Chiron: Vaccine License Suspended - Doubts Over Flu And Meningococcal Vaccines
According to a report of BBC News, the manufacturing license of vaccine maker Chiron has been suspended for three months, making it impossible for the manufacturer to sell its Fluvirin vaccine in the "flu season" of this coming winter. There may be a severe shortage in the wings for the US flu vaccine market.
Last year, the nasal-application FluMist vaccine was launched with a big promise and a high price, but turned out to be a flop. Sales were less than expected. Also the generally available injectable vaccine's usefulness was questioned by experts and despite heavy promotion, sales generally fizzled amid questions over the safety and usefulness of the jabs.
But Chiron Corporation is not only supplying flu vaccines. The company is currently involved in a 200 million $ contract with the New Zealand health authorities to supply a meningococcal vaccine for a mass vaccination program expected to cover more than a million children in that country. The vaccine is highly experimental and next to nothing is known about its side effects, but NZ health authorities are telling the population "not to worry". Investigative journalist Jonathan Eisen has done a remarkable job documenting the New Zealand meningococcal vaccine's potentially hazardous profile citing Chiron's own data sheets. His article is contained in a special issue of "What Your Doctor Will Never Tell You", which can be downloaded in PDF format here...
What Your Doctor Will Never Tell You
This 24 page publication documents the New Zealand menongococcal vaccine scandal, which could be a repeat of what happened four years ago in the UK, where a meningitis C vaccine made by Chiron caused several deaths that were covered up by the health authorities "for fear of panicking parents".
The New Zealand publication also pulls together a wealth of highly interesting vaccine information that any concerned parent should know. I recommend you download and read the file.
One of the articles cited, written by Dr. Mike Godfrey, is particularly interesting and documents the connection of meningococcal "infection" and lack of vitamin C, a common nutrient that seems deficient in a sizeable proportion of populations world wide.
Godfrey, in the article titled Meningitis – or Scurvy? says:
The features of meningococcal sepsis include a severe capillary leak syndrome and disseminated intravascular coagulation or clots. It is possible that this could effectively be acute haemorrhagic scurvy and eminently amenable to appropriate therapy. The 1940-70s literature supports this with parenteral ascorbic acid (AA) capable of destroying diphtheria, tetanus, salmonella, gas gangrene (clostridium) and meningococcal endotoxins.Prof. Clemetson's 1989 3 volume texbook on Vit.C showed why bacterial toxin-induced mortality increases with AA depletion. Other researchers have confirmed that non-survivors from meningitis having oxidised whatever AA reserves they had to neutralize bacterial toxins, suffered acute, lethal scurvy.
AA levels in the spinal fluid of meningitis patients has been negatively correlated with the outcome of patients with bacterial meningitis and thus, its depletion also may be an indicator of a bad prognosis.
Up to 15% of the population may be scorbutic (below 0.2mg/100ml serum) and thus at increased risk of bacterial endotoxin toxicity as would many of the impoverished and nutrient-deficient South Auckland populations. The latent scorbutic state can then be converted into frank scurvy by infections (and even vaccines), and under such conditions hemorrhagic phenomena are frequent. All of the patho-physiological features of haemorrhagic and thrombotic conditions found in bacterial meningitis are seen in AA deficiency states.
It could therefore surely be appropriate to administer this safe and cheap therapy concurrently with antibiotics to everyone suspected of this disease. Indeed, it is possibly only when the liver is overwhelmed by bacterial toxin that a fulminating haemorrhagic disease ensues.
It would appear thus that meningococcal disease is both eminently preventable and even curable by simply supplying sufficient amounts vitamin C, a nutrient which is of great importance for health but which human bodies cannot manufacture, to those suffering from the infection or who might be at risk of contracting it.
Godfrey also mentions in his article that the "epidemic" apeared to be already well on its way out and that the number of cases had been sharply reduced in the years prior to the all-out vaccination drive of the New Zealand health authorities.
