Via:Lexology
The 2012-2013 flu season continues to take a toll on the workplace. According to the Centers for Disease Control (”CDC”), this year’s flu season began four weeks earlier than most recent seasons and, as of the week ending March 9, 2013, flu season activity has remained elevated across the United States. Having already taken the lives of 64 children, and with adult numbers unavailable until the end of the flu season, many employers are considering the implementation of mandatory flu vaccination policies. While such policies may serve business and safety needs of protecting their workplace and workforce, employers should ask themselves the following three questions before adopting such a policy:
What are the business needs for implementing the policy?
Prior to implementing a mandatory flu vaccination policy, employers need to carefully evaluate the business and safety needs for the requirement. Whether out of a concern for the safety of patients or customers or the need to ensure an adequate and fully-staffed workplace, an employer needs to be ready to identify these reasonable business interests should an employee or applicant challenge the policy.
Is your workforce unionized?
Under the National Labor Relations Act, flu vaccination policies must be collectively bargained. Accordingly, unionized employers cannot unilaterally impose a mandatory flu vaccination policy without first providing notice to the union and bargaining at the union’s request. Despite this, unionized employers need to carefully evaluate the management rights clause contained in their collective-bargaining agreement. The National Labor Relations Board recently issued an opinion finding that a union waived the right to bargain over a flu vaccination policy by agreeing to the management rights clause in the parties’ collective bargaining agreement. Virgina Mason Hospital, 358 NLRB No. 64 (2012). The Board recognized that this waiver allowed the hospital to require non-immunized nurses to wear face masks.
How will you enforce the policy?
When adopting a mandatory flu vaccination policy, employers must be prepared to address objections raised by their employees. The Equal Employment Opportunity Commission takes the view that employees may be exempt from mandatory vaccination policies based on an Americans with Disabilities Act “disability” or a sincerely held religious belief, practice, or observance. Pandemic Preparedness in the Workplace and the Americans With Disabilities Act (2009). Such sincerely held religious beliefs do not have to be mainstream or widely recognized religions and may include lifestyle choices such as veganism. See Chenzira v. Cincinnati Children’s Hosp. Med. Ctr., No. 1:11-CV-00917, 2012 WL 6721098, at *4 (Dec. 27, 2012)(the court declined to dismiss plaintiff’s religious discrimination claim when her employer terminated her employment after she refused to be vaccinated for the flu on account of her veganism). Despite this expansive definition, the EEOC stated that it is unlikely that religious beliefs include “secular philosophical opposition to vaccination.” EEOC Informal Discussion Letter (Mar. 5, 2012). When an employee raises a health or religious-based objection to the vaccination policy, the employer needs to discuss reasonable accommodations with the employee. Such reasonable accommodations may include entirely excusing the employee from the policy, requiring the employee to wear a protective facemask or temporarily transferring the employee to another position. Employers need not offer these reasonable accommodations if providing them would cause “undue hardship.” In determining whether undue hardship exists, the EEOC found the following factors relevant: (1) the assessment of the public risk posed at a particular time; (2) the availability of effective alternative means of infection control; and (3) the potential number of employees who actually request accommodation. EEOC Informal Discussion Letter (Mar. 5, 2012).
In addition to tackling objections raised by employees, employers need to implement the policy across its workforce uniformly. Employers should not terminate summarily an employee who refuses a flu vaccination without first engaging in a discussion to determine whether the employee is objecting for health or religious based reasons. Furthermore, employers might consider gradual discipline for first-time offenders such as issuing a letter of instruction.
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Apr 19, 2013
Apr 18, 2013
Texas A&M will be home to $91 million vaccine-manufacturing Bio-Weapons Laboratory
Via:statesman
The U.S. Department of Health and Human Services has approved the creation of a $91 million influenza-vaccine manufacturing facility in a joint venture between the Texas A&M University System and GlaxoSmithKline in what Chancellor John Sharp described Tuesday as “one of the most significant developments ever in the state of Texas.”
The facility will speed up the research, development and delivery of vaccines and therapeutics in cases of pandemics or other national emergencies.
The center would also supply preventive vaccine for pandemic influenza, and, once it’s up and running, will be able to supply 50 million vaccine doses within four months of receiving a strain of the flu, with initial doses ready in 12 weeks.
The facility will anchor the Center for Innovation in Advanced Development and Manufacturing in Bryan-College Station, establishing what Sharp characterized as “third coast biopharmaceuticals.” A&M is home to one of only three so-called CIADMS being created in the nation.
“It’s a game-changer not just for Texas but for folks everywhere,” Sharp said at a morning news conference with Gov. Rick Perry to announce the effort.
Perry said the center would bring more than $41 billion in in-state expenditures over the next 25 years and directly and indirectly create more than 6,800 jobs.
“More importantly there will be lives that will be saved around the world because of what is happening in the state of Texas,” said Perry.
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The U.S. Department of Health and Human Services has approved the creation of a $91 million influenza-vaccine manufacturing facility in a joint venture between the Texas A&M University System and GlaxoSmithKline in what Chancellor John Sharp described Tuesday as “one of the most significant developments ever in the state of Texas.”
The facility will speed up the research, development and delivery of vaccines and therapeutics in cases of pandemics or other national emergencies.
The center would also supply preventive vaccine for pandemic influenza, and, once it’s up and running, will be able to supply 50 million vaccine doses within four months of receiving a strain of the flu, with initial doses ready in 12 weeks.
The facility will anchor the Center for Innovation in Advanced Development and Manufacturing in Bryan-College Station, establishing what Sharp characterized as “third coast biopharmaceuticals.” A&M is home to one of only three so-called CIADMS being created in the nation.
“It’s a game-changer not just for Texas but for folks everywhere,” Sharp said at a morning news conference with Gov. Rick Perry to announce the effort.
Perry said the center would bring more than $41 billion in in-state expenditures over the next 25 years and directly and indirectly create more than 6,800 jobs.
“More importantly there will be lives that will be saved around the world because of what is happening in the state of Texas,” said Perry.
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Apr 17, 2013
Does Aluminum Cause Alzheimer's Disease
Via:CCOSH
Can aluminum cause Alzheimer's disease is a controversial question. Alzheimer's disease is the most common cause of senile brain disease and is a fatal and untreatable condition. It begins with learning memory deficits and progresses to involve all aspects of intellectual activity including judgement, calculation and language.
Post-mortem examinations of humans with Alzheimer's disease show that there are high concentrations of aluminum in the brain. However, aluminum normally is not found in healthy brain tissue and researchers do not know how the metal gets into the brain. Some researchers compared the aluminum concentration on brains of subjects affected by Alzheimer's disease and age-matched controls. They found no differences between the two groups, suggesting that elevated aluminum concentration may be associated with age. Experimentally it is proven that aluminum is toxic to nerves in animals but the neuron degeneration is different from what occurs in humans. For more detailed information please see the chemical profile on aluminum powder.
The animals that respond to aluminum treatment with neuron degeneration are rabbits, cats and dogs. If these animals are injected with aluminum salts directly into the brain they show learning memory deficits, become slower and lose curiosity. This picture resembles remarkably certain features of Alzheimer's disease. But the neuron degeneration is not the same as the one seen in Alzheimer's disease.
In conclusion, the cause of Alzheimer's disease is yet unknown and there is no absolute evidence linking aluminum exposure to Alzheimer's disease.
What are the sources of aluminum exposure?
Workers can be exposed to aluminum during production or processing of this metal and its alloys. In addition to workplace exposure, people can come into contact with aluminum in many other ways.
Aluminum is found in food, drinking water and in some medications. There has been considerable interest and controversy concerning the relationship between aluminum in drinking water and Alzheimer's disease. So far, the results of many studies have been inconclusive and contradictory. It is important to note that the content of this metal in the diet is increased by the use of aluminum and its alloys in the food industry. The cooking and storage of food in aluminum ware might double or even triple the usual daily intake.
Are there exposure limits for aluminum?
In the workplace, the American Conference of Governmental Industrial Hygienists (ACGIH) has assigned an occupational exposure limit based on respirable particle size.
The current ACGIH recommended Threshold Limit Value Time-Weighted Average (TLV-TWA) exposure limit for aluminum in the air is 1 mg/m3 for aluminum metal (CAS number 7429-90-5) and insoluble compounds.
Aluminum metal and insoluble compounds of respirable particle size are also categorized by ACGIH for carcinogenicity as A4 - Not classifiable as a Human Carcinogen; inadequate data on which to classify the substance as a human and/or animal carcinogen.
The TLV-TWA is the time-weighted average airborne concentration for a normal 8-hour workday and a 40-hour workweek to which it is believed that nearly all workers may be exposed repeatedly, day after day, without adverse health effects.
In many Canadian jurisdictions, exposure limits are the same as or similar to the ACGIH TLVs. Since the manner in which exposure limits are established, interpreted and implemented can vary, the appropriate government agency in each jurisdiction should be consulted.
Can aluminum cause Alzheimer's disease is a controversial question. Alzheimer's disease is the most common cause of senile brain disease and is a fatal and untreatable condition. It begins with learning memory deficits and progresses to involve all aspects of intellectual activity including judgement, calculation and language.
Post-mortem examinations of humans with Alzheimer's disease show that there are high concentrations of aluminum in the brain. However, aluminum normally is not found in healthy brain tissue and researchers do not know how the metal gets into the brain. Some researchers compared the aluminum concentration on brains of subjects affected by Alzheimer's disease and age-matched controls. They found no differences between the two groups, suggesting that elevated aluminum concentration may be associated with age. Experimentally it is proven that aluminum is toxic to nerves in animals but the neuron degeneration is different from what occurs in humans. For more detailed information please see the chemical profile on aluminum powder.
The animals that respond to aluminum treatment with neuron degeneration are rabbits, cats and dogs. If these animals are injected with aluminum salts directly into the brain they show learning memory deficits, become slower and lose curiosity. This picture resembles remarkably certain features of Alzheimer's disease. But the neuron degeneration is not the same as the one seen in Alzheimer's disease.
In conclusion, the cause of Alzheimer's disease is yet unknown and there is no absolute evidence linking aluminum exposure to Alzheimer's disease.
What are the sources of aluminum exposure?
Workers can be exposed to aluminum during production or processing of this metal and its alloys. In addition to workplace exposure, people can come into contact with aluminum in many other ways.
Aluminum is found in food, drinking water and in some medications. There has been considerable interest and controversy concerning the relationship between aluminum in drinking water and Alzheimer's disease. So far, the results of many studies have been inconclusive and contradictory. It is important to note that the content of this metal in the diet is increased by the use of aluminum and its alloys in the food industry. The cooking and storage of food in aluminum ware might double or even triple the usual daily intake.
Are there exposure limits for aluminum?
In the workplace, the American Conference of Governmental Industrial Hygienists (ACGIH) has assigned an occupational exposure limit based on respirable particle size.
The current ACGIH recommended Threshold Limit Value Time-Weighted Average (TLV-TWA) exposure limit for aluminum in the air is 1 mg/m3 for aluminum metal (CAS number 7429-90-5) and insoluble compounds.
Aluminum metal and insoluble compounds of respirable particle size are also categorized by ACGIH for carcinogenicity as A4 - Not classifiable as a Human Carcinogen; inadequate data on which to classify the substance as a human and/or animal carcinogen.
The TLV-TWA is the time-weighted average airborne concentration for a normal 8-hour workday and a 40-hour workweek to which it is believed that nearly all workers may be exposed repeatedly, day after day, without adverse health effects.
In many Canadian jurisdictions, exposure limits are the same as or similar to the ACGIH TLVs. Since the manner in which exposure limits are established, interpreted and implemented can vary, the appropriate government agency in each jurisdiction should be consulted.
