The advent of cloned DNA vaccines & Synthetic Genomics, backed by proponents of the Trans-humanist & Bioethics movements (post-Darwinian view, in which the species has the power to direct its own evolution), has opened a Pandora’s Box spelling the inevitable death of natural immunity.
The field of vaccine research & development is currently undergoing a radical restructuring. The reasoning behind this sudden Industry paradigm shift and rapid evolution of modern medical techniques, including its relentless drive toward a global ‘ herd immunization’ policy, hinges on the effectiveness of new generation vaccines to combat increasingly virulent viruses, bacterium & infectious diseases. In turn, society’s compliance with any widespread immunization policy is more critical to the equation than ever.
Modern medicine brings with it claims of milestone “medical breakthroughs” in vaccine technology, the eradicating or limiting of life-threatening diseases & pandemics, enhancing our quality of life etc.
However on closer inspection the Industry itself admits to serious problems in confronting the basic laws of nature; the presence of “adventitious agents” (mutability factor/cross-contamination) when harnessing virus-heavy metal-tissue culture reagent-stabilizer cocktails in conjunction with animal cell substrates for vaccines.
‘Production of viral vaccines generally involves inoculation of a cell substrate (surface area/casing of cell) with a vaccine seed and purification of bulk product from these cells after a sufficient time for replication of the virus or production of vaccine proteins. Other raw materials (e.g., tissue culture reagents, stabilizers) may be added to the product at various stages of production. Thus, adventitious agents could theoretically enter a viral vaccine through any of these ingredients. Close control of the vaccine manufacturing environment (by producing vaccines in sophisticated modern facilities), appropriate testing of the raw materials, and testing of both the bulk and final products can help ensure that adventitious agents have not entered the vaccine.
“Many novel vaccines are produced in animal cell substrates, and emerging infectious diseases may theoretically be transmitted from animals to humans through these vaccines. The challenge of identifying potential adventitious agents in vaccines closely parallels the challenge of identifying the agents causing particular emerging infectious diseases.’ CDC
‘The experience in the early 1960s with SV40 contamination of poliovirus and adenovirus vaccines and the continuing questions regarding whether SV40 could be responsible for some human neoplasms (types of cancer) underscore the importance of keeping viral vaccines free of adventitious agents. This is particularly important when there is a theoretical potential for contamination of a vaccine with viruses that might be associated with neoplasia (cancer).
It is unclear whether neoplastic cells have a greater or lower adventitious agent risk than other types of cells. Because they can be grown for long periods in tissue culture, there may be greater opportunities for any adventitious agents to be detected. Because neoplastic cells survive indefinitely, it is easier to qualify and bank cells that have passed all tests, especially as compared with primary cells (which are derived repeatedly from live tissue and must be re-qualified with each use). Moreover, many neoplastic cells can be grown in serum-free medium, potentially reducing the likelihood of contamination with bovine adventitious agents.
However, if their growth in tissue culture is not well controlled, there may exist additional opportunities for contamination of cells with a longer lifespan. In cases of neoplastic cells for which the transforming event is unknown, there is also a theoretical possibility that transformation occurred as a result of a previous viral infection. Because some mammalian tumors and some cells transformed by viruses contain infectious virus, cells transformed by an unknown mechanism have a theoretical risk of containing a transforming virus. Cells for which specific knowledge of the transforming event exists (and can be shown not to be a virus that persists in the cells) may be more easily characterized than cells for which there is no specific knowledge of the transforming event (which could theoretically have been due to an infection with a known or an unknown virus).
In addition to assessing the possibility of contamination of cell substrates with infectious virus, it is important to consider other agents such as the agent of TSE (Transmissible Spongiform Encephalopathy). There are several mechanisms by which vaccine cell substrates, including neoplastic cells, could theoretically become infected with a TSE agent.’ US Food & Drug Administration
The Influenza virus itself is constantly mutating from year to year. While mainstream doctors are traditionally divided, several prominent Studies have come forward in recent years challenging the Status Quo on the efficacy of the sacrosanct Flu shot & awakened an increasingly distrustful public to the ineffectiveness and inherent danger of vaccines.