This is has also been documented by another New Zealand based researcher, Ron Law, who put the statistics together and who provides a comment, blasting the health minister's obvious disregard for real data on disease incidence. Here is the information provided by Law's Beyond Alternative Solutions:
"If the Ministry of Health wants to be taken seriously by the public and politicians, then it has to be honest in its risk communications," says risk and policy analyst, Ron Law (09-832 4773)."Why is the Mystery of Health not celebrating the fact that there has been a natural 75% decrease in deaths and a 49% decrease in the number of meningococcal disease cases since the epidemic peaked in 2001?" asks Ron Law.
"Could it be that promulgating these stunning facts might mean less political and public enthusiasm for its MeNZB campaign? Or maybe it is because it will be impossible for the Ministry to claim any success for its MeNZB campaign in the future if the public and politicians knew the truth?"
The Ministry of Health has announced the completion of the first 100,000 vaccinations with its experimental MeNZB vaccine. Given its target of reaching 1.15 million New Zealanders, and given that three vaccinations are required to achieve the 75% immune response rate desired, that means that the programme has completed less than 3.3% of its target in terms of vaccinations given.
Comparing the Ministry's Meningococcal Disease Update Week 38: 11/09/2004 to 17/09/2004, to week 38 reports for 2001, 2002, and 2003, there has been a steady decline in the number of cases and and an even more dramatic decline in the number of deaths due to meningococcal B disease since the peak in 2001.
It is noted that the MOH is using total Meningococcal disease to wage its PR campaign against a particular strain of Meningococcal bacteria. Based on MOH information, in 2003 71.5% of laboratory confirmed cases were caused by the strain that the vaccine is designed to protect against. The following data are adjusted accordingly.
Year / Cases / Decline (%) / Deaths / Decline (%)2001 .. 315 ......................... 16
2002 .. 309 .... 2% ................ 9 ......... 43%
2003 .. 293 .... 7% ................ 6 ......... 63%
2004 .. 161 .... 49% .............. 4 ......... 75%* Note: Decline percentages as given are cumulative.
Based on Ministry of Health advice, Health Minister Annette King falsely stated in July 2004 that, "The epidemic has shown no signs of abating..." Why was the Minister misled by her officials?In its euphemistically called, 'Fact Sheet number 1," the Ministry of Health said, "Rates of disease are still at peak levels and the epidemic is expected to last at least another 10 years if there is no vaccine developed."
"This statement, masqueraded as fact, is clearly scientifically false and one can only surmise as to why the Ministry of Health would knowingly mislead both the Minister and the public by making such false statements," says Ron Law.
The evidence is speaking for itself. There is clearly no scientific basis for continuing the MeNZB programme; it should be suspended forthwith.
This is important to not only protect the wellbeing of 1.15 million New Zealanders at risk, but perhaps even more importantly, to protect the credibility of important future public health initiatives.
The New Zealand example is by no means unique. Many vaccines claim successes in combatting disease that were not due to the vaccine but rather to accompanying (and many times ongoing for years before) reduction of infections by improvements in basic sanitation and nutrition.
The record is further skewed by the fact that vaccine adverse reactions are not systematically reported and collected, hiding many of the long term adverse effects that vaccines are increasingly being linked to, such as diabetes, heart trouble, cancer and developmental problems - autism and ADHD.
See also related:
Warning to flu vaccine maker releasedDramatic Meningococcal Decline Continues
Graphic of meningococcal disease deaths since 1997 - by Ron Law
Download fileGraphic of meningococcal cases from 2001 peak to 2004 - By Ron Law
Insight: The Biology Of A Meningococcal Vax Company
Thursday, 11 November 2004 - By Barbara Sumner Burstyn and Ron Law
Chiron Corporation. Does that name a ring a bell? In North America, itÃs gone from barely known to highly recognized in less than a month since 45 million doses of flu vaccine made by the company in its British factory, were found to be contaminated. In Brazil the company made headlines when over 5 million doses of a vaccine were recalled following serious adverse reactions.Polio Vaccine Voodoo - Intriguing Questions
The Avian Flu and Drugless Doctors
CDC Knew: Mercury in Vaccines Induces Autism
Flu Experts: Vaccine Effectiveness 'not demonstrated'
Medical Veritas: 'Tragic Consequences' of Childhood Vaccinations
Annual Number of flu deaths: it's a guess
A recent BBC article: US scientists are genetically modifying the flu virus to make it as virulent as the 1918 flu - The new strain could be deadly - A new flu pandemic is overdue. Put that together with the fact of cutting in half the flu vaccines available to the US, and confidently predict the "outbreak" of a killer epidemic this winter.