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Apr 16, 2013
Aluminum Vaccine Adjuvant linked to Gulf War illness
Via: PubMed NCBI
Gulf War illness (GWI) affects a significant percentage of veterans of the 1991 conflict, but its origin remains unknown. Associated with some cases of GWI are increased incidences of amyotrophic lateral sclerosis and other neurological disorders. Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene. To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed. Young, male colony CD-1 mice were injected with the adjuvants at doses equivalent to those given to US military service personnel. All mice were subjected to a battery of motor and cognitive-behavioral tests over a 6-mo period postinjections. Following sacrifice, central nervous system tissues were examined using immunohistochemistry for evidence of inflammation and cell death. Behavioral testing showed motor deficits in the aluminum treatment group that expressed as a progressive decrease in strength measured by the wire-mesh hang test (final deficit at 24 wk; about 50%). Significant cognitive deficits in water-maze learning were observed in the combined aluminum and squalene group (4.3 errors per trial) compared with the controls (0.2 errors per trial) after 20 wk. Apoptotic neurons were identified in aluminum-injected animals that showed significantly increased activated caspase-3 labeling in lumbar spinal cord (255%) and primary motor cortex (192%) compared with the controls. Aluminum-treated groups also showed significant motor neuron loss (35%) and increased numbers of astrocytes (350%) in the lumbar spinal cord. The findings suggest a possible role for the aluminum adjuvant in some neurological features associated with GWI and possibly an additional role for the combination of adjuvants.
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Gulf War illness (GWI) affects a significant percentage of veterans of the 1991 conflict, but its origin remains unknown. Associated with some cases of GWI are increased incidences of amyotrophic lateral sclerosis and other neurological disorders. Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene. To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed. Young, male colony CD-1 mice were injected with the adjuvants at doses equivalent to those given to US military service personnel. All mice were subjected to a battery of motor and cognitive-behavioral tests over a 6-mo period postinjections. Following sacrifice, central nervous system tissues were examined using immunohistochemistry for evidence of inflammation and cell death. Behavioral testing showed motor deficits in the aluminum treatment group that expressed as a progressive decrease in strength measured by the wire-mesh hang test (final deficit at 24 wk; about 50%). Significant cognitive deficits in water-maze learning were observed in the combined aluminum and squalene group (4.3 errors per trial) compared with the controls (0.2 errors per trial) after 20 wk. Apoptotic neurons were identified in aluminum-injected animals that showed significantly increased activated caspase-3 labeling in lumbar spinal cord (255%) and primary motor cortex (192%) compared with the controls. Aluminum-treated groups also showed significant motor neuron loss (35%) and increased numbers of astrocytes (350%) in the lumbar spinal cord. The findings suggest a possible role for the aluminum adjuvant in some neurological features associated with GWI and possibly an additional role for the combination of adjuvants.
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Apr 15, 2013
Death of Alzheimer Victim linked to Aluminium Pollution
Via: Nature News
Brain autopsy of pollution victim rekindles contaminant fears.
Fears of a link between aluminium and Alzheimer's disease have been reignited by the case of a British woman who died of the illness 16 years after an industrial accident polluted her local drinking water.
An autopsy on Carole Cross's brain showed that she was suffering from a rare form of early-onset Alzheimer's when she died in May 2004, and also revealed the presence of high levels of aluminium in her tissues. The researchers who investigated her brain cannot say whether the aluminium was the cause, but point out that the woman had no family history of dementia.
The polluting incident occurred in 1988 when a truck driver mistakenly emptied some 20 tonnes of aluminium sulphate — used in the early stages of wastewater treatment — into a tank containing drinking water destined for the village of Camelford in Cornwall, UK. An estimated 20,000 people may have been exposed to high levels of the chemical for several weeks.
Concerned residents are waiting to see whether more people will be similarly affected. Anecdotal reports state that several other villagers are suffering from dementia.
Something in the water
Although only a single case, the discovery has reopened the possibility that aluminium could be linked to Alzheimer's disease, say Christopher Exley, a chemist at Keele University, UK and Margaret Esiri, a University of Oxford neurologist, who publish details of their investigation on Cross in the Journal of Neurology, Neurosurgery and Psychiatry1.
Aluminium is firmly linked to some temporary forms of dementia, Esiri says. Kidney dialysis patients living in areas where water is high in aluminium, for example, sometimes experience 'dialysis dementia', as a result of the large quantities of contaminated water passing through their bodies.
“Once aluminium binds to proteins, it sticks for good. It's like trying to use superglue to mend a Swiss watch.”
Daniel Perl,
Mount Sinai School of Medicine, New York
But the link between aluminium and Alzheimer's has been more controversial, says Daniel Perl, a neuropathologist at Mount Sinai School of Medicine in New York, who has written a commentary on the Camelford case2.
Aluminium is often found in the twists of deformed protein, called 'neurofibrillary tangles', that characterize the disease. But there is no strong evidence that it is involved in the disease's onset, Perl cautions. "I realize that's quite a conservative answer," he says. "But show me a couple more cases like this and I might have to change it."
Perl points out that, of the 20 most common elements on Earth, aluminium is the only one not involved in any essential biological process. That's because of its feisty chemistry, he explains. When in solution, aluminium ions are small and highly charged, making them very reactive. "Once aluminium binds to proteins, it sticks for good," he says. "It's like trying to use superglue to mend a Swiss watch."
What makes Cross's case interesting is that she had succumbed to a very rare form of Alzheimer's, but had a genetic predisposition, through a gene called APOE, to developing a more common form of the disease later in life, says Esiri. This raises the possibility that her aluminium exposure may have accelerated the onset of disease. Previous studies of transgenic mice expressing a similar gene have shown that feeding them aluminium in drinking water can cause similar symptoms at a young age.
Cross's protein tangles were found in the blood vessels rather than in the brain tissue itself. This is consistent with the idea that the cause of the disease could have originated in the gut, reaching the brain through the bloodstream, Esiri explains.
Combined with the unusually young age at which she died (aged 58), this puts her in a category shared by only a handful of known cases worldwide, Esiri says.
The discovery may also rekindle fears over drinking and cooking using aluminium pots and pans, although Perl says that most aluminium is found in an insoluble form and therefore not dangerous. The only way to ingest aluminium would be by cooking acidic foods such as rhubarb or tomato, which would react with the metal.
The news is worrying for Camelford's residents, says Exley, who carried out the chemical analysis to spot the aluminium in the autopsy samples. "There are still 20,000 people thinking about whether they're susceptible to this chronic disease," he says. "We can't do anything to help them."
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Brain autopsy of pollution victim rekindles contaminant fears.
Fears of a link between aluminium and Alzheimer's disease have been reignited by the case of a British woman who died of the illness 16 years after an industrial accident polluted her local drinking water.
An autopsy on Carole Cross's brain showed that she was suffering from a rare form of early-onset Alzheimer's when she died in May 2004, and also revealed the presence of high levels of aluminium in her tissues. The researchers who investigated her brain cannot say whether the aluminium was the cause, but point out that the woman had no family history of dementia.
The polluting incident occurred in 1988 when a truck driver mistakenly emptied some 20 tonnes of aluminium sulphate — used in the early stages of wastewater treatment — into a tank containing drinking water destined for the village of Camelford in Cornwall, UK. An estimated 20,000 people may have been exposed to high levels of the chemical for several weeks.
Concerned residents are waiting to see whether more people will be similarly affected. Anecdotal reports state that several other villagers are suffering from dementia.
Something in the water
Although only a single case, the discovery has reopened the possibility that aluminium could be linked to Alzheimer's disease, say Christopher Exley, a chemist at Keele University, UK and Margaret Esiri, a University of Oxford neurologist, who publish details of their investigation on Cross in the Journal of Neurology, Neurosurgery and Psychiatry1.
Aluminium is firmly linked to some temporary forms of dementia, Esiri says. Kidney dialysis patients living in areas where water is high in aluminium, for example, sometimes experience 'dialysis dementia', as a result of the large quantities of contaminated water passing through their bodies.
“Once aluminium binds to proteins, it sticks for good. It's like trying to use superglue to mend a Swiss watch.”
Daniel Perl,
Mount Sinai School of Medicine, New York
But the link between aluminium and Alzheimer's has been more controversial, says Daniel Perl, a neuropathologist at Mount Sinai School of Medicine in New York, who has written a commentary on the Camelford case2.
Aluminium is often found in the twists of deformed protein, called 'neurofibrillary tangles', that characterize the disease. But there is no strong evidence that it is involved in the disease's onset, Perl cautions. "I realize that's quite a conservative answer," he says. "But show me a couple more cases like this and I might have to change it."
Perl points out that, of the 20 most common elements on Earth, aluminium is the only one not involved in any essential biological process. That's because of its feisty chemistry, he explains. When in solution, aluminium ions are small and highly charged, making them very reactive. "Once aluminium binds to proteins, it sticks for good," he says. "It's like trying to use superglue to mend a Swiss watch."
What makes Cross's case interesting is that she had succumbed to a very rare form of Alzheimer's, but had a genetic predisposition, through a gene called APOE, to developing a more common form of the disease later in life, says Esiri. This raises the possibility that her aluminium exposure may have accelerated the onset of disease. Previous studies of transgenic mice expressing a similar gene have shown that feeding them aluminium in drinking water can cause similar symptoms at a young age.
Cross's protein tangles were found in the blood vessels rather than in the brain tissue itself. This is consistent with the idea that the cause of the disease could have originated in the gut, reaching the brain through the bloodstream, Esiri explains.
Combined with the unusually young age at which she died (aged 58), this puts her in a category shared by only a handful of known cases worldwide, Esiri says.
The discovery may also rekindle fears over drinking and cooking using aluminium pots and pans, although Perl says that most aluminium is found in an insoluble form and therefore not dangerous. The only way to ingest aluminium would be by cooking acidic foods such as rhubarb or tomato, which would react with the metal.
The news is worrying for Camelford's residents, says Exley, who carried out the chemical analysis to spot the aluminium in the autopsy samples. "There are still 20,000 people thinking about whether they're susceptible to this chronic disease," he says. "We can't do anything to help them."
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Apr 12, 2013
Study Finds Flu Shot Makes People Sicker
Vermont has declared a statewide epidemic of whooping cough that started in 2012 and has continued into the year 2013. To date there has been a total of 612 confirmed cases of pertussis of which 90% have been vaccinated against the bacteria with the Tdap vaccine. The New England Journal of Medicine released a study that parallels this outbreak showing that of the confirmed cases of whooping cough the majored of them, 80%, had received multiple Tdap vaccinations most receiving 5 or 6 doses. The mainstream media have decided the only way to prevent the spread of the bacteria is to have everyone get their vaccinations refusing to acknowledge the overwhelming connection between vaccinated patients and outbreak victims. These vaccines have managed to damage and weaken the immune systems of children and adults leading to epidemic levels of fully vaccinated people becoming sick and contagious.Read the rest
Via: Metronews
A strange vaccine-related phenomenon spotted at the start of the 2009 flu pandemic may well have been real, a new study suggests. Canadian researchers noticed in the early weeks of the pandemic that people who got a flu shot for the 2008-2009 winter seemed to be more likely to get infected with the pandemic virus than people who hadn’t received a flu shot. Five studies done in several provinces showed the same puzzling and unsettling results. But initially research outside of Canada did not, and the effect was dismissed as “the Canadian problem.”
News of the unexpected findings broke at a time when countries in North America and parts of Europe were getting ready to start vaccinating their populations against the pandemic virus. Some jurisdictions were also trying to figure out whether to offer the seasonal flu vaccine they had purchased — similar to the 2008-2009 shot — along with the pandemic vaccine, in case the seasonal flu viruses continued to circulate. Quebec opted not to offer the seasonal vaccine because of the concerns raised by the studies.Many people in the flu research and public health communities found the whole event unhelpful, and many rejected the findings. Some suggested if there was a problem, it might have been with the flu vaccine used in Canada, because the problem wasn’t seen elsewhere. But a new study suggests the findings may indeed have been real.
A group of Canadian researchers recreated the event in ferrets, the best animal model for predicting how influenza will act in humans. They worked with animals because it would have been unethical to subject people to the health risks the work entailed. The findings of the ferret study were presented Sunday at ICAAC, a major international infectious diseases conference taking place this year in San Francisco. (ICAAC stands for the Interscience Conference on Antimicrobial Agents and Chemotherapy.) Lead author Dr. Danuta Skowronski outlined the work at a webcast press conference. Skowronski, an influenza expert at the B.C. Centre for Disease Control in Vancouver, also led the first study that spotted the apparent interaction between 2008 flu shots and pandemic flu infection. She and her colleagues worked with 32 ferrets, giving half the 2008 seasonal flu shot and the remainder a placebo injection. The work was blinded, meaning the researchers didn’t know which ferrets received which shot. Later, all the ferrets were infected with the pandemic H1N1 virus. The ferrets in the vaccine group became significantly sicker than the other animals, though all recovered. “The findings that we show are consistent with the increased risk that we saw in the human studies,” Skowronski said. She said that in the time since the pandemic, researchers in other countries have reported a similar interaction.