‘Over 200 viruses cause influenza and influenza-like illness which produce the same symptoms (fever, headache, aches and pains, cough and runny noses). Without laboratory tests, doctors cannot tell the two illnesses apart. Both last for days and rarely lead to death or serious illness. At best, vaccines might be effective against only influenza A and B, which represent about 10% of all circulating viruses. Each year, the World Health Organization recommends which viral strains should be included in vaccinations for the forthcoming season. Influenza vaccines have a modest effect in reducing influenza symptoms and working days lost. There is no evidence that they affect complications, such as pneumonia, or transmission.’ The Cochrane Review
‘Children and the elderly are the two age groups that appear to have the most complications following an influenza infection. In children under the age of two, the efficacy of inactivated vaccine was similar to placebo. Very little info’ found on safety of inactivated vaccines in young children.‘ Cochrane Review
‘A “perplexing” Canadian study linking H1N1 to seasonal flu shots is throwing national influenza plans into disarray and testing public faith in gov’t agencies responsible for protecting the nation’s health. Study confounds infectious-disease experts in suggesting that people vaccinated against seasonal flu are twice as likely to catch swine flu. “It has confused things very badly,” said Dr. Ethan Rubinstein, head of adult infectious diseases at the University of Manitoba. “And it has certainly cost us credibility from the public because of conflicting recommendations. Until last week, there had always been much encouragement to get the seasonal flu vaccine.‘ Globe & Mail
‘Association between the 2008–09 Seasonal Influenza Vaccine and Pandemic H1N1 Illness during Spring–Summer 2009: Four Observational Studies from Canada: ‘Estimates from the sentinel and three other observational studies, involving a total of 1,226 laboratory-confirmed pH1N1 cases and 1,505 controls, indicated that prior receipt of 2008–09 TIV (trivalent inactivated influenza vaccine aka regular flu shot) was associated with increased risk of medically attended pH1N1 illness during spring–summer 2009.‘ British Columbia Centre for Disease Control
Vaccine Manufacturers & National Health Departments have begun universally emphasizing the need for alternative methods of product development; transitioning to more radical cloned cell-based technology (‘laboratory-grown cell lines that are capable of hosting a growing virus’) – already in Phase 3 Clinical Stages pre-production. Reasons sighted include the Flu vaccine itself which incurs the most demand year to year. Egg based vaccine production is deemed inefficient, both “time-consuming and resource-constrained”, not only below “capacity” but readily “perishable”.
‘In order to produce 300 million doses of vaccine, egg-based production would require some 900 million eggs. In the case of an avian flu pandemic, egg-producing flocks could decline, jeopardizing vaccine production capabilities.While eggs are perishable, cell lines can be safely kept frozen indefinitely, increasing the capability to rapidly produce vaccines if an influenza pandemic were to occur. Vaccine manufacturers are able to bypass the steps needed to adapt the virus strains to grow in eggs. People allergic to eggs cannot receive vaccines produced from chicken eggs, but can be immunized with a cell-based vaccine.
The new approach would use mammalian cells (kidney cells are often used) to grow the influenza viruses. Cell-based vaccine production could more easily meet “surge capacity needs” because cells could be frozen and stored in advance of an epidemic or developed rapidly in response to an epidemic. Cell-based vaccine production dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods. In place of eggs, cell-based vaccine production utilizes laboratory-grown cell lines that are capable of hosting a growing virus. The virus is injected into the cells where it multiplies. The cells’ outer walls are removed, harvested, purified, and inactivated.’
Vaccine Cell Substrates are taken from Animal Primary & Diploid cells or via continuous cell lines -
1. Primary cells are obtained directly from the tissues of healthy animals. Primary cells are more likely to contain adventitious agents than banked, well-characterized cells. This concern with primary cells is mitigated by rigorous qualification of source animals and primary cell substrates. Animals from which primary cultures are established should be from specific-pathogen-free (SPF) closed flocks, herds, or colonies, when feasible. The term “closed” refers to the maintenance of a group (flock, herd, and colony) free from introduction of new animals (new genetic material). Animals that are not from closed flocks, herds, or colonies should be quarantined and thoroughly evaluated for a period sufficient to detect signs of disease or infection before introducing them into the flock, herd, or colony.
Note: ‘Primary cells are more likely to contain adventitious agents…’.
2. Diploid cell strains (derived from aborted fetal tissue) are established from primary cell cultures by expansion and cell banking. These types of cells have a finite life span and are not immortal like cell lines. Diploid cells usually retain a diploid or near diploid karyotype, a characteristic that also differs from cell lines, which are generally aneuploid or non-diploid.
Note: ”Human Diploid Cells are associated with an increased risk of a theoretical ‘oncogenic agent’ (an agent that causes neoplasms/cancer)’.
3. Some continuous cell lines, including Vero cells (derived from African Green Monkey kidneys – patent owned by ‘Dyncorp’) and CHO cells (derived from Chinese hamster ovaries), have been used as substrates for licensed biologicals. Cell lines might have biochemical, biological, and genetic characteristics that differ from primary or diploid cells (e.g., they are typically aneuploid and have accumulated genetic changes). Because the mechanism by which most cell lines become immortal is generally unknown, and because some cell lines form tumors when inoculated into immunodeficient rodents, there are additional concerns for continuous cell lines compared with diploid cells, including the potential that transformation was caused by an adventitious agent and potential risks from residual DNA.
