-4. I will be sharing my strategies live at the event.

So join me at the National Vaccine Information Center (NVIC) Web site, and join us in taking action against the potential threat of mandatory swine flu vaccinations.

October 2-4, 2009, the International Vaccine Conference will be held in Reston, Virginia (Near Washington, D.C.). It is the best vaccine conference in the world, and is only held about once every five years.

It is relatively inexpensive to attend, and highly recommended. But you’ll need to hurry to reserve your seat, as there is only room for 1,000 and the seats are going quickly.

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