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Thu., Aug 06 2009 3:44pm (EDT)
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CDC Finds Swine Flu Tests Often Wrong
By Associated Press
Updated: 4 hours ago

 

A rapid test to diagnose swine flu is often wrong… that’s according to Atlanta based Centers for Disease Control and Prevention.

 
A CDC study finds that swine flue tests come up inaccurate half the time.

It’s the first government study of how well the rapid tests work.

Scientists looked at the product from three companies and found at least half of the time they’re inaccurate. And that they’re better at diagnosing seasonal flu.

In the event a test comes back negative… the CDC recommends doctors order a more precise lab test and in the meantime prescribe medicines like Tamiflu.
 

 

Legal immunity set for swine flu vaccine makers

http://news.yahoo.com/s/ap/20090718/ap_on_he_me/us_med_swine_flu

By MIKE STOBBE, AP Medical Writer Mike Stobbe, Ap Medical Writer
Fri Jul 17, 8:15 pm ET

ATLANTA � The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.

Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.

Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.

The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public health emergencies. It allows for a compensation fund, if needed.

The government takes such steps to encourage drug companies to make vaccines, and it's worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.

The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It's likely that more than 1 million Americans have been sickened by the flu, many with mild cases.

The virus hits younger people harder that seasonal flu, but so far hasn't been much more deadly than the strains seen every fall and winter. But health officials believe the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.

"We do expect there to be an increase in influenza this fall," with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases.

On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.

The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.

Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.

"The government paid out quite a bit of money," said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.

Vaccines aren't as profitable as other drugs for manufacturers, and without protection against lawsuits "they're saying, 'Do we need this?'" Sugarman said.

The move to protect makers of a swine flu didn't go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will likely call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.

"If you're going to ask people to do this for the common good, then let's make sure for the common good that these people will be taken care of if something goes wrong," Pennock said.

___

AP Medical Writer Lauran Neergaard contributed to this report from Washington.
 

Swine Flu Vaccine Fast-Tracked to September?
www.webmd.com/cold-and-flu/news/20090717/swine-flu-vaccine-fast-track

 

Panel: Skip Most Safety, Efficacy Tests to Get Swine Flu Vaccine in September
By Daniel J. DeNoon
WebMD Health News

July 17, 2009 -- Pandemic swine flu vaccine should be fast-tracked, with vaccinations starting in mid-September -- soon after schools open.

That recommendation came today in a unanimous vote by the National Biodefense Safety Board (NBSB), an influential board of outside advisors to Health and Human Services Secretary Kathleen Sebelius.

 

Getting swine flu vaccine by September means skipping all but the most preliminary clinical tests of vaccine safety and effectiveness. But it means getting some 60 million to 80 million doses nearly at the same time the CDC expects the next wave of the pandemic to hit the U.S.

"We cannot wait beyond mid-August [to make a decision] if vaccine is to be in supply by mid-September," the panel's pandemic influenza working group states in its recommendations. "A critical goal is to have some [standalone] novel H1N1 vaccine available by mid-September 2009, should it be needed."

Why rush through a swine flu vaccine? The first wave of the swine flu pandemic is only just starting to ebb in the U.S. But the virus spreads quickly among children -- and the nation's schools begin opening in late August. "A second wave is likely to occur, as soon as fall 2009," the recommendations state. "Best estimates suggest that infection rates will be two to three times higher than expected with seasonal influenza. The second wave could peak in October, but we must anticipate onset as early as September."

Initial doses likely will go to those most severely hit by the pandemic so far: infants, toddlers, school-age children, pregnant women, and adults with risk factors for severe flu disease. Next week, the CDC's vaccine advisory board will recommend a priority list for exactly who will first get the vaccine. The NBSB recommendation puts into words a fear that government officials have so far expressed only privately. "Having vaccine only after the peak [of the pandemic] may be worse than having no vaccine at all: It incurs all of the risk and cost with no potential benefit," the recommendation reads.

The National Biodefense Science Board advises Sebelius on emergency preparedness for biological threats. Whether to act on the NBSB's decision is up to her -- and, ultimately, to President Barack Obama.

Why deploy a vaccine that hasn't completed safety and efficacy testing? Because we already have a lot of experience with similar vaccines, concluded the NBSB flu vaccine working group, led by University of Utah flu expert Andrew Pavia, MD.

Pandemic swine flu is a type A, H1N1 flu virus. For decades, a type A H1N1 vaccine has been part of the regular seasonal flu vaccine, and the new vaccine is made exactly the same way.

Fast-tracking the vaccine will mean guessing at the best dose, but that's an educated guess based on the well-established dosage for the seasonal H1N1 vaccine.

A more critical guess is whether people will be protected against the new flu bug with only one shot of vaccine. The NBSB working group suggests that previous exposure to H1N1 virus and H1N1 vaccine will prime virtually the entire population so that only one dose is needed -- even though the seasonal vaccine does not protect against pandemic swine flu.

Fast-tracking the vaccine would also mean deciding who's first in line. Robin Robinson, PhD, director of BARDA, the Health and Human Services agency responsible for the logistics of emergency medical supplies, says 60-80 million doses could be available in mid-September -- if vaccine makers start packaging their products in mid-August. Similar quantities would follow in each subsequent month until demand was met.

Voting members of the NBSB include experts from universities, the pharmaceutical industry, and medical groups. NBSB chairwoman Patricia Quinlisk, MD, MPH -- who was absent from today's telephone-based meeting -- is director of the Iowa health department. Non-voting members of the NBSB include representatives of the White House, the Health and Human Services Department, national security agencies, the FDA, and NASA.

 

 

 
 

Novel Influenza A H1N1 (Swine Flu) Updates & Alerts

Consistent with national influenza surveillance programs, the Oklahoma State Department of Health will discontinue reporting individual case numbers of novel H1N1 influenza by county effective August 1, 2009.

(I wonder why? This and reports of swine flu being diagnosed over the phone leads me to believe this pandemic is made up.)

 

 As the new influenza virus has spread more broadly, the case numbers no longer reflect the true burden of disease and states are transitioning their surveillance efforts in preparation for the upcoming regular influenza season. Future surveillance information will provide more “snapshot” data on whether flu activity is increasing or decreasing, locations where more flu is being identified, and any indicators that the severity of illness is changing.

The Oklahoma State Department of Health (OSDH) and public health officials nationwide are tracking and investigating human cases of a new strain of influenza virus that originated in swine, but is now being spread person-to-person. Cases of this new H1N1 flu in Oklahomans can be determined by testing at the OSDH Public Health Laboratory. All positive test results are reported by county of residence with full case investigations limited to persons with more severe illness requiring hospitalization, pregnant women, or persons associated with facilities of special interest. These may include nursing homes, daycares, or healthcare facilities. Persons suspected or confirmed to have H1N1 influenza are advised not to go to work, school, or other public places until at least 24 hours after symptoms have resolved.

