Rotarix Vaccine
FDA Sees Possible Risk of Fatal Bowel Problem With GSK Vaccine
The Food and Drug Administration said preliminary results from a study in Mexico involving GlaxoSmithKline's Rotarix vaccine suggest an increased risk of a serious bowel problem that could be fatal. A statement posted to the FDA's website said the study showed an increased risk of intussusception in the 31-day period following the first dose of Rotarix. Intussusception is a twisting or obstruction of the intestine that can be fatal.
The safety of Rotarix and RotaTeq, a similar vaccine made by Merck, have carefully been tracked by regulators since another vaccine by then drug-maker Wyeth was pulled off the market in 1999 after it was linked to an increased rate of intussusception.
What Dr. Mercola says :
GlaxoSmithKline's Rotarix vaccine has been plagued with problems since its approval in 2008, not the least of which is this alarming link to intussusception, a potentially fatal problem with the intestine in which one portion of the bowel slides into the next.
Preliminary results from a Mexican study found an increased risk of intussusception within 31 days following vaccination with Rotarix, with most cases occurring within the first seven days. Unfortunately, the vaccine will still remain on the market until the U.S. Food and Drug Administration (FDA) has a chance to review the final study results sometime next year.
Yet you only need to look at the past history of rotavirus vaccines to know that this is a disaster in progress …
Similar Rotavirus Vaccine Pulled From Market for This Very Same Problem Rotarix is intended to prevent rotavirus disease, which causes diarrhea and dehydration. A similar oral rotavirus vaccine was actually pulled from the market in 1999 after nine reports of intussusception occurred within the first 7 months of vaccine use, more than double the cases reported in the previous seven years.
Meanwhile, in 2007, the FDA also issued an advisory warning about RotaTeq (a rotavirus vaccine made by Merck). For what? The risk of intussusception, in which 16 of the 28 reported cases required surgery to repair a baby's intestinal tract.
Given this track record with rotavirus vaccines, it is appalling that the FDA is not taking urgent action to protect the children, but then this is the same agency that approved Rotarix in the first place -- even though there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies.
It's also the same agency that only "recommended" physicians temporarily suspend their use of Rotarix earlier this year after a serious contamination risk was uncovered …
Rotarix Contaminated by Pig Virus As though the risks of intussusception are not bad enough, a research team revealed that Rotarix was contaminated with "a substantial amount" of DNA from a pig virus.
Somewhat by accident, Dr. Eric Delwart and colleagues, who were intending to "show that live attenuated vaccine only contained the expected viral genomes and no other," discovered that Rotarix contained "significant levels" of porcine cirovirus 1. Rotateq, Merck's rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus.
Both the FDA and GlaxoSmithKline spokespeople continue to state that no safety risk has been uncovered from the contamination, at least not yet. But what are they going to say? The vaccine has already been given to 1 million U.S. children, and about 30 million worldwide, who must now live with the consequences of this contaminated vaccine, whatever they may be.
Carefully Research before Getting Your Kids Vaccinated for Rotavirus Clearly these vaccines, including the two still on the market, are causing a disturbance serious enough that a typically rare bowel problem is becoming all too common.
Before taking this potential risk with your child, you must get informed on the risks of rotavirus … the disease the vaccine is intended to prevent.
Rotavirus is very contagious and does cause more than 500,000 deaths in young children each year, but this is mostly in developing countries. In the United States, rotavirus is responsible for only "several dozen" deaths a year, according to FDA Commissioner Dr. Margaret Hamburg.
Typically, when a child in the United States contracts rotavirus, and most do, only rest and fluids are required to recover. This infection also provides natural immunity that will protect your child for life.
As the National Vaccine Information Center writes:
"The CDC estimates that, by age 3, almost every US child has had a case of rotavirus. Once a child has been infected with a strain of rotavirus, he or she develops antibodies and is either immune for life or has a milder case if infected with that same strain in the future.
Most healthy children, who are infected with several strains of rotavirus in the first few years of life, develop lifelong natural immunity to rotavirus infection."