The reason for the effect is unclear, and Skowronski urged other research groups to take up the question. She said it is important to get to the root of what happened, before the next pandemic. But in the meantime, Skowronski insisted the findings should not deter people from getting seasonal flu shots. “I do think it’s important to clarify that our findings are unique to the pandemic,” she insisted. “Pandemics are infrequent occurrences, but seasonal influenza recurs on an annual basis. It’s a substantial cause of morbidity and mortality,” — science’s term for illness and death — “and the seasonal vaccine substantially protects against that severe outcome due to seasonal influenza.”
Two theories exist about what might have been behind the effect, said Skowronski, who favours the first. That theory relates to the fact that the 2008 vaccine protected against an H1N1 virus that was related to — but not similar enough to — the pandemic virus to generate antibodies that would neutralize it. The thinking is that might actually have facilitated infection with the pandemic virus. Skowronski likened the mechanism to what happens with dengue viruses. People who have been infected with one subtype of dengue don’t develop immunity to the other three. In fact, they are more at risk of developing a life-threatening form of dengue if they are infected with one of the other strains.
Skowronski called the second theory the infection block hypothesis. Having a bout of the flu gives the infected person antibodies that may be able, for a time, to fend off other strains; flu shots only protect against the strains they contain. So under this theory, people who didn’t have flu in 2008 because they got a flu shot may have been less well armed against the pandemic virus. If the first theory is right, the strange effect seen in 2009 might only occur in a pandemic in which the new virus was related to a circulating human flu virus, Skowronski admitted. If that’s correct — and she stressed it’s only a theory — a virus with a hemagglutinin protein that humans haven’t been exposed to before might not trigger this type of phenomenon. (The hemagglutinin is the protein on the exterior of a flu virus that gives it the H number in its name.) “My own opinion, my own feeling would be that if you have a completely different hemagglutinin like H5 or H7 … you may not see that,” Skowronski said. “But who knows, frankly? The wise man knows he knows nothing when it comes to influenza, so you always have to be cautious in speculating.”
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Via: Metronews
A strange vaccine-related phenomenon spotted at the start of the 2009 flu pandemic may well have been real, a new study suggests. Canadian researchers noticed in the early weeks of the pandemic that people who got a flu shot for the 2008-2009 winter seemed to be more likely to get infected with the pandemic virus than people who hadn’t received a flu shot. Five studies done in several provinces showed the same puzzling and unsettling results. But initially research outside of Canada did not, and the effect was dismissed as “the Canadian problem.”
News of the unexpected findings broke at a time when countries in North America and parts of Europe were getting ready to start vaccinating their populations against the pandemic virus. Some jurisdictions were also trying to figure out whether to offer the seasonal flu vaccine they had purchased — similar to the 2008-2009 shot — along with the pandemic vaccine, in case the seasonal flu viruses continued to circulate. Quebec opted not to offer the seasonal vaccine because of the concerns raised by the studies.Many people in the flu research and public health communities found the whole event unhelpful, and many rejected the findings. Some suggested if there was a problem, it might have been with the flu vaccine used in Canada, because the problem wasn’t seen elsewhere. But a new study suggests the findings may indeed have been real.
A group of Canadian researchers recreated the event in ferrets, the best animal model for predicting how influenza will act in humans. They worked with animals because it would have been unethical to subject people to the health risks the work entailed. The findings of the ferret study were presented Sunday at ICAAC, a major international infectious diseases conference taking place this year in San Francisco. (ICAAC stands for the Interscience Conference on Antimicrobial Agents and Chemotherapy.) Lead author Dr. Danuta Skowronski outlined the work at a webcast press conference. Skowronski, an influenza expert at the B.C. Centre for Disease Control in Vancouver, also led the first study that spotted the apparent interaction between 2008 flu shots and pandemic flu infection. She and her colleagues worked with 32 ferrets, giving half the 2008 seasonal flu shot and the remainder a placebo injection. The work was blinded, meaning the researchers didn’t know which ferrets received which shot. Later, all the ferrets were infected with the pandemic H1N1 virus. The ferrets in the vaccine group became significantly sicker than the other animals, though all recovered. “The findings that we show are consistent with the increased risk that we saw in the human studies,” Skowronski said. She said that in the time since the pandemic, researchers in other countries have reported a similar interaction.
The reason for the effect is unclear, and Skowronski urged other research groups to take up the question. She said it is important to get to the root of what happened, before the next pandemic. But in the meantime, Skowronski insisted the findings should not deter people from getting seasonal flu shots. “I do think it’s important to clarify that our findings are unique to the pandemic,” she insisted. “Pandemics are infrequent occurrences, but seasonal influenza recurs on an annual basis. It’s a substantial cause of morbidity and mortality,” — science’s term for illness and death — “and the seasonal vaccine substantially protects against that severe outcome due to seasonal influenza.”
Two theories exist about what might have been behind the effect, said Skowronski, who favours the first. That theory relates to the fact that the 2008 vaccine protected against an H1N1 virus that was related to — but not similar enough to — the pandemic virus to generate antibodies that would neutralize it. The thinking is that might actually have facilitated infection with the pandemic virus. Skowronski likened the mechanism to what happens with dengue viruses. People who have been infected with one subtype of dengue don’t develop immunity to the other three. In fact, they are more at risk of developing a life-threatening form of dengue if they are infected with one of the other strains.
Skowronski called the second theory the infection block hypothesis. Having a bout of the flu gives the infected person antibodies that may be able, for a time, to fend off other strains; flu shots only protect against the strains they contain. So under this theory, people who didn’t have flu in 2008 because they got a flu shot may have been less well armed against the pandemic virus. If the first theory is right, the strange effect seen in 2009 might only occur in a pandemic in which the new virus was related to a circulating human flu virus, Skowronski admitted. If that’s correct — and she stressed it’s only a theory — a virus with a hemagglutinin protein that humans haven’t been exposed to before might not trigger this type of phenomenon. (The hemagglutinin is the protein on the exterior of a flu virus that gives it the H number in its name.) “My own opinion, my own feeling would be that if you have a completely different hemagglutinin like H5 or H7 … you may not see that,” Skowronski said. “But who knows, frankly? The wise man knows he knows nothing when it comes to influenza, so you always have to be cautious in speculating.”
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Apr 11, 2013
This Detergent In Almost Every Flu Vaccine Affects The Blood Brain Barrier And Can Cause Seizures
Existing in this man-made medication matrix filled with monopolizing eugenicists the path of obstacles placed in front of our freedoms is illuminated with yet another travesty being committed on generation-next. The propagators of pestilence with their childhood immunization program have been able to covertly subject the youth of America to a constant flow of formaldehyde, a known carcinogen, leading to an epidemic of childhood related cancers. With the pharmaceutical industry being the elitist’s cash register it not hard to imagine that they have turned our children into a commodity.Read the rest
Via: PreventDisease
Every single vaccine currently in existence, whether for adults or children, contains at least one or more toxic ingredients or excipients that are injected directly into the body. One of these ingredients called sodium deoxycholate is found in almost every flu vaccine. This chemical is a water soluble ionic detergent/bile salt which causes cell death.It has been shown to weaken the blood-brain-barrier (BBB) and subsequently activate seizures. It has also demonstrated synergistic toxicity with other medications.
Detergents and emulsifiers promote tumors and cause cells to leak or explode by weakening their walls, with no mechanism for regulating destructive activity. These chemicals are not completely purified out of the final vaccine product, so they enter the body at the time of injection. Detergents are used extensively in cell research precisely because of their ability to break cells open for further analysis. This catastrophically mimics the membrane attack complex (MAC). Detergents hit cells at random and continue destroying cells regardless of which call off the attack.
Sodium Deoxycholate is completely foreign to the relationships that define and make up the delicate balance of the immune system. It systematically disrupts these relationships to negate the optimal function and design of immune responses. According to Thermo Scientific, it is especially useful for disrupting and dissociating protein interactions. Vanderbilt University School of Medicine researchers showed that the pharmacokinetics and toxicity of sodium deoxycholate produced an inflammatory response that persisted 10 days.
Deoxcyholate also induces DNA damage and apoptosis in human colon. Because secondary bile acids are thought to be genotoxic, exposing colon epithelial cells to secondary bile acids may induce DNA damage that might lead to apoptosis.
The pharmacokinetics of vaccines are never examined meaning that no study has ever established the rates of bodily absorption, distribution, metabolism and excretion of any of the ingredients including any of the toxic extraneous components such as sodium deoxycholate. This can easily be verified by reading the vaccine insert or manufacturer's PDF of the formulation on their website. It's certainly not a chemical that will advance the status of human health regardless of the claims behind the medical industry or touting of the benefits exceeding the risks. Since the benefits of the flu vaccine are typically less than 4% and maximum 6.25%, I would say the risks from have sodium deoxycholate injected directly into your body far exceed any benefit that may be derived from ANY flu vaccine.
Please ask this of any person who still believes in the flu vaccine: Would you rather risk injecting a chemical solution containing foreign DNA and a detergent like sodium deoxycholate (or thimerosal) with all of the potentially toxic effects and a maximum protection of 6.25% against the flu, or would you rather just take your chances?
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Apr 10, 2013
Officials urge flu shots as outbreak hits: Nasal Sprays Makes Kids Carriers
United Kingdom is set to be the first country to offer the seasonal flu vaccination to all children enrolled in the public educational system. The nasal flu vaccine being offered to over 9 million children is sold under the brand name Fluenz in Europe and FluMist in the United States, is made by AstraZeneca’s MedImmune unit and has been available for the past decade in the U.S. This is the largest contract the company has received outside of the U.S. taking its first steps into the global dissemination of inhalable poisons. The FluMist vaccine contains a live virus and is squirted up the nose where the virus can live and breed for up to 28 days while it damages your immune system. Could the sneeze be the new WMD Weaponized Mucus Device a way to infect and spread diseases through the populations? Having been cooked up in a label run by the new world order’s pharmaceutical psychopaths you can only assume there is a hidden agenda and as always it includes reducing the global population.Read the rest
Via: TheNewsTribune
Four-year-old Sarahi Larios cried in her mom’s lap when she received the flu vaccine Wednesday night in Tacoma. The nasal spray for children startled the young girl. Alma Alvarado brought Sarahi and her other daughter, Alejandra Larios, 17, to the Tacoma-Pierce County Health Department for free flu vaccines to protect all of them during a severe flu season. “I’m very worried,” said Alvarado, 34, of Tacoma. “I heard about it on the news.”
They were among 142 people vaccinated Wednesday at the second and last free flu vaccine clinic for children and uninsured adults this season put on by the Health Department. Waiting for her shot in the arm, Denise Durham said she worries about contracting the flu or something worse. “This is so bad,” said Durham, 54, of Tacoma. “It’s killing people.”
This year’s flu season is the worst since the pandemic in 2009 of the so-called swine flu, said public health nurse Denise Stinson. This outbreak hit early and is more severe than usual, said Stinson, the department’s influenza surveillance coordinator. “We think it’s still valuable to get your flu vaccine,” she said. “Influenza will continue to circulate for probably several more weeks.”
The flu outbreak, plus a variety of other infectious diseases, have filled Pierce County hospitals to capacity, officials say. Two flu-related deaths have been reported during this flu season in Pierce County. One involved a boy younger than 12; the other was a woman in her 70s, Stinson said. This year’s flu strain is particularly causing more serious illness in people older than 65, she said.
The clinics provide a safety net for those without insurance, Stinson said. Without insurance, a flu shot costs from $25 to $35 from local providers. About 200 people turned out Jan. 16 for the department’s first clinic. Pierce County Medical Reserve Corps volunteers administered the vaccines at both clinics. The Health Department, at 3629 S. D St., also has coordinated the distribution of 63,000 doses of flu vaccine through the state’s Vaccine for Children Program. As of early this month, about 43,000 of those doses had been administered.