The purpose of the OSDH “swine flu” website is to report the number of laboratory-confirmed cases of the new strain of H1N1 flu in Oklahoma, provide fact sheets and other informational materials about the disease, and offer easy access to other links and resource documents of interest to specific audiences including healthcare professionals; faculty and staff at schools, colleges & universities; childcare workers; business leaders; and travelers.

Number of Reported Novel Influenza A H1N1 (Swine Influenza) Cases by County, Oklahoma* 
(as of July 29, 2009, 2:00 P.M. CST)

County New Cases Reported Total Confirmed
Cases Reported
Adair 1 1
Beckham 0 1
Caddo 0 1
Canadian 0 3
Carter 0 3
Cleveland 3 17
Comanche 1 3
Custer 2 3
Garfield 0 3
Garvin 0 1
Grady 0 1
Jackson 0 10
Kay ^ 0 12
Kingfisher 1 3
Le Flore 0 1
Logan 0 9
Marshall 0 2
McClain 0 2
Murray 1 1
Muskogee 0 2
Oklahoma 9 66
Payne 0 10
Pontotoc 0 4
Pottawatomie 0 4
Pushmataha 0 1
Rogers 1 3
Seminole 1 2
Sequoyah 0 2
Stephens 1 3
Texas 0 1
Tulsa 11 56
Wagoner 2 4
Woodward 0 1
Oklahoman Living
Out-of-State
0 1
Total 34 237

^ A novel H1N1 influenza-associated death has been reported from a person residing in this county.

* Posting of cases may be temporarily delayed pending patient and physician notifications.

Eventdate_ 07292009.jpg

Today OSDH reports thirty-four new confirmed cases of swine origin H1N1 influenza bringing the total number of confirmed cases statewide to 237. New case(s) were identified in Adair, Cleveland, Comanche, Custer, Kingfisher, Murray, Oklahoma, Rogers, Seminole, Stephens, Tulsa and Wagoner counties. This was the first time that cases were reported from Adair and Murray counties.

Current Case Summary: Of the 237 confirmed H1N1 cases reported to date, 50.7% (120/237) are female; 57.8% (137/237) are children < 18 years old. The age range of all cases is 11 months - 71 years. Seven (2.9%) of the case patients who had underlying medical conditions were known to be hospitalized. Most affected persons have experienced symptoms of fever, cough, sore throat, and body aches consistent with other flu viruses and fully recovered at home. Onset of H1N1 influenza illness among all cases has ranged from April 23 through July 21. Of the 237 confirmed cases, there has been one death reported in an adult male who had underlying medical conditions and was not hospitalized (0.42%).

Cumulative Case Count of Swine Origin Influenza A H1N1 by Date, Oklahoma, 2009 (63k.pdf) - Click on this link to view a graph that displays the cumulative number of influenza A H1N1 cases at each date.

Current OSDH updates:
First Oklahoma Novel H1N1 Influenza A (Swine Flu) Death Reported

 


July 29, 2009
Figuring How To Terrify Us Over Swine Flu
By MICHAEL FUMENTO Investor's Business Daily

'U.S. health officials say swine flu could strike up to 40% of Americans over the next two years and as many as several hundred thousand could die."

So declares an Associated Press article, the writer of which you can picture trying to catch his breath as he pounds away at the keyboard. In its exclusive revelation of unpublished figures, AP says: "Those estimates from the Centers for Disease Control and Prevention (CDC) mean about twice the number of people who usually get sick in a normal flu season would be struck by swine flu."

No, they don't. The CDC's influenza Web site shows they're essentially the same. Welcome to the wonderful world of swine flu hysteria, in which health agencies be it the World Health Organization (which declared a worldwide pandemic with just 244 deaths) or the CDC can tell any scary story they want with the assurance that the mainstream media will never challenge them. That includes pointing to a piglet and proclaiming it to be a wild, raging boar.

It seems that to ask a journalist at the nation's largest wire service to merely spend a few minutes on a single Web site or even to simply ponder what he's just typed is to ask too much. Thus, the CDC's influenza Web site states that "on average 5% to 20% of the population" will contract flu each year which, save for the hapless souls who contract it two seasons in a row, would be the same as "up to 40% of Americans over the next two years."

Yet AP's writer, still on that adrenaline rush, declares that while "in a normal flu season, about 36,000 people die," "because so many more people are expected to catch the new flu, the number of deaths over two years could range from 90,000 to several hundred thousand, the CDC calculated."

Really? Let's do our own calculations.

Of the U.S. population, 5% to 20% comes out to 15 million to 60 million people. The CDC actually provides those figures, thereby sparing the arithmetically challenged. Swine flu has infected "more than 1 million Americans, the CDC believes," AP informs us, with "302 deaths." Now just keep that calculator holstered for a minute, pilgrim! Do 302 swine flu deaths out of "more than 1 million infections," given what we now know about seasonal flu deaths, seem alarming? Okay, now grab the calculator and divide those "more than 1 million infections" into the 302 deaths. The fatality rate is less than 0.03%.

How much less? The CDC first used the "one million" figure over a month ago. Either there have been a lot of new infections in that time, meaning the death rate has indeed fallen well below 0.03%, or else there have not been which is also good news.

But let's be sporting and use an even million.

Dividing "15 million to 60 million infections" into 36,000 deaths provides a seasonal flu death rate ranging from 0.006% to 0.024%. That's twice to eight times the swine flu death rate. Are you still getting out the plastic sheeting and duct tape? Ah, but AP has another explanation for the potentially high toll. It's if "a new vaccine and other efforts fail."

Far more likely than an outright failure would be what's called a "mismatch." That means the vaccine gives only partial coverage. Still, some of those vaccinated would not become infected and therefore neither die nor infect others, who in turn would neither die nor infect others. So even a mismatch could considerably lower deaths.

Moreover, lest we forget in our haste to produce front-page material,there's no swine flu vaccine now. Will a "failed" vaccine somehow make swine flu more lethal?

Conclusion: The CDC is playing the same games it did with heterosexual AIDS, SARS and avian flu promoting panic far out of proportion to the problem. I wrote exposes on each of those scares at the time. The "secret"? Checking sources, putting facts before fear-mongering and keeping a sense of perspective right next to the calculator.

Why the CDC promotes such hysteria is another story. But safe to say hat among the reasons are that it knows the media have little interest in the fairy tale called "The Boy Who Cried Wolf." For the American public, that's very unhealthy indeed.

Fumento, a former IBD reporter, is director of the Independent Journalism Project, where he specializes in health and sciences issues.
[iCopyright]

 

Take a look at this video and play close attention to Dr Faucio when he mentions adjuvants.

http://www.youtube.com/watch?v=svHSXeZqics

 

On June 30, 2009, "Dr. Nancy" of MSNBC interviewed Anthony Fauci, MD, of the NIH and attorney Diane Miller who is advocating against mandatory vaccination. Miller brought up the new “oil-in-water” adjuvant to be used in the H1N1 vaccine being produced for this fall and questioned its safety.  Dr. Fauci rebutted Miller’s concern about this adjuvant by claiming it would not be used in children or the vaccine trial. Fauci also claimed they wouldn’t be using any “adjuvanted vaccines” for this trial. 