So in most cases, if you live in a developed country there is absolutely no need to get the vaccine in the first place. And even now that vaccination is widespread, the vaccine appears to be having virtually NO effect on rotavirus rates. According to NVIC:
"Today, even though almost all US infants receive vaccines for rotavirus, and despite efforts to improve the management of childhood rotavirus-associated diarrhea, hospitalizations of children in the U.S. with the disease have not significantly declined in the past two decades."
It even states right on GSK's Web site that "Vaccination with ROTARIX may not provide 100% protection to all recipients." The site also reveals the fact that safety has not been established for all infants:
"Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated."
So with this particular vaccine, children are taking on serious risks with little to no benefit.
The question U.S. parents need to ask is, would I rather risk my child getting a mild disease that requires rest and fluids for recovery -- and then affords them lifelong immunity -- or risk getting them vaccinated and having them suffer from a potentially fatal intestinal blockage or some other unknown side effect?
With this and all vaccines, it's necessary to always weigh the risks versus the benefits, as often you'll find that the risks come out on top.
My Appeal to You Don’t sit this one out! We’ve got them “on the run.”
Tell everyone. Tell your friends, your family. With a little bit of effort, you can make significant strides toward preserving your freedom to make voluntary health decisions affecting your and your children’s future.
One of the top goals for the National Vaccine Information Center (NVIC) is preserving your freedom of choice about if and when to use vaccines. As part of that mission, this non-profit charity has been fighting for your right to make informed VOLUNTARY vaccine choices since 1982.
During the upcoming Vaccine Awareness Week, NVIC is launching the online NVIC State Advocacy Portal that will give you the tools you need to take action to protect legal medical, religious and conscientious belief exemptions to vaccination in YOUR state.
Mercola.com & NVIC Dedicating November 1-6 Vaccine Awareness Week In a long-scheduled joint effort to raise public awareness about important vaccination issues during the week of November 1-6, 2010, Mercola.com and NVIC will publish a series of articles and interviews on vaccine topics of interest to Mercola.com newsletter subscribers and NVIC Vaccine E-newsletter readers.
The week-long public awareness program will also raise funds for NVIC, a non-profit charity that has been working for more than two decades to prevent vaccine injuries and deaths through public education and protecting informed consent to vaccination.
The November 1-6 Vaccine Awareness Week hosted by Mercola.com and NVIC will follow a month-long vaccine awareness effort in October that was recently announced on Facebook by parents highlighting Gardasil vaccine risks.
The six-week-long focus this fall on vaccine issues will help raise the consciousness of many more Americans, who may be unaware that they can take an active role in helping to prevent vaccine injuries and deaths and defend the legal right to make voluntary vaccination choices.
And remember, you can always visit Vaccines.Mercola.com and NVIC.org for the latest vaccine news updates and other important vaccine information.
Source : Dr. Mercola
LINK TO SOURCE
Vaccine Contamination: Pig Virus DNA Found in Rotarix
On March 22, 2010, Food and Drug Administration (FDA) officials adhering to the precautionary principle advised American doctors to suspend use of Rotarix 1 vaccine until the agency finds out why DNA from a swine virus (porcine circovirus 1 or PCV1) was found in the live rotavirus vaccine. The FDA said there is “no evidence at this time” that the vaccine manufactured by GlaxoSmithKline and given to babies at 2,4 and 6 months of age to prevent diarrhea poses any safety risk. 2
Independent Lab Using New Technology Found Contamination The discovery that viral DNA is contaminating Rotarix vaccine was made by a team of scientists at an independent research lab in San Fransisco, California, where they used new technology to detect fragments of viral genetic material in vaccines using genetic sequencing. 3
More testing confirmed that many copies of DNA from the pig virus were present in all Rotarix vaccine lots released since the vaccine was licensed in 2008 because the pig virus DNA also contaminated the working cell bank and the original viral “seed” stock, from which Rotarix vaccine was first produced. 4