Through a partnership with vaccine maker Sanofi Pasteur, the Health Department is making free vaccines available through local pharmacies for low-income adults. The flu is a respiratory illness with symptoms including a fever above 100 degrees, a cough, body aches and a sore throat. Phai Phan, 23, was first in line with her mother and brother to get vaccinated at the 90-minute clinic. Phan said she and her mother, Thanh-Qui Nguyen, 49, both became sick with the flu last year, even though they were vaccinated. “Every winter when the weather changes, I get sick very easily,” said Phan, of Tacoma. “It’s better to get some protection.”
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Apr 9, 2013
Narcolepsy 'link to swine flu jab' BBC News
The New World Orders “big pharma division” has gone to great lengths to ensure that you get the medications and vaccinations you deserve. Only this time they have been exposed in their idea of what ensure and deserve really mean. The Pandemrix H1N1 vaccination given to Europeans living in Sweden & Finland has been linked to multiple narcolepsy cases occurring in children and adolescents ever since the man made 2009 swine flu pandemic was declared and the false solutions were presented. GlaxoSmithKline is the manufacture of the bunk flu vaccine that is now a banned substance in both the United States and Europe having failed on numerous attempts to cover up their actions they have plead guilty to fraud. Read the rest
Via: BBC News
An increased risk of narcolepsy has been found among English children vaccinated with the swine flu vaccine, Pandemrix.
A Health Protection Agency study found a 10-fold increased risk in cases of the sleep disorder in children seen in sleep centres who had received the jab.
Manufacturer GlaxoSmithKline (GSK) has been ordered to investigate the link.
Families who believe they were affected are now considering a group legal action.
Pandemrix was most widely used in the UK during the 2009-10 flu pandemic and given to almost a million British children between six months and five years old. The vaccine, which is no longer used, has already been linked to narcolepsy in youngsters from Finland, Sweden and Ireland.
Narcolepsy is a rare sleeping condition. The main symptom is falling asleep suddenly and it may also cause muscle weakness.
The HPA abstract paper, from Developmental Medicine in Childhood Neurology, was presented to a conference of paediatricians in Manchester and is now being considered for publication in full by the British Medical Journal. It estimates the risk was one in 52,000 in those vaccinated.
Specialists reviewed 75 children aged four to 18 who developed narcolepsy about the time Pandemrix was rolled out. Of these, 18 had received Pandemrix.
They found a 10-fold increased risk of the condition within six months of having the jab which "suggests a causal association consistent with reports from Finland and Sweden".
An expert in vaccines who was in charge of one of the paediatric clinical trials of Pandemrix, Prof Adam Finn from the University of Bristol, said: "The risk is so much increased that it seems very unlikely that this is a biased result.
"The bottom line is they have found they were somewhere between 10 and 16 times more likely to have had Pandemrix than other children. So that confirms what you would expect to see based on other studies done in Finland, Sweden and Ireland, which are all the same."
Research programme
The European Medicines Agency (EMA) warned in 2011 that Pandemrix should only be given to children and teenagers at risk of H1N1 flu if other jabs are unavailable because of concerns of potential link to narcolepsy.
It has ordered GSK to commit to a complex research programme to look at the root causes.
GSK say they take the safety of patients very seriously and are working hard to better understand the research emerging from a select number of countries.
A spokesperson said: "Narcolepsy is a complex disease and its causes are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections.
"It is crucial that we learn more about how narcolepsy is triggered and how Pandemrix might have interacted with other risk factors in affected individuals. Throughout development there was no data suggesting a potential for an increased risk of narcolepsy among those vaccinated."
It is understood that one possible trigger is the high levels of adjuvant in the vaccine used to enhance the recipients response.
The UK government, which gave GSK a legal indemnity against having to pay compensation, could now face the prospect of a group legal action by families affected.
The Department of Work and Pensions, which is responsible for administering Vaccine Damage Payments Scheme says there is currently insufficient medical evidence to show that the swine flu vaccine causes narcolepsy.
A spokesperson for the Medicines and Healthcare products Regulatory Agency said: "The results of the HPA study are consistent with earlier evidence from some other EU countries and support the regulatory action already taken in Europe to restrict the use of Pandemrix in those aged under 20 years."
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Via: BBC News
An increased risk of narcolepsy has been found among English children vaccinated with the swine flu vaccine, Pandemrix.
A Health Protection Agency study found a 10-fold increased risk in cases of the sleep disorder in children seen in sleep centres who had received the jab.
Manufacturer GlaxoSmithKline (GSK) has been ordered to investigate the link.
Families who believe they were affected are now considering a group legal action.
Pandemrix was most widely used in the UK during the 2009-10 flu pandemic and given to almost a million British children between six months and five years old. The vaccine, which is no longer used, has already been linked to narcolepsy in youngsters from Finland, Sweden and Ireland.
Narcolepsy is a rare sleeping condition. The main symptom is falling asleep suddenly and it may also cause muscle weakness.
The HPA abstract paper, from Developmental Medicine in Childhood Neurology, was presented to a conference of paediatricians in Manchester and is now being considered for publication in full by the British Medical Journal. It estimates the risk was one in 52,000 in those vaccinated.
Specialists reviewed 75 children aged four to 18 who developed narcolepsy about the time Pandemrix was rolled out. Of these, 18 had received Pandemrix.
They found a 10-fold increased risk of the condition within six months of having the jab which "suggests a causal association consistent with reports from Finland and Sweden".
An expert in vaccines who was in charge of one of the paediatric clinical trials of Pandemrix, Prof Adam Finn from the University of Bristol, said: "The risk is so much increased that it seems very unlikely that this is a biased result.
"The bottom line is they have found they were somewhere between 10 and 16 times more likely to have had Pandemrix than other children. So that confirms what you would expect to see based on other studies done in Finland, Sweden and Ireland, which are all the same."
Research programme
The European Medicines Agency (EMA) warned in 2011 that Pandemrix should only be given to children and teenagers at risk of H1N1 flu if other jabs are unavailable because of concerns of potential link to narcolepsy.
It has ordered GSK to commit to a complex research programme to look at the root causes.
GSK say they take the safety of patients very seriously and are working hard to better understand the research emerging from a select number of countries.
A spokesperson said: "Narcolepsy is a complex disease and its causes are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections.
"It is crucial that we learn more about how narcolepsy is triggered and how Pandemrix might have interacted with other risk factors in affected individuals. Throughout development there was no data suggesting a potential for an increased risk of narcolepsy among those vaccinated."
It is understood that one possible trigger is the high levels of adjuvant in the vaccine used to enhance the recipients response.
The UK government, which gave GSK a legal indemnity against having to pay compensation, could now face the prospect of a group legal action by families affected.
The Department of Work and Pensions, which is responsible for administering Vaccine Damage Payments Scheme says there is currently insufficient medical evidence to show that the swine flu vaccine causes narcolepsy.
A spokesperson for the Medicines and Healthcare products Regulatory Agency said: "The results of the HPA study are consistent with earlier evidence from some other EU countries and support the regulatory action already taken in Europe to restrict the use of Pandemrix in those aged under 20 years."
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Apr 8, 2013
FDA approves first flu vaccine grown in insect cells
The New World orders eugenicist program has gone into overdrive with the FDA’s approval of a new vaccine technology that uses insect cells to produce the ingredients needed for their toxic inoculations. Instead of using chicken eggs to grow the necessary viral components used in the vaccinators’ lancet the pharmacratic dictatorship have pumped massive amounts of taxpayer dollars into this exotic technology to ensure eugenicists reach their goal of population elimination on a global scale.Read the Rest
The article below was discovered down the pharmacuetical rabbit hole make sure to be wearing your They Live glasses....enjoy your trip!
Via: CIDRAP
The US Food and Drug Administration (FDA) has approved the first influenza vaccine produced with the help of an insect virus and recombinant DNA technology, an approach the agency says may make it possible to start production faster in the event of a flu pandemic.
Flublok, a trivalent (three-strain) vaccine developed by Protein Sciences Corp. of Meriden, Conn., was approved for adults ages 18 through 49. The only flu virus component it contains is hemagglutinin, the active ingredient, which is produced by infecting cultures of insect cells with a baculovirus that turns them into hemagglutinin factories.
Most flu vaccines use viruses grown in chicken eggs. However, in November the FDA approved Novartis's Flucelvax, which uses flu viruses grown in mammalian cells, making it the first vaccine of its kind to gain US approval.
Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, called Flublok a technological advance. "The new technology offers the potential for faster startup of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus," she said in an FDA press release.
But the vaccine is similar to other licensed flu vaccines in that it uses hemagglutinin as the active ingredient or immune system target, according to a recent major report on flu vaccines. A number of flu experts have said that new kinds of flu vaccines with novel antigens are needed in order to provide broader, more enduring protection than today's vaccines, which must be reformulated each year to keep pace with viral mutations. Today's vaccines are generally about 60% effective in working-age adults.
In a press release, Protein Sciences called Flublok the first flu vaccine "to be made in a 100% egg-free system without growing influenza viruses—so the vaccine can be made quickly and without any of the infectious risk traditionally associated with vaccine manufacture." The vaccine contains no thimerosal (a preservative used in some vaccines), antibiotics, or adjuvants, the company said.
The product contains 45 micrograms (mcg) of hemagglutinin for each of the three targeted flu strains, which is three times what most other flu vaccines contain.
Manon Cox, PhD, MBA, the company's chief executive officer, told CIDRAP News that early studies of the vaccine showed that higher-than-standard doses induced better immune responses. The company eventually settled on 45 mcg as the optimal dose.
The FDA said Flublok was found to be about 44.6% effective against all flu strains in a controlled trial conducted at multiple US sites. The vaccine was given to about 2,300 people, while a similar number of volunteers received a placebo.
The vaccine's safety was tested in about 2,500 volunteers, the FDA said. The most common side effects were pain at the injection site, headache, fatigue, and muscle aches, which are also common in recipients of conventional egg-based flu vaccines.
Protein Sciences said Flublok will be widely available for the 2013-14 flu season. The company also hopes to provide a limited supply this season, but no doses are available yet, said Cox.
She said a problem with the fill-finish stage of production is holding up the vaccine right now. The product "is sitting in a big refrigerator in McPherson, Kansas, and we're waiting for the vials to be packaged and shipped to us," she told CIDRAP News, noting that the fill-finish step is handled by a subcontractor.
Cox said the company is considering a price of about $30 per dose for the vaccine, but no decision has been made yet. "We're very sensitive to the fact that most people feel vaccine should be provided for free," she commented.
Hemagglutinin for Flublok is produced by infecting insect cells with a baculovirus that has been altered to contain the gene for hemagglutinin. Baculoviruses infect a few insect species and are commonly found on green vegetables but do not grown in mammalian cells, according to previous reports.
Most conventional flu vaccines consist of whole, killed flu viruses or viral fragments that contain several proteins, not just hemagglutinin (though one vaccine uses a live, weakened virus).
Cox said it took a very long time to develop Flublok and gain FDA approval, in large part because the agency had many questions about the safety of the new production technology.
"It took 20 years to go from proof of concept to convincing the agency that this would work," she said.
Although the vaccine is highly purified, it contains some residual proteins of nonhuman origin, Cox noted. "All the evidence was that it was safe," she said. "There were no signs that our new cell line wasn't good enough. It's always very hard to prove a negative."
Early development of the vaccine was supported by the National Institute for Allergy and Infectious Diseases. In 2009, the company won a contract from the US Biomedical Advanced Research and Development Agency, part of the Department of Health and Human Services, for late-stage development.
Cox said the company is preparing to launch a trial of the vaccine in people 50 and older, with the hope of winning FDA approval for that age-group late this year. The agency had concerns about hypersensitivity reactions seen in some over-50 participants in a previous trial, although such reactions were twice as common in a comparison group that received a conventional flu vaccine, she explained.
Protein Sciences also plans to run a trial of Flublok in children ages 6 to 18 in the 2013-14 flu season, with the hope of winning FDA approval for that age-group the year after that, Cox said. Earlier, the vaccine was tested in very young children who had never had flu before, and it was found to be not very immunogenic, she noted.