All vaccines produced for humans are adjuvanted. The trials he is mentioning are not long term but only three to five weeks which is not long enough to evaluate safety and efficacy of an experimental adjuvant that has caused 100% paralysis in addition to autoimmune disorders of lab animals.  His assurance that adjuvanted vaccines will not be used appear false as contracts to purchase the oil-based adjuvant have already been executed.

 (See chart below)

HHS Contracting Activities

Since 2004, HHS has contracted with manufacturers that currently hold U.S. licenses for flu vaccine as part of the National Strategy for Pandemic Influenza. In May 2009, HHS issued new orders on these contracts to produce a bulk supply of vaccine antigen and adjuvant and to produce pilot (also called investigational) lots of a 2009 H1N1 vaccine. Most will be stored in bulk, and a small amount will be prepared as vaccine for use in clinical studies to evaluate vaccine safety and the dosage required for a protective effect. This research will include studies with adjuvant to determine its safety and the effect it would have on the immune system’s response.

  

Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: May 22, 2009

Manufacturer

Bulk Vaccine Antigen

Oil-In-Water Bulk Adjuvant

Novartis $150 million $139 million
GlaxoSmithKline $ 38 million $144 million
Sanofi Pasteur $191 million  
CSL Biotherapies $180 million  
MedImmune $ 90 million  
Total $649 million $283 million

 

Orders for Bulk Supply of H1N1 Influenza Vaccine Antigen and Adjuvant: July 9, 2009

Manufacturer

Bulk Vaccine Antigen

Bulk Virus Concentrate/FFF

Oil-In-Water Bulk Adjuvant

Sanofi Pasteur $61,425,000 0 0
GSK $0 0 $71,400,000
Novartis $346,334,450 0 $343,810,470
CSL $0 0 0
MedImmune $0 $61,008,000 0
Total $407,759,450 $61,008,000 $415,210,470

 

  The tables above from https:www.medicalinterventions.com are current as of August 2, 2009.

We must assume Fauci knows about these purchases.  When prompted to explain away Miller’s concerns about the oil-in-water adjuvant, maybe Fauci was forced to admit that the adjuvant won’t be used in the trials and only added to the H1N1 vaccine after the vaccine has been deemed “safe.”

 The new “adjuvanted” vaccine

The millions, possibly billions of vaccine doses being prepared for the “unstoppable” swine flu is different from the normal flu shot in a couple of ways. As previously stated, all human vaccines administered to prevent diseases contain adjuvants. An adjuvant is the ingredient that stimulates the body into recognizing the virus and mounting an immune response. Most vaccines contain alum or aluminum hydroxide to perform this function. What’s novel and especially disturbing in this vaccine is the new adjuvant that will be used. You hear it softly mentioned in articles as an oil-water emulsion that stimulates the immune system to react strongly. Or it’s mentioned as a lipid-based adjuvant that has been used for years in Italy and Spain, giving it an air of safety and efficacy. Nothing could be farther from the truth. This vaccine adjuvant is dangerous. In an attempt to make it safer it has had many incarnations. MPL, MF-59, squalene etc. All had the same outcome-autoimmune diseases. Take a look here at the study done in Gainesville Fl.

http://www.bloomberg.com/apps/news?pid=20601202&sid=alZncUEvwtIM 

A safety concern was raised in 2004 when researchers at the University of Florida in Gainesville reported that mice injected with oils used in the adjuvants developed conditions of the type that occur when the body’s immune system produces an excessive protective reaction.

 In other words, autoimmune. This is not an adjuvant to trust.

 

Sample letter....

 

Dear Gov., State and Fed. legislator

Many (insert state) families are alarmed that the government may attempt to force them to submit to a vaccine or treatment they do not want because of recent discussions at the state, federal, and even international level about an impending aggressive fall mass vaccination campaign for H1N1, or swine flu.

Families are alarmed and confused because they have been told by the World Health Organization (WHO) that we are at a deadly world Pandemic 6 level. But on the other hand the WHO has recently warned us about the dangers of an untested vaccine and tells us that symptoms have been mild and that relatively few people have been affected. In looking into this further I have learned that, the WHO has now stopped keeping track of the number of people diagnosed with H1N1. Further, the Federal government has appropriated $ 7 billion dollars to pay for these vaccines and since they are experimental and uninsurable, the manufacturers have been absolved of any liability.

Foremost in the minds of many (your state example :Floridians) are questions about how they will be able to protect themselves and their families from vaccines and treatments that have debatable safety, efficacy, and even necessity, and how they will protect their right to make their own health care choices.

Recent hype and hysteria in the media and private sector, and the distortion of the science by governmental and international bodies, coupled with the pharmaceutical industry's rush to force more profits from vaccines which are untested, experimental, uninsurable and dangerous, and from drugs which are known to be both ineffective and unsafe, now cause me to write to you to express my concerns and ask for your help.

It is my understanding, that pursuant to (insert state) state law, Floridians have the right to decline vaccines of any kind based on medical history or religious beliefs. If there is an international, federal or state (or any combination thereof) declaration of health emergency or pandemic, will our current state laws still apply and protect my right to refuse vaccination?

In addition, according to Federal Law (NVICP 1986) I understand that I am entitled to informed consent in any vaccination process. To be able to make an informed choice in regard to the novel influenza A (H1N1) virus vaccine, I need to know what are ALL the ingredients of the proposed flu shots.

Specifically:
1) What is the nature of the virus antigen(s), ( live, live attenuated, inactivated, bio-engineered, etc.)?
2) What adjuvants are present (squalene, aluminum, etc.)?
3) Are there human or animal cells present?
4) Does it contain thimerosal / mercury?
5) What are ALL the other ingredients (formaldehyde, anti-biotics etc.)?


If I decline a vaccination or drug, will there be penalties?

Will I be able to shelf-shield in my own home to protect my family from exposure to toxins? If I am exposed to a toxin, will I be able to self-quarantine in my home? If I become sick, will I be able to stay in my own home or preferred-location to recover?

Will I be forced at any time to go to a location directed by the government?

Will I be incarcerated?

Will I be charged with a crime or be fined?

It would seem that, if required for public safety, sanction-free personal exemptions from
mandatory drug or vaccination treatment would be a far better solution. I have learned that this type of exemption is available in Minnesota. People who choose not to receive vaccination or drugs should have the opportunity for self-quarantine, self-shielding, and preferred-location isolation with appropriate support including food, water, communication and provision of medications or supplies of their choice. This alternative would honor and protect individual freedoms and choice in health care and would be far less expensive and socially disruptive than the forced treatment and relocation of people.