Two Other Live Virus Vaccines Contaminated
The surprising discovery reportedly was made after the independent lab used new technology to evaluate the purity of eight live virus vaccines for polio, rubella, measles, yellow fever, human herpes 3 (varicella or chicken pox), rotavirus (Rotarix and RotaTeq) and MMR. In addition to pig viral DNA found in Rotarix vaccine, low levels of DNA fragments from avian (bird) leukosis virus (a retrovirus) was found in measles vaccine and DNA fragments of a virus similar to simian (monkey) retrovirus was found in RotaTeq vaccine. 5
FDA Looking For Answers
After the team double checked their findings, researchers notified GlaxoSmithKline (GSK) on February 9, 2010 and GSK notified the FDA on March 15, 2010, which prompted the FDA’s action on March 22, 2010 to suspend use of Rotarix. The FDA says it “does not know how DNA from PCV1 came to be present in Rotarix” or whether “this means that intact virus is present. Additional studies are being conducted.” 6
Rotavirus Vaccines Use Monkey, Cow, Pig Materials for Production
Rotarix is a genetically engineered vaccine that GSK created by isolating human rotavirus strain infecting a child in Cincinnati and using African Green monkey kidney cells to produce the original viral seed stock from which all Rotarix vaccine has been made. 7 In the FDA licensing process, Rotarix had to meet certain FDA standards, that included demonstrating the vaccine was not contaminated with, for example TSE(Transmissable Spongiform Encephalopathy or “mad cow” disease, a brain wasting disease) 8 or with cow viruses because bovine (cow) serum was used to prepare the original viral seed stock. Porcine trypsin, an enzyme in the pancreatic juice of a pig, was also used to make the viral seed stock. 9
RotaTeq is a genetically engineered vaccine containing five human-cow reassortment strains of rotavirus that were created at the Children’s Hospital of Pennsylvania (CHOP), where strains of rotavirus that give cows diarrhea were combined with strains of rotavirus that cause diarrhea in humans. The reassortment viruses were transported to Merck, where master seeds were produced using African Green Monkey kidney cell cultures. Fetal bovine (cow) serum and porcine trypsin was used to make the “seed” stock. 10 There are small amounts of bovine serum and cell culture media (monkey viral DNA) that remain in RotaTeq vaccine. 11 12
FDA Suggests Drug Companies Test for Vaccine “Purity”
In a February 2010 FDA document, Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, the FDA lists “non-binding recommendations” for drug companies making vaccines using animal and human cell substrates. 13 Under the heading “Testing for Adventitious Agents,” the FDA states “assurance that products are free of adventitious agents is a critical component of meeting the [FDA regulations] requirement for purity.” Under the heading “Testing for Residual Cellular DNA,” the FDA states, “Residual DNA might be a risk to your final product because of oncogenic (cancer causing) and/or infectivity potential.”
Déjà Vu: Monkey Viruses Contaminated Polio Vaccines
Contamination of vaccines with animal viruses is not new. In the 20th century, polio vaccines given to tens of millions of people worldwide were contaminated with simian virus 40 (SV40), which was found to cause cancer in animals and is associated with human brain, bone and lung cancers but the government denies SV40 is causing those cancers in humans. 14 15 16 17
There has been controversy about the link between experimental polio vaccines tested in Africa in the 1950’s and 1960’s that were contaminated with a monkey virus, simian immunodeficiency virus (SIV). Soon after the polio vaccine trials in Africa, the human immunodeficiency virus (HIV) emerged. 18 Many questions about the failure of researchers and technology to screen for monkey viruses in those vaccines remain to this day.
Using Cancer Cells to Produce Vaccines?
Vaccine manufacturers have long used cell material that comes from the bodies of mammals, including humans, monkeys, cows, pigs, dogs and rodents, as well as birds or insects to make vaccines now in use or to make experimental vaccines. There is an inherent risk of contamination with viruses and other microbes (or DNA from those microbes) that can escape detection during the vaccine development, testing, licensing, manufacturing and oversight process. 19 There has even been discussion among vaccine manufacturers and the FDA in the last decade about using neoplastic (cancer)cell substrates to make vaccines but the risk of contamination with cancer cell DNA is a big risk. 20
New Influenza Vaccines: Is Contamination Possible?