As for the promise of faster production startups with Flublok, Cox said, "In 21 days after we have the genetic sequence [of the target virus], we are able to get it into production, so that's a substantially shorter time to do it than in cell culture or in eggs." But she noted that later steps, such as filling and finishing vaccine vials, can cause delays.
Nicholas Kelley, PhD, a coauthor of a lengthy analysis of flu vaccines published last year, agreed that the new vaccine promises to allow faster production startups.
"It can be produced and scaled up on a larger scale and faster than a mammalian cell culture vaccine," he said. But he added that in comparison with other flu vaccines, "there's no difference in how well it works."
Kelley is a research associate at the University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News. He helped write The Compelling Need for Game-Changing Influenza Vaccines, a lengthy report on the whole flu vaccine landscape, published last October.
The report notes that alternative flu vaccine production platforms such as mammalian cell culture and insect cell culture improve on conventional egg-based technology in that they are likely to shorten the production time and are less prone to contamination. It cites Flublok as an insect-cell–based vaccine.
"However, as long as such vaccines continue to be directed toward the HA [hemagglutinin]-head antigen, they will have little potential to improve vaccine effectiveness or to provide broad, durable protection against disease," the report states.
The FDA noted that the shelf life for Flublok is 16 weeks from the data of manufacture. That compares with about 1 year for most flu vaccines.
Cox said the 16-week shelf life "has to do with our worst-case production lots in 2007,'" adding, "Since then we got data indicating it's feasible to get a shelf life of 9 to 12 months, but we didn't want to give new information to the agency [FDA] at this moment" for fear of causing further delays. She said the company hopes to get the listed shelf life changed soon.
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The article below was discovered down the pharmacuetical rabbit hole make sure to be wearing your They Live glasses....enjoy your trip!
Via: CIDRAP
The US Food and Drug Administration (FDA) has approved the first influenza vaccine produced with the help of an insect virus and recombinant DNA technology, an approach the agency says may make it possible to start production faster in the event of a flu pandemic.
Flublok, a trivalent (three-strain) vaccine developed by Protein Sciences Corp. of Meriden, Conn., was approved for adults ages 18 through 49. The only flu virus component it contains is hemagglutinin, the active ingredient, which is produced by infecting cultures of insect cells with a baculovirus that turns them into hemagglutinin factories.
Most flu vaccines use viruses grown in chicken eggs. However, in November the FDA approved Novartis's Flucelvax, which uses flu viruses grown in mammalian cells, making it the first vaccine of its kind to gain US approval.
Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, called Flublok a technological advance. "The new technology offers the potential for faster startup of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus," she said in an FDA press release.
But the vaccine is similar to other licensed flu vaccines in that it uses hemagglutinin as the active ingredient or immune system target, according to a recent major report on flu vaccines. A number of flu experts have said that new kinds of flu vaccines with novel antigens are needed in order to provide broader, more enduring protection than today's vaccines, which must be reformulated each year to keep pace with viral mutations. Today's vaccines are generally about 60% effective in working-age adults.
In a press release, Protein Sciences called Flublok the first flu vaccine "to be made in a 100% egg-free system without growing influenza viruses—so the vaccine can be made quickly and without any of the infectious risk traditionally associated with vaccine manufacture." The vaccine contains no thimerosal (a preservative used in some vaccines), antibiotics, or adjuvants, the company said.
The product contains 45 micrograms (mcg) of hemagglutinin for each of the three targeted flu strains, which is three times what most other flu vaccines contain.
Manon Cox, PhD, MBA, the company's chief executive officer, told CIDRAP News that early studies of the vaccine showed that higher-than-standard doses induced better immune responses. The company eventually settled on 45 mcg as the optimal dose.
The FDA said Flublok was found to be about 44.6% effective against all flu strains in a controlled trial conducted at multiple US sites. The vaccine was given to about 2,300 people, while a similar number of volunteers received a placebo.
The vaccine's safety was tested in about 2,500 volunteers, the FDA said. The most common side effects were pain at the injection site, headache, fatigue, and muscle aches, which are also common in recipients of conventional egg-based flu vaccines.
Protein Sciences said Flublok will be widely available for the 2013-14 flu season. The company also hopes to provide a limited supply this season, but no doses are available yet, said Cox.
She said a problem with the fill-finish stage of production is holding up the vaccine right now. The product "is sitting in a big refrigerator in McPherson, Kansas, and we're waiting for the vials to be packaged and shipped to us," she told CIDRAP News, noting that the fill-finish step is handled by a subcontractor.
Cox said the company is considering a price of about $30 per dose for the vaccine, but no decision has been made yet. "We're very sensitive to the fact that most people feel vaccine should be provided for free," she commented.
Hemagglutinin for Flublok is produced by infecting insect cells with a baculovirus that has been altered to contain the gene for hemagglutinin. Baculoviruses infect a few insect species and are commonly found on green vegetables but do not grown in mammalian cells, according to previous reports.
Most conventional flu vaccines consist of whole, killed flu viruses or viral fragments that contain several proteins, not just hemagglutinin (though one vaccine uses a live, weakened virus).
Cox said it took a very long time to develop Flublok and gain FDA approval, in large part because the agency had many questions about the safety of the new production technology.
"It took 20 years to go from proof of concept to convincing the agency that this would work," she said.
Although the vaccine is highly purified, it contains some residual proteins of nonhuman origin, Cox noted. "All the evidence was that it was safe," she said. "There were no signs that our new cell line wasn't good enough. It's always very hard to prove a negative."
Early development of the vaccine was supported by the National Institute for Allergy and Infectious Diseases. In 2009, the company won a contract from the US Biomedical Advanced Research and Development Agency, part of the Department of Health and Human Services, for late-stage development.
Cox said the company is preparing to launch a trial of the vaccine in people 50 and older, with the hope of winning FDA approval for that age-group late this year. The agency had concerns about hypersensitivity reactions seen in some over-50 participants in a previous trial, although such reactions were twice as common in a comparison group that received a conventional flu vaccine, she explained.
Protein Sciences also plans to run a trial of Flublok in children ages 6 to 18 in the 2013-14 flu season, with the hope of winning FDA approval for that age-group the year after that, Cox said. Earlier, the vaccine was tested in very young children who had never had flu before, and it was found to be not very immunogenic, she noted.
As for the promise of faster production startups with Flublok, Cox said, "In 21 days after we have the genetic sequence [of the target virus], we are able to get it into production, so that's a substantially shorter time to do it than in cell culture or in eggs." But she noted that later steps, such as filling and finishing vaccine vials, can cause delays.
Nicholas Kelley, PhD, a coauthor of a lengthy analysis of flu vaccines published last year, agreed that the new vaccine promises to allow faster production startups.
"It can be produced and scaled up on a larger scale and faster than a mammalian cell culture vaccine," he said. But he added that in comparison with other flu vaccines, "there's no difference in how well it works."
Kelley is a research associate at the University of Minnesota's Center for Infectious Disease Research and Policy, which publishes CIDRAP News. He helped write The Compelling Need for Game-Changing Influenza Vaccines, a lengthy report on the whole flu vaccine landscape, published last October.
The report notes that alternative flu vaccine production platforms such as mammalian cell culture and insect cell culture improve on conventional egg-based technology in that they are likely to shorten the production time and are less prone to contamination. It cites Flublok as an insect-cell–based vaccine.
"However, as long as such vaccines continue to be directed toward the HA [hemagglutinin]-head antigen, they will have little potential to improve vaccine effectiveness or to provide broad, durable protection against disease," the report states.
The FDA noted that the shelf life for Flublok is 16 weeks from the data of manufacture. That compares with about 1 year for most flu vaccines.
Cox said the 16-week shelf life "has to do with our worst-case production lots in 2007,'" adding, "Since then we got data indicating it's feasible to get a shelf life of 9 to 12 months, but we didn't want to give new information to the agency [FDA] at this moment" for fear of causing further delays. She said the company hopes to get the listed shelf life changed soon.
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Apr 5, 2013
GeoVax is On Track to Advance its HIV/AIDS Vaccine Programs in 2013 - Analyst Blog
HIV Vaccine Infects 172 Patients During Clinical Trials
Via: Nasdaq
Full Year 2012 Financial Results
GeoVax reported revenues of $2.7 million for 2012, related to grants from the NIH. This compares to $4.9 million of grant revenue reported in 2011. As of December 31, 2012, there was approximately $3.0 million in unused grant funds available for use through August 31, 2013 (the end of the grant project periods).
Research and development (R&D) expenses were $3.0 million in 2012, compared with $4.3 million in 2011. R&D expenses include $1.8 million and $3.0 million for 2012 and 2011, respectively, in direct costs funded by NIH grants; and also include vaccine manufacturing costs and costs related to the Phase I/II clinical trial of the Company's therapeutic vaccine, being sponsored by GeoVax. Costs associated with the conduct of a Phase IIa clinical trial of GeoVax's preventative vaccine (completed during 2012) and a Phase I clinical trial of GeoVax's second-generation vaccine (both trials conducted by the HVTN) are being funded directly by the NIH and are therefore not reflected in GeoVax's financial statements.
General and administrative (G&A) expenses were $1.8 million and $3.0 million in 2012 and 2011, respectively. G&A expenses were lower during 2012 primarily due to lower legal costs, patent costs and stock-based compensation expense related to investment advisory fees and investor warrant extensions.
The Company reported a net loss for the year ended December 31, 2012 of $2.1 million, or $0.12 per share, based on 18.3 million weighted average shares outstanding. For the year ended December 31, 2011, the Company reported a loss of $2.3 million, or $0.15 per share, based on 15.7 million weighted average shares outstanding.
Cash balances as of December 31, 2012 was $1.0 million, as compared to $1.2 million at December 31, 2011.
We think the earnings report is a non-event for GeoVax. Investors should be focused on the Company's progress in its clinical programs. In this regard, we think GeoVax has made great progress for its HIV/AIDS programs and is on track to further advance these clinical programs in 2013.
Progress on Clinical Development
Preventive Vaccine - Phase IIa Trial. The Phase IIa trial (HVTN 205) of GeoVax's preventive HIV/AIDS vaccine has been completed. Results of this trial were presented in September 2012 by the HIV Vaccine Trials Network (HVTN) at the AIDS Vaccine 2012 Conference in Boston. HVTN 205 confirmed the Phase I results, with the GeoVax vaccine demonstrating an excellent safety profile and reproducible T cell and antibody immune responses. The Company expects formal publication of the full study results by the end of 2013.
Preventive Vaccine (2nd-generation) - Phase I Trial. Patient enrollment was completed in December 2012 for the Phase I trial testing the safety of GeoVax's second-generation vaccine (GM-CSF adjuvanted). GeoVax expects the Phase I trial to be completed in the second half of 2013.
Preventive Vaccine (2nd-generation) - Phase II Efficacy Trial Planning. Pending successful outcome of Phase I testing of the second-generation vaccine, GeoVax expects to advance this version of its preventive vaccine into Phase II efficacy testing in high-risk individuals, expected to begin in 2014. The Company is currently in discussions with the HVTN regarding protocol development and anticipates knowing more about the trial design and the government funding consortium in late 2013.
Therapeutic Vaccine - Treatment Interruption Study. The Company's ongoing Phase I/II "treatment interruption" clinical trial, investigating the use of its vaccine for treatment of individuals already infected with HIV, completed enrollment at the end of 2012. GeoVax expects to see data readouts from this study during 2013, which might indicate the potential use of its vaccines to treat HIV infection, either as a standalone therapy or in conjunction with an oral drug regimen.
New Clinical Trial Planned for Combination Therapy
GeoVax is collaborating with the NIH and planning is underway for a second therapeutic clinical trial to begin in mid-2013. This Phase I trial will investigate the use of GeoVax's therapeutic vaccine in combination with standard-of-care drug therapy in HIV-positive young adults. The Company expects this trial to be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT), a program supported by the NIH. Because of the mechanisms by which current oral drugs work, if the virus is in latent phase (non-replicating), the drugs are not effective, thus it is impossible to totally eradicate the virus. There is hope for a combination approach using the patient's own immune system stimulated by the vaccine, together with oral drugs to eradicate the virus -- thereby potentially offering a cure.