Due to the urgency of this situation, I look forward to your earliest response.

Thank you.

Sincerely,


Xxxx xxxx

Swine flu vaccines not proven effective? FDA wants you to get them anyway!

http://www.wrightnewsletter.com/etips/ht200908/ht20090803a.html
They don't know if they're safe OR effective, but that probably won't stop the FDA from approving H1N1 vaccines.

Trial data has yet to prove the safety and effectiveness of H1N1 (swine flu) vaccines. In fact, only one of the five companies seeking approval has even STARTED human trials.

But—surprise, surprise—that's probably not going to stop the FDA from approving them.

Data will start coming in next month, and will continue through the early part of next year. But the World Health Organization wants to start vaccinating people in October, so they don't have time for pesky details like whether or not the vaccines are safe.

In fact, the whole thing will take on a scary trial-and- error approach. FDA officials say they'll update the immunization program as the trials shed more light— including whether or not two doses are better than one, or if a vaccine turns out to be ineffective.

In that case, emergency authorization for an oil-in-water adjuvant may be needed. The adjuvant sparks a stronger immune reaction, but causes more side effects.

What's perhaps most alarming is that, according to FDA officials, approving a vaccine without safety data is actually not uncommon (though this situation is new and exciting in that they don't usually approve them when major clinical trials of safety are ongoing)!

Seasonal flu vaccines are actually approved using the FDA's "strain change" process, in which manufacturers actually don't even have to provide information on whether the vaccines are safe—or if they even work!

That's right—put it out there, see if it works and how many people are hurt in the process, and clean up the aftermath later.

Look. Swine flu could end up being a very real problem in the coming months. But we can't let our panic get the best of us—shooting people up with unproven (and possibly unsafe) drugs could have disastrous consequences.

You know, I don't know what it's like to be a guinea pig. And I have absolutely no interest in finding out.

Source:
"FDA Likely to Approve H1N1 Vaccine In Advance of Data," Medpage Today (www.medpagetoday.com).

PUBLIC HEALTH

CDC Documents Forecast Fight Over Vaccines

By Jane Akre injuryboard.com bit.ly/185lao

Internal Centers for Disease Control and Prevention (CDC) media talking points offer a peak behind the curtain of the struggle ahead in convincing the public about the need for vaccines to fight swine flu.

The three-page draft called, “Vaccine Safety Communication/Media Strategy” was created as a guide to “effective health communication” to be used by CDC staff and public health employees as they address concerns by parents worried about the vaccine-autism link.But they may well forecast the attitude of the federal agency as it prepares to launch an aggressive public relations campaign this fall encouraging Americans to be vaccinated against swine flu, H1N1.

Like vaccines used on children, and some flu shots used today, thimerosal, the mercury-based preservative, may be present in some versions of the swine flu vaccine and additives such as aluminum, suspected in the link to the debilitating cognitive/ social disorder. The draft was made available on the Web site, Age of Autism bit.ly/PEKed by attorney James Moody, a consultant to the federal vaccine court and on the board of both the parent group, SafeMinds, and the National Autism Association.

Critics The draft variously characterizes parents and nonprofit advocacy groups concerned about vaccine safety as “anti-vaccine,” “detractors," “fringe groups," “Hostile parents and non-professionals,” and “anti-government activists,” who envision vaccines as more harmful to individual children than good or believe in conspiracy theories related to vaccination programs."Then in an apparent contradiction that supports the above parents, the draft concedes, “Last year in the United States, the number of reported adverse events associated with vaccination was greater than the number of reported cases of vaccine-preventable disease"
Although it doesn’t give numbers, childhood diseases such as measles, mumps, and rubella have been decreasing, while vaccine-associated autism reports, in as many as one in 150 children, are called "the fastest-growing developmental disability in the United States."

Also, in an apparent direct contradiction to the standard assurances of vaccine safety frequently offered by federal officials, the draft admits "Some claims against vaccine cannot be disproved." Your Tax Dollars Moody tells IB News, “It’s your tax dollars at work”. “Marginalizing parents as 'hostile' and 'non-professionals' my jaw hit the floor, I was shocked. It’s entirely appropriate to be a responsible critic and a concerned parent worried about vaccine safety. Bernadine Healy (former head of the National Institutes of Health), is an example without being labeled a ‘hostile parent’. Parents have a common interest in healthy children. It’s insulting."
General agreement is that until long-term, double-blind placebo controlled trials are undertaken to compare vaccinated children with unvaccinated children, the cause of autism will remain a mystery. Vaccine additives such as thimerosal (preservative), and aluminum, the use of live viruses in the shot, and the scheduling of vaccines close together have on children are all suspected.

What is the CDC doing to track the epidemic cases of autism? The “CDC does not have complete adverse events surveillance data on which to base health messages” the draft says. “Until you’ve done the study health of unvaccinated children you can’t make any claim,” says Moody. The attorney points out that public doubt is growing over government safety assurances of all vaccines. As federal assurances continue to downplay a link between childhood vaccines and autism, the National Vaccine Injury Compensation Program (VICP) has been quietly paying vaccine injury claims for several years. “They used to say vaccines are safe, now they say vaccines save lives,” Moody says. “The definitive studies of vaccinated versus non-vaccinated children have never been done and data comparing the two groups has not been collected. Instead, a 'safety first' program of sound science has been replaced with an aggressive public relations approach," he says.


 

Diseased African Monkeys Used to Make Swine Flu Vaccines; Private Military Contractor Holds Key Patents

Wednesday, August 05, 2009 by: Mike Adams, the Health Ranger, NaturalNews Editor
Key concepts: Swine flu, Patents and Vaccines
View on NaturalPedia: Swine flu, Patents and Vaccines

(NaturalNews) To most people, vaccines sound medically harmless. "They're good for you!" say the doctors and drug companies, but they never really talk about what's in those vaccines. There's a good reason for that: If people knew what was really in those vaccines, they would never allow themselves to be injected with them.

Aside from the dangerous ingredients many people already know about (like squalene or thimerosal), one of the key ingredients used in flu vaccines (including the vaccines being prepared for the swine flu pandemic) is the diseased flesh of African Green Monkeys. This is revealed in U.S. patent No. 5911998 - Method of producing a virus vaccine from an African green monkey kidney cell line. ( http://www.patentstorm.us/patents/5911998/claims.html)

As this patent readily explains, ingredients used in the vaccine are derived from the kidneys of African Green Monkeys who are first infected with the virus, then allowed to fester the disease, and then are killed so that their diseased organs can be used make vaccine ingredients. This is done in a cruel, inhumane "flesh factory" environment where the monkeys are subjected to a process that includes "incubating said inoculated cell line to permit proliferation of said virus." Then: "harvesting the virus resulting from step (c); and... (ii) preparing a vaccine from the harvested virus."