In searching for ways to make seasonal influenza vaccines in a faster, easier and less expensive way than relying on chicken eggs for production, drug companies have experimented with using dog kidney cells and human fetal retinal cells. However, these cell lines have been documented to cause tumors in animals, especially dog kidney cells (MDCK). 21
At a November 19, 2009 meeting of the FDA Vaccines & Related Biological Products Advisory Committee, a vaccine manufacturer asked for permission to use insect (caterpillar) cells to make pandemic influenza shots. But insect cells can be contaminated with insect viruses that are hard to detect. The FDA Committee, on that day, voted “no.” 22
Unanswered Questions about Rotarix Contamination
There are lots of questions about how the manufacturer of Rotarix vaccine and the FDA both missed the pig virus DNA contaminating the original seed stock and all doses of Rotarix vaccine given to more than one million American children in the past few years. 23
Is there state-of-the-art technology that is being used by private laboratories but not by drug companies and the FDA?
Why did the independent team of scientists, who found the contamination, notify the vaccine manufacturer first rather than also immediately reporting their finding directly to the FDA?
What about the significance of finding bird viral DNA in measles vaccine and the monkey viral DNA in RotaTeq vaccine?
Wake Up Call for Industry & Government
The contamination of Rotarix vaccine is only the latest in a long history of vaccine contamination issues that require a re-examination of the way vaccines are made and tested. It is a wake-up call for industry and government
The big question people are asking is: why do drug companies making vaccines continue to use cells from animals, birds and insects that can be contaminated with viruses and other adventitious agents that are hard to detect?
The FDA was right to suspend use of Rotarix vaccine until they know more. Hopefully, this serious vaccine production and testing issue will be addressed immediately by vaccine manufacturers. If not, the next pandemic or serious health problem affecting large populations may be one that comes out of a vaccine lab.
SOURCE: NATIONAL VACCINE INFORMATION CENTRE
LINK TO SOURCE + VIDEO
The Food and Drug Administration said preliminary results from a study in Mexico involving GlaxoSmithKline's Rotarix vaccine suggest an increased risk of a serious bowel problem that could be fatal. A statement posted to the FDA's website said the study showed an increased risk of intussusception in the 31-day period following the first dose of Rotarix. Intussusception is a twisting or obstruction of the intestine that can be fatal.
The safety of Rotarix and RotaTeq, a similar vaccine made by Merck, have carefully been tracked by regulators since another vaccine by then drug-maker Wyeth was pulled off the market in 1999 after it was linked to an increased rate of intussusception.
What Dr. Mercola says :
GlaxoSmithKline's Rotarix vaccine has been plagued with problems since its approval in 2008, not the least of which is this alarming link to intussusception, a potentially fatal problem with the intestine in which one portion of the bowel slides into the next.
Preliminary results from a Mexican study found an increased risk of intussusception within 31 days following vaccination with Rotarix, with most cases occurring within the first seven days. Unfortunately, the vaccine will still remain on the market until the U.S. Food and Drug Administration (FDA) has a chance to review the final study results sometime next year.
Yet you only need to look at the past history of rotavirus vaccines to know that this is a disaster in progress …
Similar Rotavirus Vaccine Pulled From Market for This Very Same Problem Rotarix is intended to prevent rotavirus disease, which causes diarrhea and dehydration. A similar oral rotavirus vaccine was actually pulled from the market in 1999 after nine reports of intussusception occurred within the first 7 months of vaccine use, more than double the cases reported in the previous seven years.
Meanwhile, in 2007, the FDA also issued an advisory warning about RotaTeq (a rotavirus vaccine made by Merck). For what? The risk of intussusception, in which 16 of the 28 reported cases required surgery to repair a baby's intestinal tract.
Given this track record with rotavirus vaccines, it is appalling that the FDA is not taking urgent action to protect the children, but then this is the same agency that approved Rotarix in the first place -- even though there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies.