We think GeoVax has made great progress in its HIV/AIDS vaccine clinical programs. We are especially pleased to see that the Company is planning a new clinical trial combining its HIV/AIDS therapeutic vaccine with AIDS drugs in mid-2013. This will provide a new big market for the Company's vaccine.
Contact Information
Via: Nasdaq
Full Year 2012 Financial Results
GeoVax reported revenues of $2.7 million for 2012, related to grants from the NIH. This compares to $4.9 million of grant revenue reported in 2011. As of December 31, 2012, there was approximately $3.0 million in unused grant funds available for use through August 31, 2013 (the end of the grant project periods).
Research and development (R&D) expenses were $3.0 million in 2012, compared with $4.3 million in 2011. R&D expenses include $1.8 million and $3.0 million for 2012 and 2011, respectively, in direct costs funded by NIH grants; and also include vaccine manufacturing costs and costs related to the Phase I/II clinical trial of the Company's therapeutic vaccine, being sponsored by GeoVax. Costs associated with the conduct of a Phase IIa clinical trial of GeoVax's preventative vaccine (completed during 2012) and a Phase I clinical trial of GeoVax's second-generation vaccine (both trials conducted by the HVTN) are being funded directly by the NIH and are therefore not reflected in GeoVax's financial statements.
General and administrative (G&A) expenses were $1.8 million and $3.0 million in 2012 and 2011, respectively. G&A expenses were lower during 2012 primarily due to lower legal costs, patent costs and stock-based compensation expense related to investment advisory fees and investor warrant extensions.
The Company reported a net loss for the year ended December 31, 2012 of $2.1 million, or $0.12 per share, based on 18.3 million weighted average shares outstanding. For the year ended December 31, 2011, the Company reported a loss of $2.3 million, or $0.15 per share, based on 15.7 million weighted average shares outstanding.
Cash balances as of December 31, 2012 was $1.0 million, as compared to $1.2 million at December 31, 2011.
We think the earnings report is a non-event for GeoVax. Investors should be focused on the Company's progress in its clinical programs. In this regard, we think GeoVax has made great progress for its HIV/AIDS programs and is on track to further advance these clinical programs in 2013.
Progress on Clinical Development
Preventive Vaccine - Phase IIa Trial. The Phase IIa trial (HVTN 205) of GeoVax's preventive HIV/AIDS vaccine has been completed. Results of this trial were presented in September 2012 by the HIV Vaccine Trials Network (HVTN) at the AIDS Vaccine 2012 Conference in Boston. HVTN 205 confirmed the Phase I results, with the GeoVax vaccine demonstrating an excellent safety profile and reproducible T cell and antibody immune responses. The Company expects formal publication of the full study results by the end of 2013.
Preventive Vaccine (2nd-generation) - Phase I Trial. Patient enrollment was completed in December 2012 for the Phase I trial testing the safety of GeoVax's second-generation vaccine (GM-CSF adjuvanted). GeoVax expects the Phase I trial to be completed in the second half of 2013.
Preventive Vaccine (2nd-generation) - Phase II Efficacy Trial Planning. Pending successful outcome of Phase I testing of the second-generation vaccine, GeoVax expects to advance this version of its preventive vaccine into Phase II efficacy testing in high-risk individuals, expected to begin in 2014. The Company is currently in discussions with the HVTN regarding protocol development and anticipates knowing more about the trial design and the government funding consortium in late 2013.
Therapeutic Vaccine - Treatment Interruption Study. The Company's ongoing Phase I/II "treatment interruption" clinical trial, investigating the use of its vaccine for treatment of individuals already infected with HIV, completed enrollment at the end of 2012. GeoVax expects to see data readouts from this study during 2013, which might indicate the potential use of its vaccines to treat HIV infection, either as a standalone therapy or in conjunction with an oral drug regimen.
New Clinical Trial Planned for Combination Therapy
GeoVax is collaborating with the NIH and planning is underway for a second therapeutic clinical trial to begin in mid-2013. This Phase I trial will investigate the use of GeoVax's therapeutic vaccine in combination with standard-of-care drug therapy in HIV-positive young adults. The Company expects this trial to be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT), a program supported by the NIH. Because of the mechanisms by which current oral drugs work, if the virus is in latent phase (non-replicating), the drugs are not effective, thus it is impossible to totally eradicate the virus. There is hope for a combination approach using the patient's own immune system stimulated by the vaccine, together with oral drugs to eradicate the virus -- thereby potentially offering a cure.
We think GeoVax has made great progress in its HIV/AIDS vaccine clinical programs. We are especially pleased to see that the Company is planning a new clinical trial combining its HIV/AIDS therapeutic vaccine with AIDS drugs in mid-2013. This will provide a new big market for the Company's vaccine.
Contact Information
Apr 4, 2013
Boost Oregon's childhood vaccination rates by trying Washington's technique | OregonLive.com
Via: Oregonlive
Oregon could wait for an epidemic. The state could retain its casual approach to childhood vaccinations and keep its ranking as the nation's worst for protecting children against terrible and preventable diseases.
Or, Oregon could follow Washington's lead and take one simple step to improve its childhood vaccination rates -- and do so without infringing on anyone's religious liberty.
The choice is clear. Oregon should pass a Senate bill under consideration that would require parents who withhold mandatory vaccines from their children to get a doctor's signature showing that they have been informed of the risks and benefits. As Washington has proven, this requirement is surprisingly effective at boosting a state's childhood vaccination rate virtually overnight.
Today in Oregon, children entering kindergarten need to show proof of immunization against numerous serious diseases, including polio, whooping cough and measles. Vaccines help protect the individual child, build "herd immunity" for the community and reduce the risk for those who are too young or sick to be safely vaccinated.
Oregon does offer two exceptions to its vaccination rule: Parents can get a medical exemption by bringing a letter from a doctor explaining the child's medical condition, or they can get a religious exemption by merely checking a box. Since Oregon defines religion as any belief system, parents use this option quite liberally. About 5.8 percent of Oregon kindergartners skip vaccines for nonmedical reasons, which is the nation's highest rate.
Contact Information
Oregon could wait for an epidemic. The state could retain its casual approach to childhood vaccinations and keep its ranking as the nation's worst for protecting children against terrible and preventable diseases.
Or, Oregon could follow Washington's lead and take one simple step to improve its childhood vaccination rates -- and do so without infringing on anyone's religious liberty.
The choice is clear. Oregon should pass a Senate bill under consideration that would require parents who withhold mandatory vaccines from their children to get a doctor's signature showing that they have been informed of the risks and benefits. As Washington has proven, this requirement is surprisingly effective at boosting a state's childhood vaccination rate virtually overnight.
Today in Oregon, children entering kindergarten need to show proof of immunization against numerous serious diseases, including polio, whooping cough and measles. Vaccines help protect the individual child, build "herd immunity" for the community and reduce the risk for those who are too young or sick to be safely vaccinated.
Oregon does offer two exceptions to its vaccination rule: Parents can get a medical exemption by bringing a letter from a doctor explaining the child's medical condition, or they can get a religious exemption by merely checking a box. Since Oregon defines religion as any belief system, parents use this option quite liberally. About 5.8 percent of Oregon kindergartners skip vaccines for nonmedical reasons, which is the nation's highest rate.
Contact Information
Apr 3, 2013
Hep B Vaccine Damages The Liver It Is Supposed To Protect
Hepatitis B Vaccination Causing Liver Damage
Research and Links
Via: Greenmedinfo
Startling new research published in the journal Apoptosis indicates that hepatitis B vaccine, which is designed to prevent Hepatitis B virus-induced damage to the liver, actually causes liver cell destruction.
In the study titled "Hepatitis B vaccine induces apoptotic death in Hepa1-6 cells," researchers set out to "...establish an in vitro model system amenable to mechanistic investigations of cytotoxicity induced by hepatitis B vaccine, and to investigate the mechanisms of vaccine-induced cell death."1
They found the hepatitis B vaccine induced a "loss of mitochondrial integrity, apoptosis induction, and cell death" in liver cells exposed to a low dose of adjuvanted hepatitis B vaccine. The adjuvant used was aluminum hydroxide, which is increasingly being identified as a contributing cause of autoimmune disease in immunized populations.
The discovery that the hepatitis B vaccine damages the liver (hepatotoxicity) confirms earlier findings (1999) that the vaccine increases the incidence of liver problems in U.S. children less than 6 years old by up to 294% versus unvaccinated controls.
Another study published in the journal Hepatogastroentology in 2002, observed that Hepatitis B vaccination was statistically associated with gastrointestinal reactions including: hepatitis, gastrointestinal disease and liver function test abnormalities in comparison to other vaccine control groups.
This, however, is only the tip of the iceberg...
In a revealing study published in June 2011 in the journal Molecular Biology Reports, researchers demonstrated that hepatitis B vaccine alters the expression of 144 genes in the mouse liver within 1 day of vaccination, 7 of which are related to inflammation and metabolism. The authors noted:
"Pharmaceutical companies usually perform safety testing of vaccines, but all requirements of the World Health Organization and drug pharmacopoeias depend on general toxicity testing, and the gene expression study of hepatitis B vaccine is not done routinely to test vaccine quality."
Could the gene-expression altering affects of hepatitis B vaccine be one reason why there are over 60 serious detrimental health effects associated with the vaccine as documented in the peer-reviewed and published biomedical literature, including sudden infant death?
Other potential mechanisms of action behind hepatitis B vaccine's dangerous side effects, are as follows...
Hepatitis B vaccines may contain Hepatitis B Virus polymerase as a contaminant, which may trigger an auto-immune process against the myelin (protective coating on the nerves) in some vaccinated subjects.
Hepatitis B vaccine may induced autoimmune demyelinating disease through the molecular mimicry that exists between the vaccine antigen, Epstein-Barr virus and human myelin.
Why Are They Vaccinating Infants For Hepatitis B Virus?
The real danger here is that universal vaccination against Hepatitis B virus may be causing far more harm than good. It is actually our youngest -- infants -- who are most at risk of being irreparably harmed, as the CDC's vaccine schedule requires Hepatitis B vaccination at birth, 1-2 months, and then again at 3-6 months of age.
Universal hepatitis B vaccination was recommended for U.S. newborns in 1991, despite contradictory safety findings. Perhaps not coincidentally, the prevalence of autism today is 1500% higher than that occurring in the period immediately before their introduction. While there is no such thing as a "genetic epidemic," in the traditional inheritable sense of the word "genetic," there is such a thing as environmentally induced gene-expression changes, as described above. In other words, vaccine adjuvants (e.g. mercury and aluminum) and vaccine antigens are capable of profoundly affecting the stability of the genetic infrastructure upon which our health depends.
According to one review published in the Journal of Toxicology and Environmental Health in 2010, male newborns vaccinated with hepatitis B prior to 1999 had a 3-fold higher risk for parentally reported autism. Why before 1999? On 8/27/99 the CDC, in tacit acknowledgment of the profound neurotoxicity associated with the use of thimerosal (organomercury), approved the first thimerosal-free hepatitis B vaccine. Sadly, even after the removal of mercury (which was replaced by another neurotoxic agent aluminum hydroxide), autism prevalence is still several orders of magnitude higher than it was before the CDC's increasingly overwhelming vaccine schedule (60+ by age 6) reached its present-day proportions.
Another glaring problem with Hep. B vaccine in infants is that Hepatitis B virus is only transmitted through blood or semen by those who are infected, which are two routes of exposure an infant -- certainly not one born in a hospital -- should ever be exposed to; unless, of course, the mother is a carrier, and therefore can transmit it vertically to her offspring. But hospitals can and should screen mothers for Hepatitis B preemptively, therefore making it unnecessary to vaccinate every infant blindly. In addition, there are no randomized controlled trials that have assessed the effects of hepatitis B vaccine during pregnancy for preventing infant infection, despite the fact that pregnant women are being given the vaccine for exactly this reason.2 There is also research indicating that immunization for Hepatitis B does not guarantee protection against becoming infected with it; i.e. it may not truly fall within the category of a vaccine-preventable disease.3
Contact Information
Research and Links
Via: Greenmedinfo
Startling new research published in the journal Apoptosis indicates that hepatitis B vaccine, which is designed to prevent Hepatitis B virus-induced damage to the liver, actually causes liver cell destruction.