Aside from the outrageous cruelty taking place with all this ("incubating" the virus in the kidneys of living monkeys, for example), there's another disturbing fact that has surfaced in all this: The patent for this process is held not just by the National Institutes of Health, but by another private corporation known as DynCorp.

This, of course, brings up the obvious question: Who is Dyncorp? And why do they hold a patent on live attenuated vaccine production using African Green Monkeys?



What you probably didn't want to know about Dyncorp
DynCorp, it turns out, is a one of the top private military contractors working for the U.S. government. In addition to allegedly trafficking in under-age sex slaves in Bosnia ( http://www.corpwatch.org/article.php?id=11119) and poisoning rural farmers in Ecuador with its aerial spraying of Colombian coca crops ( http://http://www.corpwatch.org/article.php?id=1988), Dyncorp just happens to be paid big dollars by the U.S. government to patrol the U.S. / Mexico border, near where the H1N1 first swine flu virus was originally detected.

DynCorp also happens to be in a position to receive tremendous financial rewards from its patents covering attenuated live viral vaccine harvesting methods, as described in four key patents jointly held by DynCorp and the National Institutes of Health:

(6025182) Method for producing a virus from an African green monkey kidney cell line

(6117667) Method for producing an adapted virus population from an African green monkey kidney cell line ( http://www.patentstorm.us/patents/6...)

(5911998) Method of producing a virus vaccine from an African green monkey kidney cell line

(5646033) African green monkey kidney cell lines useful for maintaining viruses and for preparation of viral vaccines



Government collusion?
One of the key inventors in these patents now held by DynCorp was Dr. Robert H. Purcell. Who is Dr. Robert Purcell? He's one of the co-chiefs of the Laboratory of Infectious Diseases of the National Institute of Allergy and Infectious Diseases operating under the National Institutes of Health of the U.S. government. ( http://www3.niaid.nih.gov/labs/aboutlabs/lid)

That office, located at 50 South Drive, Bethesda, MD 20892, is less than 15 miles away from the headquarters of DynCorp.

It's not too many more miles to Washington D.C., where U.S. government health authorities awarded over $1 billion in swine flu vaccine contracts to pharmaceutical companies. Can you guess which company received one of the largest vaccine manufacturing contracts? Baxter Pharmaceuticals, the very same company using ingredients derived from African Green Monkeys in precisely the way described in the patents held jointly by DynCorp and the NIH. Remember, Baxter is the company that was caught inserting live viruses into vaccine materials distributed to 18 different countries.

Are you following all this?

So far, we have the U.S. government awarding swine flu vaccine manufacturing contracts to a major U.S. vaccine manufacturer (Baxter) that uses vaccine ingredients from African Green Monkeys (sick!), derived from a process covered in a patent invented by U.S. government NIH researchers (Dr. Purcell and others) and now held jointly by the NIH and a private military contractor named DynCorp -- the very same company that's paid to monitor the U.S. / Mexico border where H1N1 swine flu first appeared.

And just today, there's yet another development in all this: A Tamiflu-resistant strain of swine flu has just been discovered. Care to guess where? On the U.S.-Mexico border ( http://www.google.com/hostednews/afp/article/ALeqM5gZLouahbIkDtadGE3KnYOs5DuTtA).

Once you understand all this, some obvious questions come to mind: Could H1N1 swine flu have been intentionally created and released into the wild (in Mexico) in order to create a windfall of vaccine profits that would financially benefit both the drug companies and the vaccine production patent holders? Because it certainly appears that a grand conspiracy between the NIH, the vaccine makers and private military contractors could have pulled this off.

But wait: Would a private military contractor really resort to such tactics just to make money?

Decide for yourself. Dyncorp has already been accused of crimes against humanity and genocide ( http://www.corpwatch.org/section.php?id=18). According to the Wikipedia page on Dyncorp: ( http://en.wikipedia.org/wiki/DynCorp_International)

Since the late 1990s, the United States has paid private contractors an estimated $1.2 billion, both to eradicate coca crops and to assist the Colombian army put down rebels that use the illegal drug trade to finance their insurgency. DynCorp has been awarded under competitive bid more of this business than any other company. In September 2001, a group of Ecuadorian farmers filed a class-action lawsuit against DynCorp under the Alien Tort Claims Act (ATCA), the Torture Victim Protection Act and state law claims in US federal court in the District of Columbia. The plaintiffs claimed that from January to February 2001 DynCorp sprayed the herbicide almost daily, in a reckless manner, causing severe health problems (high fever, vomiting, diarrhea, dermatological problems) and the destruction of food crops and livestock of approximately 10,000 residents of the border region. In addition, the plaintiffs alleged that the toxicity of the fumigant caused the deaths of four infants in this region. The plaintiffs alleged under ATCA that DynCorp’s intensive aerial spraying of a toxic fumigant amounted to torture, a crime against humanity and cultural genocide.

And on the issue of DynCorp's people engaging in the sex slave trade:

According to whistleblower Ben Johnston, a former aircraft mechanic who worked for [DynCorp] in Bosnia, employees and supervisors of a predecessor company to today's DynCorp International engaged in sex with 12 to 15 year old children, and sold them to each other as slaves.

On June 2, 2000, members of the 48th Military Police Detachment conducted a sting on the DynCorp hangar at Comanche Base Camp, one of two U.S. bases in Bosnia, and all DynCorp personnel were detained for questioning. CID spent several weeks working the investigation and the results appear to support Johnston's allegations. For example, according to DynCorp employee Kevin Werner's sworn statement to CID, "during my last six months I have come to know a man we call 'Debeli,' which is Bosnian for fat boy. He is the operator of a nightclub by the name of Harley's that offers prostitution. Women are sold hourly, nightly or permanently."

Could this same company -- which admittedly sprays poison on family farms in Colombia and Ecuador -- have engaged in another crime against humanity with the release of swine flu virus in Mexico?



Important questions that need to be asked (and answered)
This apparent conspiracy brings up several important questions that need to be answered:

1) Why are key viral vaccine patents jointly held by the NIH and a large private military contractor?

2) Given the atrocious vaccine material handling safety record of Baxter Pharmaceuticals, why did the U.S. government choose Baxter to manufacture vaccines for public consumption?

3) Why is no one talking about the African Green Monkeys who are infected, incubated and then killed for harvesting vaccine ingredients used in the swine flu vaccine?

4) Is it just coincidence that the swine flu virus (and now the Tamiflu-resistant mutation of the virus) first appeared at the U.S. / Mexico border near where DynCorp has a security presence?

5) Why would the inventors of a key vaccine technology agree to hand over ownership of the patent to a private military contractor like DynCorp?

6) Why has nobody in the mainstream media noticed any of this yet (or not bothered to report on it?)

7) How much money is DynCorp collecting on the vaccine patents due to the sudden large-scale manufacture of swine flu vaccines taking place right now?