Killer flu recreated in the lab
Scientists have shown that tiny changes to modern flu viruses could render them as deadly as the 1918 strain which killed millions - Some experts believe a flu pandemic is overdueThe Globe and Mail: Scientists create 'cousin' of 1918 killer flu
By CAROLYN ABRAHAM, MEDICAL REPORTER - Thursday, October 7, 2004
Behind the thick-walled confines of Canada's National Microbiology Laboratory in Winnipeg, scientists have created from scratch a creepy cousin of the 1918 pandemic flu virus, the deadliest plague in historyUSA got improperly made flu vaccine
By Julie Schmit, USA TODAY
The British plant responsible for the recent flu vaccine shortage sent some improperly made vaccine, by mistake, to U.S. consumers three years ago, according to a 2003 government inspection report recently given to Congress.Contamination hits 2nd flu vaccine supply
By UNITED PRESS INTERNATIONAL
July 21, 2005 NEW YORK -- Already plagued by production cutting contamination problems, Chiron Corp. now says it will not be able to make or sell flu vaccine at all this year. Less than a week after announcing a production cutback, Chiron said testing at its plant in Marburg, Germany, showed that bacterial contamination of its Begrivac vaccine was more widespread than previously believed, prompting a halt of all shipments this year.
See also this comment by Jon Rappoport of www.nomorefakenews.comCHIRON FORCED TO DUMP FLU VACCINE
OCTOBER 6, 2004. Bam! Chiron Corp.'s flu vaccine has been deemed unsafe and contaminated by both British and US regulators...therefore the company, which was on the verge of shipping 48 million doses to America for the upcoming "flu season," has had to shut down its facility in England and dump all the vials of vaccine.
Major point: the vials were already made and ready to go; this tells you how much faith to put in statements from vaccine manufacturers about the wonderful purity of processing in their plants.
Also, with the US unable to deliver about half the expected flu shots this fall, the CDC will be scrambling to deliver dire reports about flu spreading in the US as we head into the winter. Why? Because if the flu season turns out to be light (like last year), people will begin to catch on: the flu shots are not useful, are not necessary.
Look for: "It's a terrible flu that's going around this year. People are dropping like flies. And all because we couldn't get enough vaccine out there."
Of course, this shortfall of shots will enable the PR people for US health agencies to pump up (invent) the "crying demand" on the part of the public for their jabs.
"You don't have enough medicine? O my God. Give me mine! And what about THE CHILDREN??!"
This is ALL PR crapola of the worst kind. When people do well at staying healthy and strong, they don't need gallons of meds.
BOSTON (CBS.MW) -- British regulators' sudden move to shut down Chiron's flu shot manufacturing operations sent the company's shares tumbling, while fanning fears the United States could be vulnerable to an influenza epidemic.
Chiron (CHIR: news, chart, profile) rocked investors Tuesday when the company said it will not be able to release any of its Fluvirin vaccine because the British government has suspended the manufacturing license at its Liverpool plant for at least three months.
The plant is Chiron's only flu-shot manufacturing facility. The suspension only prohibits Chiron from making Fluvirin at Liverpool, and does not affect the production of other products there, the company said.
In addition, the British government also is preventing manufactured doses of the vaccine to be shipped to the United States.
Shares of the vaccine developer closed down 16.38 percent to $37.98 Tuesday. Chiron had halted trading of its shares until about 12.15 p.m. Eastern and was down by more than a third at one point after trading resumed.
Chiron is one of only two major suppliers of seasonal flu vaccine to the U.S. market. The Emeryville, Calif.-based biotechnology firm planned to supply 46 million to 48 million doses of the vaccine for the 2004-05 flu season, which begins in October. The other major supplier, Sanofi-Aventis (SNY: news, chart, profile), is reportedly on track to supply 50 million doses.