In the study titled "Hepatitis B vaccine induces apoptotic death in Hepa1-6 cells," researchers set out to "...establish an in vitro model system amenable to mechanistic investigations of cytotoxicity induced by hepatitis B vaccine, and to investigate the mechanisms of vaccine-induced cell death."1
They found the hepatitis B vaccine induced a "loss of mitochondrial integrity, apoptosis induction, and cell death" in liver cells exposed to a low dose of adjuvanted hepatitis B vaccine. The adjuvant used was aluminum hydroxide, which is increasingly being identified as a contributing cause of autoimmune disease in immunized populations.
The discovery that the hepatitis B vaccine damages the liver (hepatotoxicity) confirms earlier findings (1999) that the vaccine increases the incidence of liver problems in U.S. children less than 6 years old by up to 294% versus unvaccinated controls.
Another study published in the journal Hepatogastroentology in 2002, observed that Hepatitis B vaccination was statistically associated with gastrointestinal reactions including: hepatitis, gastrointestinal disease and liver function test abnormalities in comparison to other vaccine control groups.
This, however, is only the tip of the iceberg...
In a revealing study published in June 2011 in the journal Molecular Biology Reports, researchers demonstrated that hepatitis B vaccine alters the expression of 144 genes in the mouse liver within 1 day of vaccination, 7 of which are related to inflammation and metabolism. The authors noted:
"Pharmaceutical companies usually perform safety testing of vaccines, but all requirements of the World Health Organization and drug pharmacopoeias depend on general toxicity testing, and the gene expression study of hepatitis B vaccine is not done routinely to test vaccine quality."
Could the gene-expression altering affects of hepatitis B vaccine be one reason why there are over 60 serious detrimental health effects associated with the vaccine as documented in the peer-reviewed and published biomedical literature, including sudden infant death?
Other potential mechanisms of action behind hepatitis B vaccine's dangerous side effects, are as follows...
Hepatitis B vaccines may contain Hepatitis B Virus polymerase as a contaminant, which may trigger an auto-immune process against the myelin (protective coating on the nerves) in some vaccinated subjects.
Hepatitis B vaccine may induced autoimmune demyelinating disease through the molecular mimicry that exists between the vaccine antigen, Epstein-Barr virus and human myelin.
Why Are They Vaccinating Infants For Hepatitis B Virus?
The real danger here is that universal vaccination against Hepatitis B virus may be causing far more harm than good. It is actually our youngest -- infants -- who are most at risk of being irreparably harmed, as the CDC's vaccine schedule requires Hepatitis B vaccination at birth, 1-2 months, and then again at 3-6 months of age.
Universal hepatitis B vaccination was recommended for U.S. newborns in 1991, despite contradictory safety findings. Perhaps not coincidentally, the prevalence of autism today is 1500% higher than that occurring in the period immediately before their introduction. While there is no such thing as a "genetic epidemic," in the traditional inheritable sense of the word "genetic," there is such a thing as environmentally induced gene-expression changes, as described above. In other words, vaccine adjuvants (e.g. mercury and aluminum) and vaccine antigens are capable of profoundly affecting the stability of the genetic infrastructure upon which our health depends.
According to one review published in the Journal of Toxicology and Environmental Health in 2010, male newborns vaccinated with hepatitis B prior to 1999 had a 3-fold higher risk for parentally reported autism. Why before 1999? On 8/27/99 the CDC, in tacit acknowledgment of the profound neurotoxicity associated with the use of thimerosal (organomercury), approved the first thimerosal-free hepatitis B vaccine. Sadly, even after the removal of mercury (which was replaced by another neurotoxic agent aluminum hydroxide), autism prevalence is still several orders of magnitude higher than it was before the CDC's increasingly overwhelming vaccine schedule (60+ by age 6) reached its present-day proportions.
Another glaring problem with Hep. B vaccine in infants is that Hepatitis B virus is only transmitted through blood or semen by those who are infected, which are two routes of exposure an infant -- certainly not one born in a hospital -- should ever be exposed to; unless, of course, the mother is a carrier, and therefore can transmit it vertically to her offspring. But hospitals can and should screen mothers for Hepatitis B preemptively, therefore making it unnecessary to vaccinate every infant blindly. In addition, there are no randomized controlled trials that have assessed the effects of hepatitis B vaccine during pregnancy for preventing infant infection, despite the fact that pregnant women are being given the vaccine for exactly this reason.2 There is also research indicating that immunization for Hepatitis B does not guarantee protection against becoming infected with it; i.e. it may not truly fall within the category of a vaccine-preventable disease.3
Contact Information
Apr 2, 2013
Two Autistic Children Awarded Millions by Vaccine Court
Autism Rates 1 in 50 Kids are Vaccines Responsible?
Research and links
Via: TheHealthyhomeeconomist
This is the favored approach the government and tow the line pundits in mainstream media take when it comes to the issue of whether vaccines cause autism.
Newspaper and magazine headlines and TV talking heads repeat the anthem ad nauseum that no link between vaccines and autism has been found and that parents need not be concerned about the uneducated, nonscientific “rumors” swirling on the internet that claim otherwise.
You have to wonder how the pro-vaccine lobby with its head hopelessly stuck in the sand is going to squelch this news.
Just days ago, the Vaccine Injury Compensation Program (VICP) also known as “vaccine court” awarded millions of dollars to two children who rapidly regressed and became autistic after a round of routine childhood vaccinations.
The first case involved a child named Emily who suffered a severe vaccine reaction to DTaP at 15 months old. MMR, HiB and Prevnar were also given at that time.
The second case involved 10 year old Ryan Mojabi of California in which the government admitted that the MMR vaccine caused the brain encephalopathy or brain dysfunction Ryan suffered within five to fifteen days of receiving the shot. Encephalopathy is considered a “vaccine table” injury, in other words, a compensable adverse reaction to vaccination.
Likely key to the prosecution was the testimony of family, friends, and neighbors of the children who testified under oath that the children were normal and perhaps even advanced for their age before autism took hold after routine immunizations.
Seizures, spiking fevers, a measles like rash of red spots all over the body and ultimately brain encephalopathy were reported following the shots. The witnesses said that the children never fully recovered from the adverse vaccine reactions they experienced, losing eye contact, language, and social skills – all hallmark symptoms of autism.
These are not the first cases of autistic children receiving compensation from vaccine court.
In two other cases (Polling and Banks), the government conceded that encephalopathy triggered after immunization did result in permanent brain injury and ultimately autism.
How Much Longer Can the Obvious Be Denied?
Very, very quietly and without any media attention to the matter, the cases keep piling up of vaccine court awarding compensation for children who became autistic after routine vaccination.
Vaccination proponents will no doubt argue that the autism that resulted was unrelated to the post immunization encephalopathy the children suffered which is the vaccine table injury that permitted the compensation to be awarded.
Those with any common sense will note that the encephalopathy or brain dysfunction suffered from the immunizations no doubt played a huge role and was most likely a key factor in the rapid, regressive autism these children experienced.
No matter whether you are for or against vaccination, one thing can be agreed upon: childhood vaccinations can and do indeed result in brain encephalopathy and permanent brain damage.
Whether or not this vaccine induced brain damage is called autism or not is nothing but a game of semantics.
Autism is as autism does.
Sarah, The Healthy Home Economist
Research and links
Via: TheHealthyhomeeconomist
This is the favored approach the government and tow the line pundits in mainstream media take when it comes to the issue of whether vaccines cause autism.
Newspaper and magazine headlines and TV talking heads repeat the anthem ad nauseum that no link between vaccines and autism has been found and that parents need not be concerned about the uneducated, nonscientific “rumors” swirling on the internet that claim otherwise.
You have to wonder how the pro-vaccine lobby with its head hopelessly stuck in the sand is going to squelch this news.
Just days ago, the Vaccine Injury Compensation Program (VICP) also known as “vaccine court” awarded millions of dollars to two children who rapidly regressed and became autistic after a round of routine childhood vaccinations.
The first case involved a child named Emily who suffered a severe vaccine reaction to DTaP at 15 months old. MMR, HiB and Prevnar were also given at that time.
The second case involved 10 year old Ryan Mojabi of California in which the government admitted that the MMR vaccine caused the brain encephalopathy or brain dysfunction Ryan suffered within five to fifteen days of receiving the shot. Encephalopathy is considered a “vaccine table” injury, in other words, a compensable adverse reaction to vaccination.
Likely key to the prosecution was the testimony of family, friends, and neighbors of the children who testified under oath that the children were normal and perhaps even advanced for their age before autism took hold after routine immunizations.
Seizures, spiking fevers, a measles like rash of red spots all over the body and ultimately brain encephalopathy were reported following the shots. The witnesses said that the children never fully recovered from the adverse vaccine reactions they experienced, losing eye contact, language, and social skills – all hallmark symptoms of autism.
These are not the first cases of autistic children receiving compensation from vaccine court.
In two other cases (Polling and Banks), the government conceded that encephalopathy triggered after immunization did result in permanent brain injury and ultimately autism.
How Much Longer Can the Obvious Be Denied?
Very, very quietly and without any media attention to the matter, the cases keep piling up of vaccine court awarding compensation for children who became autistic after routine vaccination.
Vaccination proponents will no doubt argue that the autism that resulted was unrelated to the post immunization encephalopathy the children suffered which is the vaccine table injury that permitted the compensation to be awarded.
Those with any common sense will note that the encephalopathy or brain dysfunction suffered from the immunizations no doubt played a huge role and was most likely a key factor in the rapid, regressive autism these children experienced.
No matter whether you are for or against vaccination, one thing can be agreed upon: childhood vaccinations can and do indeed result in brain encephalopathy and permanent brain damage.
Whether or not this vaccine induced brain damage is called autism or not is nothing but a game of semantics.
Autism is as autism does.
Sarah, The Healthy Home Economist
Apr 1, 2013
Nano Patch Vaccination Funded by the Gates Foundation
Via: The Verge
Researchers have proved that "injection-free" vaccines are an effective tool in the fight against diseases. The team, based in King's College London and funded by the Bill & Melinda Gates Foundation, used dried sugar to create a microneedle array — a tiny disc that only lightly perforates the skin. The dried sugar, which was laced with a proposed HIV vaccine, dissolves when inserted in to the skin, effectively delivering the vaccine and kick-starting an immune response. The method is far less invasive than conventional vaccines that are delivered via a hypodermic needle.
Other benefits to the microneedle array include preservation; many traditional liquid vaccines need to be kept at extremely low temperatures, which is a major barrier to transportation. The researchers' dried vaccine, however, remained as stable and effective at room temperature as the same dose of liquid vaccine preserved at minus 80 degrees Celsius.
The team's findings, which expand on years of research across the globe, could help lower the cost of vaccinations across the globe. Dr Linda Klavinskis of Kings College says the work "could potentially reduce the cost of manufacturing and transportation" as there would be no need for refrigeration, as well lowering the risk of transmitting diseases through contaminated needles and syringes. The team hopes to one day use the method to vaccinate against HIV, malaria, and tuberculosis; three global issues that the Bill & Melinda Gates Foundation is focused on fixing.
The Mosquito War's: West Nile Virus Nano Vaccine Patch
Self-Administering Micro Flu Vaccine Patch Sent Via Mail!
Researchers have proved that "injection-free" vaccines are an effective tool in the fight against diseases. The team, based in King's College London and funded by the Bill & Melinda Gates Foundation, used dried sugar to create a microneedle array — a tiny disc that only lightly perforates the skin. The dried sugar, which was laced with a proposed HIV vaccine, dissolves when inserted in to the skin, effectively delivering the vaccine and kick-starting an immune response. The method is far less invasive than conventional vaccines that are delivered via a hypodermic needle.
Other benefits to the microneedle array include preservation; many traditional liquid vaccines need to be kept at extremely low temperatures, which is a major barrier to transportation. The researchers' dried vaccine, however, remained as stable and effective at room temperature as the same dose of liquid vaccine preserved at minus 80 degrees Celsius.