8) Why does the U.S. government continue to do business with criminally-minded organizations and incompetent vaccine manufacturers?



The pieces of the puzzle (opinion)
It's difficult to consider all the evidence presented here and not come to the rational conclusion that something sinister is afoot in America today. Let me paint a picture for you of a plausible scenario of what I think is happening right now. Note, carefully, that this is merely speculation, but it's a theory that makes sense:

Back in the late 1990's, evil leaders of the U.S. government decided they needed to launch a covert population control measure that could reduce the population while deflecting blame for the deaths. The obvious choice for this was a viral pandemic, so using the viral samples and knowledge already attained by U.S. Army virologists, they engineered a combination swine / avian / human influenza virus patterned after the 1918 influenza that devastated the world population nearly a century ago. The plan, of course, would be to release the virus into the wild and let nature do the rest.

But killing off a lot of people isn't profitable enough all by itself. The plan is a lot smarter if you add a profit center to it... and that's where the vaccines come into play. First, the patents had to be secured in order to guarantee profitability. DynCorp was offered partial ownership of the patents (together with the National Institutes of Health) in exchange for its responsibility to covertly release the engineered virus in Mexico, assuring the global spread of the next influenza pandemic. It will be paid back in patent royalties from the pharmaceutical companies that are awarded the government-funded vaccine manufacturing contracts.

Baxter was chosen by the U.S. government precisely because of its expertise in inserting live viruses into vaccine materials. And just to make sure the drug companies would play along, the U.S. government (under the Bush administration) granted them all complete immunity against product liability for all vaccines. This removed any financial risk from the drug companies while setting the stage for a massive human die-off following the vaccine injections.

Once the injections begin and people start dying, the deaths will simply be blamed on the virus itself. The drug companies have complete legal immunity, and DynCorp gets its share of the profits as the holder of the patents. Key conspirators are rewarded with bonus stock options and / or the threat of being killed if they talk.

Through this plan, several important things are accomplished:

1) The population gets reduced (with no blame on the national leaders).

2) Billions of dollars get funneled to powerful corporations.

3) The pandemic outbreak itself allows government to declare a State of Emergency where yet more rights and freedoms can be stolen away from the People. (And companies like DynCorp can be hired to run domestic prison camps or "isolation camps.")

4) The government and the pharmaceutical industry both get to position themselves as "heroic" for apparently attempting to stop the pandemic with vaccines. No matter how many people actually die, Big Pharma will claim many more would have died without the vaccine.

5) Those who survive the pandemic (and the vaccine) become immune compromised due to the vaccine, and they later emerge as repeat customers for future medical procedures (cancer, Parkinson's, etc.).

Of course, this is all just a theory. Some people might even call it a paranoid theory. But I ask them one question: Why does a top U.S. military contractor share ownership of key vaccine patents with the U.S. government's National Institutes of Health?

Merely attempting to explain that will lead you down the path to all kinds of eye-opening information about collusion between government, the pharmaceutical industry and the military-industrial complex. And you know what they all have in common? They're all promoters of death.

But it's not enough to just kill you; they want to make money while they're doing it.



Read your history
Finally, I feel the need to preempt the naive critics who will inevitably post comments to this story like, "Corporations and governments would never knowingly harm people for power or profit."

Such naivete is almost not worth responding to, but I'll do it in advance just to be sure: Read your world history. Not only is world history full of examples of governments and corporations knowingly harming people for profit, it could be accurately stated that world history is largely a collection of precisely such things!

Read your Noam Chomsky, or Naomi Klein, or Confessions of an Economic Hit Man by John Perkins. His newest book is a real eye-opener about the way governments really work: The Secret History of the American Empire: The Truth About Economic Hit Men, Jackals, and How to Change the World ( http://www.amazon.com/Secret-Histor...).

Although I can't prove it yet, I believe this current swine flu vaccine push is also part of a grand military-industrial-pharmaceutical conspiracy designed to harm the people while extracting huge profits. Only time will tell if this is an accurate assessment of the current situation.

In the mean time, you may wish to avoid being injected with viral material taken from African Green Monkeys (unless you're some sort of sicko).

Sources for this story include:
Wikipedia:
http://en.wikipedia.org/wiki/DynCor...

Corpwatch.org:
http://www.corpwatch.org/section.ph...

Patentstorm.us:
http://www.patentstorm.us/patents/5...

DynCorp:
http://www.dyn-intl.com

end WP import block

Dr Blaylock’s Solutions To Help Those Forced To Take An A/H1N1 Vaccine Stay Healthy


http://clareswinney.wordpress.com/2009/08/03/dr-russell-blaylock-talks-about-natural-solutions-to-help-if-you-are-forced-to-take-ah1n1-vaccine/#more-2314



This report provides practical information on how to protect yourself if you are unlucky enough to be forced to take an A/H1N1 vaccine.
Dr Russell L. Blaylock, a highly-respected neurosurgeon, who has authored three books on nutrition and wellness, including Health And Nutrition Secrets That Can Save Your Life, recently spoke with Dr Bill Deagle, MD of The Nutrimedical Report about some proven natural, readily accessible solutions that may help deal with the toxic effects of A/H1N1 vaccines.

The excellent hour-long interview can be downloaded from http://gcnlive.com/podcast/nutri_med/pcast.php at 0731091.