Chiron's flu vaccine is only approved for use in adults. Pediatric flu shots are supplied by Aventis, according to the U.S. Health and Human Services Department.
"We profoundly regret we will be unable to meet public health needs," said Chiron Chief Executive Howard Pien in a conference call with investors midday Tuesday.
"The suspension ... has the practical effect of wiping out our ability to supply," he added.
According to Chiron management, the Medicines and Healthcare Products Regulatory Agency, or MHRA, Britain's equivalent to the U.S. Food and Drug Administration, yanked the company's license to manufacture the vaccine at its Liverpool plant at midnight Eastern time Tuesday, citing concerns about the process.
Chiron already had announced it was delaying shipments of the vaccine after discovering some batches of the vaccine made at the plant had been contaminated.
The company is also a major supplier of the flu vaccine to the British government.
The MHRA's move came just as Chiron was doing final testing on this season's supply. According to Chiron, practically all of the 48 million doses slated for the United States had already been manufactured when the MHRA pulled the plug.
Pien said that the move was "unexpected," maintaining that the flu shots had passed internal corporate inspection without a problem last week, an inspection process that the FDA appeared to be "fairly comfortable with."
"As of last week, we expected to be on track to have delivery of Fluvirin by early October," Pien elaborated on the U.S. shipments. "You should now assume that the entirety of the 2004-05 flu season is gone."
The executive said that the existing supply of flu shots at the Liverpool plant will be destroyed unless MHRA changes its decision in the next few days. He added that Chiron will begin discussions with that agency Wednesday.
Because it takes more than five months to manufacture the vaccine, Pien indicated that there is no way the company can manufacture more of the shots to meet its U.S. obligations.
Chiron also issued new 2004 financial estimates. The company said that due to the loss of its primary product for the year, Chiron now expects to post net earnings of between 35 cents and 45 cents per share for 2004. The company previously forecast earnings of $1.50 to $1.60 a share for the year.
Chiron is one of the world's leading manufacturers of flu vaccines. The company is a major supplier of flu shots to the United States, as well as Germany, Ireland, Italy and the United Kingdom.
It said in August it was delaying U.S. shipments for several weeks after it was discovered that a small number of batches made at its Liverpool plant had been contaminated due to human error. Chiron executives testified before Congress last week that they anticipated no further delays in the shipments.
Sanofi-Aventis is the other major flu vaccine supplier to the United States. The company said Monday that it had already shipped 30 million doses ahead of schedule to U.S. distributors. See related story.
Niche biotechnology concern MedImmune (MEDI: news, chart, profile) also makes a spray-mist version of the vaccine, called FluMist. But that product has not been approved for use in children under age 5 and adults over 50, who combined make up the vast bulk of flu shot recipients.
MedImmune's chief executive told CBS MarketWatch in early September that his company had no plans to ramp up additional production of FluMist to fill any market void created by Chiron's delays. MedImmune had planned to only make about 2 million doses of FluMist for the 2004-05 flu season.
U.S.-traded shares of Sanofi-Aventis rose 0.98 percent to $37.14. Its Aventis (AVE: news, chart, profile) subsidiary, of which 5 percent of its shares are publicly traded, was up 1.39 percent to $86. MedImmune jumped 5.79 percent to $25.78.
During a second press conference Tuesday, Chiron executives also emphasized that the company is still seeking to be a major vaccine supplier for the 2005-06 season. The company said that it is working diligently with U.S. and foreign regulators to help work out any outstanding issues to be able to begin the lengthy manufacturing process next spring.
"What we're worried about is our ability to live up to the public trust... as a reliable supplier of the vaccine," lamented Pien.
He added that the company is also on track with a previously planned $100 million capital investment in its vaccine-making operations, which include construction and upgrades.
End of CBS piece.
JON RAPPOPORT www.nomorefakenews.com
posted by Sepp Hasslberger on Wednesday October 6 2004
updated on Friday December 10 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2004/10/06/chiron_vaccine_license_suspended_doubts_over_flu_and_meningococcal_vaccines.htm
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