It's also the same agency that only "recommended" physicians temporarily suspend their use of Rotarix earlier this year after a serious contamination risk was uncovered …
Rotarix Contaminated by Pig Virus As though the risks of intussusception are not bad enough, a research team revealed that Rotarix was contaminated with "a substantial amount" of DNA from a pig virus.
Somewhat by accident, Dr. Eric Delwart and colleagues, who were intending to "show that live attenuated vaccine only contained the expected viral genomes and no other," discovered that Rotarix contained "significant levels" of porcine cirovirus 1. Rotateq, Merck's rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus.
Both the FDA and GlaxoSmithKline spokespeople continue to state that no safety risk has been uncovered from the contamination, at least not yet. But what are they going to say? The vaccine has already been given to 1 million U.S. children, and about 30 million worldwide, who must now live with the consequences of this contaminated vaccine, whatever they may be.
Carefully Research before Getting Your Kids Vaccinated for Rotavirus Clearly these vaccines, including the two still on the market, are causing a disturbance serious enough that a typically rare bowel problem is becoming all too common.
Before taking this potential risk with your child, you must get informed on the risks of rotavirus … the disease the vaccine is intended to prevent.
Rotavirus is very contagious and does cause more than 500,000 deaths in young children each year, but this is mostly in developing countries. In the United States, rotavirus is responsible for only "several dozen" deaths a year, according to FDA Commissioner Dr. Margaret Hamburg.
Typically, when a child in the United States contracts rotavirus, and most do, only rest and fluids are required to recover. This infection also provides natural immunity that will protect your child for life.
As the National Vaccine Information Center writes:
"The CDC estimates that, by age 3, almost every US child has had a case of rotavirus. Once a child has been infected with a strain of rotavirus, he or she develops antibodies and is either immune for life or has a milder case if infected with that same strain in the future.
Most healthy children, who are infected with several strains of rotavirus in the first few years of life, develop lifelong natural immunity to rotavirus infection."
So in most cases, if you live in a developed country there is absolutely no need to get the vaccine in the first place. And even now that vaccination is widespread, the vaccine appears to be having virtually NO effect on rotavirus rates. According to NVIC:
"Today, even though almost all US infants receive vaccines for rotavirus, and despite efforts to improve the management of childhood rotavirus-associated diarrhea, hospitalizations of children in the U.S. with the disease have not significantly declined in the past two decades."
It even states right on GSK's Web site that "Vaccination with ROTARIX may not provide 100% protection to all recipients." The site also reveals the fact that safety has not been established for all infants:
"Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated."
So with this particular vaccine, children are taking on serious risks with little to no benefit.
The question U.S. parents need to ask is, would I rather risk my child getting a mild disease that requires rest and fluids for recovery -- and then affords them lifelong immunity -- or risk getting them vaccinated and having them suffer from a potentially fatal intestinal blockage or some other unknown side effect?
With this and all vaccines, it's necessary to always weigh the risks versus the benefits, as often you'll find that the risks come out on top.
My Appeal to You Don’t sit this one out! We’ve got them “on the run.”
Tell everyone. Tell your friends, your family. With a little bit of effort, you can make significant strides toward preserving your freedom to make voluntary health decisions affecting your and your children’s future.
One of the top goals for the National Vaccine Information Center (NVIC) is preserving your freedom of choice about if and when to use vaccines. As part of that mission, this non-profit charity has been fighting for your right to make informed VOLUNTARY vaccine choices since 1982.
During the upcoming Vaccine Awareness Week, NVIC is launching the online NVIC State Advocacy Portal that will give you the tools you need to take action to protect legal medical, religious and conscientious belief exemptions to vaccination in YOUR state.
Mercola.com & NVIC Dedicating November 1-6 Vaccine Awareness Week In a long-scheduled joint effort to raise public awareness about important vaccination issues during the week of November 1-6, 2010, Mercola.com and NVIC will publish a series of articles and interviews on vaccine topics of interest to Mercola.com newsletter subscribers and NVIC Vaccine E-newsletter readers.