Dr Blaylock’s List of suggestions on How to Reduce the Toxic Effects of the A/H1N1 Vaccine, is as follows:
1. Number one on the list says Dr Blaylock, is to bring a cold pack with you and place it on the site of the injection as soon as you can, as this will block the immune reaction. Once you get home, continue using a cold pack throughout the day. If you continue to have immune reactions the following day, have cold showers and continue with the cold press.
2. Take fish oil. Eicosapentaenoic acid (EPA), one of the omega 3 fatty acids found in fish oil supplements, is a potent immune suppressant. If you take high dose EPA you will be more susceptible to infections, because it is a powerful immune suppressant. However, in the case of an immune adjuvant reaction, you want to reduce it. Studies show that if you take EPA oil one hour before injecting a very powerful adjuvant called lipopolysaccharide (LPS), it would completely block the ability of the LPS to cause brain inflammation. Take a moderate dose everyday and more if needed to tame a cytokine storm.
3. Flavonoids are third on the list, namely curcumin, quercetin, ferulic acid and ellagic acid, particularly in a mixture. The curcumin and quercetin in particular have been found to block the ability of the adjuvants to trigger a long-term immune reaction. If you take it an hour before the vaccination, it should help dampen the immune reactions says Dr Blaylock.
4. Vitamin E, the natural form that is high in gamma-E will help dampen the immune reactions and reduces several of the inflammatory cytokines.
5. An important ingredient on the list is Vitamin C at a dose of 1000 mg, taken four times a day between meals. It is a very potent anti-inflammatory and should be taken in a buffered form, not as absorbic acid, says Dr Blaylock.
6. Also use astaxanthin as it’s an anti-inflammatory. According to Dr Blaylock, fatal reactions to vaccines in aboriginal and African children occurred in those who were deficient in carotinoids, like astaxanthin.. It is a good protection against the toxic effect of the vaccine.
7. Likewise, it was found that children who were deficient in zinc had a high mortality rate. Zinc is very protective against vaccine toxicity. (Do not use zinc mixed with copper however, as copper is a major trigger of free-radical generation according to Dr Blaylock).
8. Ensure you avoid all immune-stimulating supplements, such as mushroom extracts, whey protein and beta-glucan.
9. Take a multivitamin-mineral daily one that does nott contain iron. This multivitamin-mineral is to make sure your body has plenty of B vitamins and selenium. Selenium, said Dr Blaylock, is very important for fighting viral infections and it reduces the inflammatory response to vaccines.
10. Magnesium citrate/malate 500 mg of elemental magnesium two capsules, three times a day. (This was not mentioned during the show, but was posted at Dr Deagle’s website, ClayandIron.com).
11. What is very important is vitamin D3, which is the only ‘vitamin’ the body can manufacture from sunlight (UVB). It is a neural hormone, not really a vitamin says Dr Blaylock and helps if you are over-reacting immunologically by cooling down the reaction. Similarly, if you are under-reacting, it helps to boost your immune response. In addition it also protects against microorganism invasion.
Black people and those in colder climates are particularly deficient, so they will almost certainly require supplementation.
Dr Blaylock recommends that following vaccination it will help to keep the immune reaction under control if:
i) All children get 5,000 units a day for two weeks after the vaccine and then 2,000 a units a day thereafter;
ii) Adults get 20,000 units a day after the vaccine for two weeks, then 10,000 units a day thereafter;
iii) And with that adults should take 500-1000 mg of calcium a day and children under the age of 12 years should take 250 mg a day, as vitamin D works more efficiently in the presence of calcium.
12. Ensure you avoid all mercury-containing seafood or any other sources of mercury, as the heavy metal is a very powerful inducer of autoimmunity, is known to make people more susceptible to viral infections and will be in H1N1 vaccines.
13. Avoid the oils that significantly suppress immunity and increase inflammation - such as corn, safflower, sunflower, soybean, canola and peanut oils.
14. Drink very concentrated white tea at least four times a day. It helps to prevent abnormal immune reactions.
15. Pop parsley and celery in a blender and drink 8 ounces of this mixture twice a day. Dr Blaylock says the parsley is very high in a flavonoid called apigenin and that celery is high in luteolin. Both are very potent in inhibiting autoimmune diseases, particularly the apigenin, so go and plant some parsley in your garden now.

ISIS Press Release 17/08/09
Live Attenuated Swine Influenza Vaccine for Children Safety in Question

The live attenuated swine flu vaccine intended for millions of children has dangerous side effects and is genetically unstable, risking generation of new pandemic strains should mass vaccinations go ahead.Prof. Joe Cummins and Dr. Mae-Wan Ho

