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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Apr 12, 2013
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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