The week-long public awareness program will also raise funds for NVIC, a non-profit charity that has been working for more than two decades to prevent vaccine injuries and deaths through public education and protecting informed consent to vaccination.
The November 1-6 Vaccine Awareness Week hosted by Mercola.com and NVIC will follow a month-long vaccine awareness effort in October that was recently announced on Facebook by parents highlighting Gardasil vaccine risks.
The six-week-long focus this fall on vaccine issues will help raise the consciousness of many more Americans, who may be unaware that they can take an active role in helping to prevent vaccine injuries and deaths and defend the legal right to make voluntary vaccination choices.
And remember, you can always visit Vaccines.Mercola.com and NVIC.org for the latest vaccine news updates and other important vaccine information.
Source : Dr. Mercola
LINK TO SOURCE
Vaccine Contamination: Pig Virus DNA Found in Rotarix
On March 22, 2010, Food and Drug Administration (FDA) officials adhering to the precautionary principle advised American doctors to suspend use of Rotarix 1 vaccine until the agency finds out why DNA from a swine virus (porcine circovirus 1 or PCV1) was found in the live rotavirus vaccine. The FDA said there is “no evidence at this time” that the vaccine manufactured by GlaxoSmithKline and given to babies at 2,4 and 6 months of age to prevent diarrhea poses any safety risk. 2
Independent Lab Using New Technology Found Contamination The discovery that viral DNA is contaminating Rotarix vaccine was made by a team of scientists at an independent research lab in San Fransisco, California, where they used new technology to detect fragments of viral genetic material in vaccines using genetic sequencing. 3
More testing confirmed that many copies of DNA from the pig virus were present in all Rotarix vaccine lots released since the vaccine was licensed in 2008 because the pig virus DNA also contaminated the working cell bank and the original viral “seed” stock, from which Rotarix vaccine was first produced. 4
Two Other Live Virus Vaccines Contaminated
The surprising discovery reportedly was made after the independent lab used new technology to evaluate the purity of eight live virus vaccines for polio, rubella, measles, yellow fever, human herpes 3 (varicella or chicken pox), rotavirus (Rotarix and RotaTeq) and MMR. In addition to pig viral DNA found in Rotarix vaccine, low levels of DNA fragments from avian (bird) leukosis virus (a retrovirus) was found in measles vaccine and DNA fragments of a virus similar to simian (monkey) retrovirus was found in RotaTeq vaccine. 5
FDA Looking For Answers
After the team double checked their findings, researchers notified GlaxoSmithKline (GSK) on February 9, 2010 and GSK notified the FDA on March 15, 2010, which prompted the FDA’s action on March 22, 2010 to suspend use of Rotarix. The FDA says it “does not know how DNA from PCV1 came to be present in Rotarix” or whether “this means that intact virus is present. Additional studies are being conducted.” 6
Rotavirus Vaccines Use Monkey, Cow, Pig Materials for Production
Rotarix is a genetically engineered vaccine that GSK created by isolating human rotavirus strain infecting a child in Cincinnati and using African Green monkey kidney cells to produce the original viral seed stock from which all Rotarix vaccine has been made. 7 In the FDA licensing process, Rotarix had to meet certain FDA standards, that included demonstrating the vaccine was not contaminated with, for example TSE(Transmissable Spongiform Encephalopathy or “mad cow” disease, a brain wasting disease) 8 or with cow viruses because bovine (cow) serum was used to prepare the original viral seed stock. Porcine trypsin, an enzyme in the pancreatic juice of a pig, was also used to make the viral seed stock. 9
RotaTeq is a genetically engineered vaccine containing five human-cow reassortment strains of rotavirus that were created at the Children’s Hospital of Pennsylvania (CHOP), where strains of rotavirus that give cows diarrhea were combined with strains of rotavirus that cause diarrhea in humans. The reassortment viruses were transported to Merck, where master seeds were produced using African Green Monkey kidney cell cultures. Fetal bovine (cow) serum and porcine trypsin was used to make the “seed” stock. 10 There are small amounts of bovine serum and cell culture media (monkey viral DNA) that remain in RotaTeq vaccine. 11 12
FDA Suggests Drug Companies Test for Vaccine “Purity”
In a February 2010 FDA document, Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, the FDA lists “non-binding recommendations” for drug companies making vaccines using animal and human cell substrates. 13 Under the heading “Testing for Adventitious Agents,” the FDA states “assurance that products are free of adventitious agents is a critical component of meeting the [FDA regulations] requirement for purity.” Under the heading “Testing for Residual Cellular DNA,” the FDA states, “Residual DNA might be a risk to your final product because of oncogenic (cancer causing) and/or infectivity potential.”