This report has been submitted to Sir Liam Donaldson, UK Chief Medical

Officer, and to the US Food and Drug Administration Please circulate
widely, with all the hyperlinks included, to your elected
representatives, wherever you are
The swine flu vaccines being prepared for release to combat the current
pandemic will be fast tracked without the usual clinical trials to
ensure their safety. Five different companies were contracted to produce
vaccines worldwide - Baxter International, GlaxoSmithKline, Novartis.
Sanofi-Aventis and AstraZeneca - using a range of technologies from
traditional chicken egg production to cell culture [1] ( Fast-tracked
Swine Flu Vaccine under Fire , SiS 43).
Most of the vaccines will not contain live virus and will be delivered
by injection. However AstraZeneca will produce a genetically engineered
live attenuated vaccine through its global biologics unit, MedImmune,
using cell culture or eggs [2]. The MedImmune vaccine will be used
primarily for children, to be delivered as a nasal spray. The nasal
spray vaccine against pandemic H1N1 influenza has been fast tracked for
global distribution [3].
The live-attenuated vaccine appears more effective than the inactivated
virus vaccine, but it resulted in significantly higher rates of severe
adverse events. Furthermore, there is evidence that the live vaccine is
highly genetically unstable in warm body cells and that has not been
thoroughly evaluated in the children vaccinated .
Live attenuated versus inactivated influenza vaccine
MedImmune sponsored a safety and efficacy trial of the nasal spray live-
attenuated, cold adapted (see below) influenza vaccine compared with
inactivated vaccine on infants and young children 6 to 59 months of age
[4]. . The study was conducted at 249 sites in 16 countries; US (49
percent of subjects), 12 countries in Europe and Middle East (45
percent), and 3 countries in Asia (6 percent).
A total of 7852 children completed the study. The results showed that
there were 54.7 percent fewer cases of culture-confirmed influenza in
the group that received live attenuated vaccine than in the group that
received inactivated vaccine (153 cases, 3.9 percent vs 338 cases, 8.6
percent). For all culture-confirmed symptomatic influenza (both vaccine
and non-vaccine strains), the overall attack rates were 5 percent in the
group that received live attenuated vaccine and 10.0 percent in the
group that received inactivated vaccine, indicating that neither vaccine
was particularly good at preventing illness from non-vaccine strains.
These results broadly confirm those of a comprehensive review carried
out in 2006-2008, which could not provide safety analysis [5].
It is important to note that the MedImmune study explicitly excluded
children with a history of hypersensitivity to any component of the live
attenuated vaccine or the inactivated vaccine, known immunosuppressive
condition , medically diagnosed or treated wheezing within 42 days
before enrolment, a history of severe asthma , body temperature higher
than 37.8 C within 3 days before enrolment and the use of aspirin or
salicylate-containing products within 30 days before enrolment. The
conditions italicized are precisely those considered especially at risk
from swine flu and identified as ?priority groups' for receiving the
vaccine by the UK government, which intends to vaccinate the entire UK
population starting in October [6], and there is already evidence that
the inactivated flu vaccine tripled the risk of severe events in
children with asthma [7]. These findings are confirmed in the Medimmune
study, which exposes the highly inadequate safety considerations in the
UK government's mass vaccination programme.
The results showed that among previously unvaccinated children, wheezing
within 42 days after the administration of dose 1 was more common with
live attenuated vaccine, primarily among children 6 to 11 months of age,
which had 12 more episodes of severe wheezing (3.8 percent, compared
with 2.1 percent, p=0.076). Furthermore, rates of hospitalization for
any cause during the 180 days after vaccination were significantly
higher among the recipients of live attenuated vaccine who were 6 to 11
months of age (6.1 percent compared with 2.6 percent, p = 0.002).
The authors stated [4, p. 694]:?Until additional data are available, the
observations related to medically significant wheezing and rates of
hospitalization will restrict the use of live attenuated vaccine in
children younger than 1 year and in children 12 to 47 months of age who
have a history of asthma or wheezing.?
With that proviso, perhaps, they concluded that an ?evaluation of the
risks and benefits indicates that live attenuated vaccine should be a
highly effective, safe vaccine for children 12 to 59 months of age who
do not have a history of asthma or wheezing
Immunizing school children finds favour with governments because it
provides herd protection for the population and is considered more
effective than immunizing elderly and high risk patients [8]. The
MedImmune nasal live attenuated influenza vaccine for seasonal and
pandemic influenza is called FluMist.
Producing live attenuated influenza vaccine
Influenza virus infection depends on two genes coding for haemagglutinin
(HA) and neuraminidase (NA). HA and NA are on the surface of the virus,
and are therefore targets for vaccination. Because classical
reassortment methods (see [1]) for producing influenza vaccine are
time-consuming and cumbersome, a new , more efficient and faster
?reverse genetics? method was devised that assembles RNA virus from the
genes on DNA plasmids. For vaccine production, eight plasmids
-containing the HA and NA genes from pathogenic influenza strains plus
six genes from a non pathogenic master strain - along with additional
plasmids encoding proteins necessary for replication and transcription,
are transfected into cell lines [9]. Virus can then be harvested from
these cells for the production of inactivated or live attenuated
vaccine. ` Live attenuated influenza vaccine (LAIV) was originally
derived by cold adaptation of an influenza type A strain by serial
passage at sequentially lower temperatures in chick kidney cells. During
that process, multiple gene mutants were selected for cold adapted (ca),
temperature sensitive (ts) and attenuated (att) phenotypes of master
donor viruses (MDVs). The MDVs represent the live attenuated virus
backbone that are updated for annual influenza or pandemic influenza HA
and NA genes from disease strains The vaccine seed strain selected in
the process is then used to produce quantities of live attenuated
vaccine. No preservatives are added to the vaccine produced from the
vaccine seed strain [10].
The Madin-Darby canine kidney (MDCK) cell line was chosen to produce
quantities of live attenuated influenza vaccine (LAIV). The MDCK cell
line was compared with the Vero cell line derived from kidney epithelial
cells of the African green monkey and other cell lines derived from
foetal lungs of humans or Rhesus monkey. Both MDCK and Vero cell lines
supported high level production of LAIV for some strains of the virus
while the other cell lines were less productive. However, only the MDCK
cells produced quantities of all of the LAIV strains [11].
Problem with genetic instability of LAIV
LAIV replicates primarily in the ciliated epithelial cells of the
nasopharyngeal mucosa to induce mucosal immune responses. LAIV viruses
do not replicate well at the warmer temperatures found in the lower
airways and lung. In the course of replication, all LAIV viral proteins
would be presented to the immune system in their native conformation and
the resultant immune responses mimic those of natural infection with
influenza virus [10].
A potential problem was observed in studies of LAIV as it encounters
restrictive temperature in the lung. The viral polymerase function is
reduced and virus replication, assembly, and release become impaired
[12]. The morphology of the temperature restricted virus was affected
and the virus particles contained high levels of heat shock protein.
Impairment of the viral replicase is a matter of concern because
replicase may create new pandemic strains. Restrictive replication of
LAIV at the restrictive temperature occurs in multiple steps in the
virus replication cycle [13]. Shedding of LAIV is observed in
individuals between 5 to 49 years of age up to 11 days after
vaccination, and vaccinated individuals were advised to avoid contact
with severely inmunosuppressed individuals for a week after vaccination
[14].
Millions of children may soon be vaccinated with LAIV. But there is a
large deficit in scientific studies on the molecular biology of LAIV
exposed to restrictive temperature. The restricted viruses are
genetically unstable and may result in gene alterations that serve to
seed pandemic strains of influenza. This possibility must be thoroughly
investigated before we expose millions more people to such live viruses.
References
Ho MW and Cummins J. Fast-tracked swine flu vaccine under fire ISIS
Report 27/07/09
http://www.i-sis.org.uk/fastTrackSwineFluVaccineUnderFire.php ; also SiS
43 (in press).
MedImmune pandemic flu vaccine 2009
http://www.medimmune.com/pipeline/pipeline_phase1_detail.asp
MedImmune making significant progress in development of live attenuated
nasal spray vaccine for novel influenza A (H1N1) 2009,
http://www.medimmune.com/h1n1.asp
Belshe RB, Edwards KM, Vesikari T, Black SV, Walker RE, Hultquist M,
Kemble G, Connor EM; CAIV-T Comparative efficacy study group. Live
attenuated versus inactivated influenza vaccine in infants and young
children. N Engl J Med 2007, 356(7), 685-96.
Jefferson T, Rivett A, Harnden A, DiPietrantoni C, and Demicheli V.
Vaccines for preventing influenza in healthy children (Review). Cochrane
Database Systematic Review 23 April 2009,
http://mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004879/pdf_fs.html
?Swine flu latest from the NHS?, NHS choices, 13 August 2009,
http://www.nhs.uk/news/2009/04April/Pages/Swineflulatest.aspx
Flu vaccination may triple risk for flu-related hospitalization in
children with asthma, 25 May 2009,
http://www.medscape.com/viewarticle/703235
Glezen WP Universal influenza vaccination and live attenuated influenza
vaccination of children. Pediatr Infect Dis J 2008, 27(10 Suppl), S104-9.
WARF Improved reverse genetics method to produce influenza virus, 2009
http://www.warf.org/technologies.jsp?techfield=Pharmaceuticals&msnum=885&casecode=P04379US
Ambrose CS, Luke C, Coelingh K. Current status of live attenuated
influenza vaccine in the United States for seasonal and pandemic
influenza. Influenza Other Respi Viruses 2008, 2(6), 193-202.
Liu J, Shi X, Schwartz R, Kemble G. Use of MDCK cells for production of
live attenuated influenza vaccine. Vaccine 2009 Jun 24. in press
doi:10.1016/j.vaccine.2009.06.024
Chen Z, Aspelund A, Kemble G, Jin H.Molecular studies of
temperature-sensitive replication of the cold-adapted B/Ann Arbor/1/66,
the master donor virus for live attenuated influenza FluMist vaccines.
Virology 2008, 380(2), 354-62.
Chan W, Zhou H, Kemble G, Jin H. The cold adapted and temperature
sensitive influenza A/Ann Arbor/6/60 virus, the master donor virus for
live attenuated influenza vaccines, has multiple defects in replication
at the restrictive temperature. Virology 2008, 380(2), 304-11.
Block SL, Yogev R, Hayden FG, Ambrose CS, Zeng W, Walker RE. Shedding
and immunogenicity of live attenuated influenza vaccine virus in
subjects 5-49 years of age. Vaccine. 2008, 26(38), 4940-6.