The team's findings, which expand on years of research across the globe, could help lower the cost of vaccinations across the globe. Dr Linda Klavinskis of Kings College says the work "could potentially reduce the cost of manufacturing and transportation" as there would be no need for refrigeration, as well lowering the risk of transmitting diseases through contaminated needles and syringes. The team hopes to one day use the method to vaccinate against HIV, malaria, and tuberculosis; three global issues that the Bill & Melinda Gates Foundation is focused on fixing.
The Mosquito War's: West Nile Virus Nano Vaccine Patch
Self-Administering Micro Flu Vaccine Patch Sent Via Mail!
Mar 29, 2013
Nursing Students Required to get Flu Shots
Via: TheShortHorn
While some students have to decide whether they want a flu shot, other students don't have a choice. A flu shot is mandatory for UTA nursing student before starting their clinical rotations. A clinical rotation is time a student spends at a hospital to get nursing experience. Clinical instructor Deborah Hughes said a flu shot is mandatory because the institutions they attend for clinical rotations require the students to get the shot. “The reason for that is because nurses and students are taking care of very sick patients, and if that student or nurse has the flu, they can give it to that very sick patient and that can be detrimental to the patient’s wellness," she said. Nursing junior Angie Espinoza said she didn't get the flu shot until she joined the nursing program. “I never got the flu shot because of my personal opinion," she said. "I really don’t see the point of it, but the shot is required, so I got it.” But there may be UTA nursing students who have allergic reactions to eggs or egg whites or have religious beliefs against shots and, therefore, cannot get the flu shot. If that is the case, there has to be documentation showing proof for why they cannot get.
UTA nursing students can still go to clinical rotations without getting the shot, but there are several things that must be done first. Hughes said students would have to sign a waiver and follow any precautions the hospitals give to the students. “They just have to sign a form that says why they didn’t get the flu shot and let the institutions be aware they do not have the flu shot," she said. “Some of the hospitals will make you wear a mask when caring for the patients.” Nursing junior Blanca Garcia said she got the flu shot and about a week later felt flu-like symptoms. She hadn't started her clinical rotations yet, but she still went to UTA's Smart Hospital for training. “I felt really bad but still went to the Smart Hospital because I didn’t want to miss any learning,” she said.
If a student does get sick and has to miss clinical rotations, Hughes said they have to call the faculty member prior to starting the clinical rotation and the student has to make up that time. “We will provide them with a case study. It's additional paperwork they would have to do or an alternate clinic site to make up the time," she said. "Also, it depends on the faculty member and the course, what else needs to be done. For the students to pass their clinical, they have to attend all the clinical hours that are required by the course because all of our clinicals are passed or failed.”
Contact Information
EVDN Homepage
PLEASE SHARE THIS INFORMATION
While some students have to decide whether they want a flu shot, other students don't have a choice. A flu shot is mandatory for UTA nursing student before starting their clinical rotations. A clinical rotation is time a student spends at a hospital to get nursing experience. Clinical instructor Deborah Hughes said a flu shot is mandatory because the institutions they attend for clinical rotations require the students to get the shot. “The reason for that is because nurses and students are taking care of very sick patients, and if that student or nurse has the flu, they can give it to that very sick patient and that can be detrimental to the patient’s wellness," she said. Nursing junior Angie Espinoza said she didn't get the flu shot until she joined the nursing program. “I never got the flu shot because of my personal opinion," she said. "I really don’t see the point of it, but the shot is required, so I got it.” But there may be UTA nursing students who have allergic reactions to eggs or egg whites or have religious beliefs against shots and, therefore, cannot get the flu shot. If that is the case, there has to be documentation showing proof for why they cannot get.
UTA nursing students can still go to clinical rotations without getting the shot, but there are several things that must be done first. Hughes said students would have to sign a waiver and follow any precautions the hospitals give to the students. “They just have to sign a form that says why they didn’t get the flu shot and let the institutions be aware they do not have the flu shot," she said. “Some of the hospitals will make you wear a mask when caring for the patients.” Nursing junior Blanca Garcia said she got the flu shot and about a week later felt flu-like symptoms. She hadn't started her clinical rotations yet, but she still went to UTA's Smart Hospital for training. “I felt really bad but still went to the Smart Hospital because I didn’t want to miss any learning,” she said.
If a student does get sick and has to miss clinical rotations, Hughes said they have to call the faculty member prior to starting the clinical rotation and the student has to make up that time. “We will provide them with a case study. It's additional paperwork they would have to do or an alternate clinic site to make up the time," she said. "Also, it depends on the faculty member and the course, what else needs to be done. For the students to pass their clinical, they have to attend all the clinical hours that are required by the course because all of our clinicals are passed or failed.”
Contact Information
EVDN Homepage
PLEASE SHARE THIS INFORMATION
Mar 28, 2013
Can A Video Game Alleviate Flu Shot Fears in Children?
Predictive programming at its finest with a video game to condition the kids to associate the fun of playing games with the innate fears of being injected with poisons.
Via: NBC
Doctors and a team of college video game designers have collaborated on a new video game they hope will alleviate children's fears about getting a flu shot.
The flu shot can be scary especially for 10-year-olds like Nick Hernandez.
"I'm not a fan of the needle."
Enter Flu-Busters, a video game designed to help kids with their fears of getting the flu shot.
"When we looked ... A lot of our patients, especially the adolescents, were not getting immunized."
To turn his idea about a flu video game into reality, Krilov turned to ... Who else? Big kids.
"I hated needles, too but I hated getting the flu more."
Senior Sam Zarahn was part of a team of video game students who worked with professor Elena Bertozzi to design the game in just a couple of months.
"We sat around thinking, 'How can we make getting a shot something kids would want to do?'"
The ten minute game puts kids in different school situations where they're exposed to flu germs.
If they make the right choices, they can walk away without getting sick.
"The biggest challenge for designers was making it fun for kids... Their answer was to create a superhero named Vaccine Man and to turn flu germs into a disgusting green villain."
"I just wanted to create something that was gross"
Gross or not hospital staff have been testing the game on kids at outpatient clinics.
So far all the youngsters who have seen it have agreed to get a flu shot.
"But now I understand the dangers of the flu."
The hospital hopes to make the game available to kids everywhere.
Via: NBC
Doctors and a team of college video game designers have collaborated on a new video game they hope will alleviate children's fears about getting a flu shot.
The flu shot can be scary especially for 10-year-olds like Nick Hernandez.
"I'm not a fan of the needle."
Enter Flu-Busters, a video game designed to help kids with their fears of getting the flu shot.
"When we looked ... A lot of our patients, especially the adolescents, were not getting immunized."
To turn his idea about a flu video game into reality, Krilov turned to ... Who else? Big kids.
"I hated needles, too but I hated getting the flu more."
Senior Sam Zarahn was part of a team of video game students who worked with professor Elena Bertozzi to design the game in just a couple of months.
"We sat around thinking, 'How can we make getting a shot something kids would want to do?'"
The ten minute game puts kids in different school situations where they're exposed to flu germs.
If they make the right choices, they can walk away without getting sick.
"The biggest challenge for designers was making it fun for kids... Their answer was to create a superhero named Vaccine Man and to turn flu germs into a disgusting green villain."
"I just wanted to create something that was gross"
Gross or not hospital staff have been testing the game on kids at outpatient clinics.
So far all the youngsters who have seen it have agreed to get a flu shot.
"But now I understand the dangers of the flu."
The hospital hopes to make the game available to kids everywhere.
Mar 27, 2013
Research to resume on deadly artificial strain of H5N1 virus
Via: South China Morning Post
Experiments with a deadly, artificially mutated version of the bird flu virus are set to resume in a few weeks, ending a year-long suspension in research prompted by a global outcry over the risks.
Two groups of scientists in the Netherlands and the US altered the H5N1 virus to make it easily transmissible among mammals. Some scientists warned that a deadly pandemic could break out if the mutant virus escaped accidentally or if terrorists stole it or made it themselves, using articles in scientific journals .
The outcry led scientists conducting the experiments to declare a voluntary moratorium a year ago, in part to let research institutes and governments decide what safety rules to require.
Now, flu researchers say, the moratorium should end because most countries have rules in place. A letter from the same 40 scientists who called for the moratorium last year was published yesterday in the journals Science and Nature, saying it is time for the work to begin again in countries ready to allow it. Signatories include Hong Kong researchers Guan Yi and Malik Peiris.
Leo Poon Lit-man, associate professor at the University of Hong Kong's school of public health, said the university had no plans so far for research to make the bird flu virus stronger or more transmissible. He said a group of researchers signed the letter as a gesture to support the controversial research .
"The only way … to control the virus and come to a prevention plan is to allow the research to go forward," Poon said. Though he has not signed the letter himself, he spoke on behalf of the research team that supported the move, including researchers Yi and Peiris.
"The issue is highly controversial and we understand different people hold different points of view. H5N1 is still a threat to humans, and it is true that the research may pose some risk. But we may also benefit from it, as we need further understanding of the virus to ensure a better response in case of an outbreak.
"We think it is time to draw a conclusion that the research has to go on," Poon said.
Researchers will restart projects in countries where governments have approved biosecurity measures, according to the letter signed by 40 researchers. This does not currently include the US, the scientists wrote.
The US is expected to approve its own rules for dealing with the mutant virus within weeks.
Ron Fouchier, a virologist who conducted some of the original experiments at the Erasmus Medical Centre in the Netherlands, said research was needed to test the effectiveness of vaccines and antiviral medications against a mutated virus that could be spread by mammals.
The first cases of H5N1 emerged in Hong Kong in 1997, setting off alarm bells worldwide. Six of the 18 victims died. It re-emerged in 2003 in Southeast Asia and other countries, infecting some 600 with a mortality rate of almost 60 per cent, according to the Geneva-based WHO.
All but a few victims have caught the disease from birds. Scientists' worst fear is the virus spreading among mammals.
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Experiments with a deadly, artificially mutated version of the bird flu virus are set to resume in a few weeks, ending a year-long suspension in research prompted by a global outcry over the risks.
Two groups of scientists in the Netherlands and the US altered the H5N1 virus to make it easily transmissible among mammals. Some scientists warned that a deadly pandemic could break out if the mutant virus escaped accidentally or if terrorists stole it or made it themselves, using articles in scientific journals .
The outcry led scientists conducting the experiments to declare a voluntary moratorium a year ago, in part to let research institutes and governments decide what safety rules to require.
Now, flu researchers say, the moratorium should end because most countries have rules in place. A letter from the same 40 scientists who called for the moratorium last year was published yesterday in the journals Science and Nature, saying it is time for the work to begin again in countries ready to allow it. Signatories include Hong Kong researchers Guan Yi and Malik Peiris.
Leo Poon Lit-man, associate professor at the University of Hong Kong's school of public health, said the university had no plans so far for research to make the bird flu virus stronger or more transmissible. He said a group of researchers signed the letter as a gesture to support the controversial research .
"The only way … to control the virus and come to a prevention plan is to allow the research to go forward," Poon said. Though he has not signed the letter himself, he spoke on behalf of the research team that supported the move, including researchers Yi and Peiris.
"The issue is highly controversial and we understand different people hold different points of view. H5N1 is still a threat to humans, and it is true that the research may pose some risk. But we may also benefit from it, as we need further understanding of the virus to ensure a better response in case of an outbreak.
"We think it is time to draw a conclusion that the research has to go on," Poon said.
Researchers will restart projects in countries where governments have approved biosecurity measures, according to the letter signed by 40 researchers. This does not currently include the US, the scientists wrote.
The US is expected to approve its own rules for dealing with the mutant virus within weeks.
Ron Fouchier, a virologist who conducted some of the original experiments at the Erasmus Medical Centre in the Netherlands, said research was needed to test the effectiveness of vaccines and antiviral medications against a mutated virus that could be spread by mammals.
The first cases of H5N1 emerged in Hong Kong in 1997, setting off alarm bells worldwide. Six of the 18 victims died. It re-emerged in 2003 in Southeast Asia and other countries, infecting some 600 with a mortality rate of almost 60 per cent, according to the Geneva-based WHO.
All but a few victims have caught the disease from birds. Scientists' worst fear is the virus spreading among mammals.
Contact Information
EVDN Homepage
PLEASE SHARE THIS INFORMATION
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