Déjà Vu: Monkey Viruses Contaminated Polio Vaccines
Contamination of vaccines with animal viruses is not new. In the 20th century, polio vaccines given to tens of millions of people worldwide were contaminated with simian virus 40 (SV40), which was found to cause cancer in animals and is associated with human brain, bone and lung cancers but the government denies SV40 is causing those cancers in humans. 14 15 16 17
There has been controversy about the link between experimental polio vaccines tested in Africa in the 1950’s and 1960’s that were contaminated with a monkey virus, simian immunodeficiency virus (SIV). Soon after the polio vaccine trials in Africa, the human immunodeficiency virus (HIV) emerged. 18 Many questions about the failure of researchers and technology to screen for monkey viruses in those vaccines remain to this day.
Using Cancer Cells to Produce Vaccines?
Vaccine manufacturers have long used cell material that comes from the bodies of mammals, including humans, monkeys, cows, pigs, dogs and rodents, as well as birds or insects to make vaccines now in use or to make experimental vaccines. There is an inherent risk of contamination with viruses and other microbes (or DNA from those microbes) that can escape detection during the vaccine development, testing, licensing, manufacturing and oversight process. 19 There has even been discussion among vaccine manufacturers and the FDA in the last decade about using neoplastic (cancer)cell substrates to make vaccines but the risk of contamination with cancer cell DNA is a big risk. 20
New Influenza Vaccines: Is Contamination Possible?
In searching for ways to make seasonal influenza vaccines in a faster, easier and less expensive way than relying on chicken eggs for production, drug companies have experimented with using dog kidney cells and human fetal retinal cells. However, these cell lines have been documented to cause tumors in animals, especially dog kidney cells (MDCK). 21
At a November 19, 2009 meeting of the FDA Vaccines & Related Biological Products Advisory Committee, a vaccine manufacturer asked for permission to use insect (caterpillar) cells to make pandemic influenza shots. But insect cells can be contaminated with insect viruses that are hard to detect. The FDA Committee, on that day, voted “no.” 22
Unanswered Questions about Rotarix Contamination
There are lots of questions about how the manufacturer of Rotarix vaccine and the FDA both missed the pig virus DNA contaminating the original seed stock and all doses of Rotarix vaccine given to more than one million American children in the past few years. 23
Is there state-of-the-art technology that is being used by private laboratories but not by drug companies and the FDA?
Why did the independent team of scientists, who found the contamination, notify the vaccine manufacturer first rather than also immediately reporting their finding directly to the FDA?
What about the significance of finding bird viral DNA in measles vaccine and the monkey viral DNA in RotaTeq vaccine?
Wake Up Call for Industry & Government
The contamination of Rotarix vaccine is only the latest in a long history of vaccine contamination issues that require a re-examination of the way vaccines are made and tested. It is a wake-up call for industry and government
The big question people are asking is: why do drug companies making vaccines continue to use cells from animals, birds and insects that can be contaminated with viruses and other adventitious agents that are hard to detect?
The FDA was right to suspend use of Rotarix vaccine until they know more. Hopefully, this serious vaccine production and testing issue will be addressed immediately by vaccine manufacturers. If not, the next pandemic or serious health problem affecting large populations may be one that comes out of a vaccine lab.
SOURCE: NATIONAL VACCINE INFORMATION CENTRE
LINK TO SOURCE + VIDEO