Note: ‘…there are additional concerns for continuous cell lines compared with diploid cells, including the potential that transformation was caused by an adventitious agent and potential risks from residual DNA’
‘Many live attenuated vaccines for animals are manufactured by using cell lines from animals, which are known to produce infectious ‘endogenous retroviruses‘ (Remnants of ancestral exogenous retroviral infections fixed in the germline DNA); however, the risks of infection by ERVs from xenospecies through vaccination have been ignored.’ Laboratory of Signal Transduction, Department of Cell Biology, Institute for Virus Research, Kyoto University
‘The human body retains a genetic memory of the foreign substances (endogenous retroviruses – remnants of ancestral exogenous retroviral infections fixed in the germline DNA) to which it has been exposed, including viral and bacterial vaccines…There appears to be a limit on how much foreign material to which the human body can be exposed before some level of genetic damage occurs and a chronic disease initiates.’ Testimony of Dr. Howard B. Urnovitz, August 3, 1999, Committee on Government Reform and Oversight/House of Representatives
‘With little incentive to invest in new manufacturing facilities or technologies, influenza vaccines historically were produced by a small number of manufacturers, all of whom have utilized a five decade-old, time-consuming and resource-constrained poultry egg–based technology. Every year, the WHO makes a recommendation regarding the three most likely strains for the coming flu season; the influenza vaccine manufacturers inject a mix of those strains in chicken eggs exactly 11 days after they’ve been fertilized; the eggs incubate for several more days, then the resulting virus is purified, inactivated and used to produce the vaccine. Although it is cost-effective, this production strategy is time-, labor- and material-intensive. Moreover, there is only a limited supply of 11-day-old fertilized poultry eggs at any given time, reducing the industry’s ability to respond rapidly to a sudden need for new vaccines.’ Quintiles White Papers
‘Flu vaccines have to be made fresh every year to match the circulating strains of the virus. They are made using old technology involving chicken eggs, and manufacturers cannot always predict how much vaccine they will be able to produce and when. A few companies can now make vaccine in cells and governments are working with industry to switch over to faster and more predictable ways to make flu vaccines.’ Reuters
‘The White House on Thursday said the controversial field of synthetic biology, or manipulating the DNA of organisms to forge new life forms, poses limited risks and should be allowed to proceed. The Presidential Commission for the Study of Bioethical Issues (Eugenics) “concluded that synthetic biology is capable of significant but limited achievements posing limited risks,” it said in its first report. Critics said the discovery was tantamount to “playing God,” creating organisms without adequate understanding of ramifications, upsetting the natural order.’ But the commission said Venter’s team had not actually created life, since the work mainly involved altering an already existing life form.‘ AFP
It should come as no surprise that the flagship model, the first major Cloned cell-based vaccine ever for mass production, FLUVIRIN®, manufactured by Novartis Vaccines, will be introduced in the Fall of 2011 in the United States with the annual Flu shot; touted as a ‘Recombinant Trivalent Hemagglutinin Protein-based Influenza Vaccine’. No matter which route you take in terms of the application of 21st century vaccine production technology (cloning), all roads will inevitably lead to (otherwise avoidable) cancer.
Novartis’ vaccine facility in Holly Springs, North Carolina today became the first cell culture vaccine facility authorized by the U.S. Food and Drug Administration for emergency use during a pandemic. The plant will develop vaccines from cultured animal cells, in contrast to the traditional method of making flu vaccines from chicken eggs…The Novartis site is designed to provide 150 million adjuvanted doses of pandemic influenza vaccine within six months of declaration of an influenza pandemic. In the event of an influenza pandemic, the new Novartis facility could produce up to 25 percent of the vaccine needed in the United States.
The cell-based technology employed by the plant could also be adapted to produce vaccines for other infectious diseases in an emergency. The new Holly Springs plant came about in partnership with the federal government. Novartis and HHS collaboration committed $1 billion to the facility, with federal funds coming from BARDA.’
‘First U.S. cell-based flu vaccine plant set for dedication: The facility is a public-private partnership of the U.S. Department of Health and Human Services, and Novartis Vaccines and Diagnostics, Inc. of Cambridge, Mass. This partnership will be maintained under contract for at least 25 years…In addition to partnering to bring cell-based flu vaccine and adjuvant technologies to the United States, HHS and Novartis are partnering with Synthetic Genomics Vaccines of Rockville, Maryland on new technologies to shorten the vaccine manufacturing timeline by optimizing vaccine virus seed strains used for flu vaccine production…BARDA and Novartis also are working with North Carolina State University to train scientists from other countries to use cell culture based manufacturing techniques similar to what is used in the new facility. The training program is part of a World Health Organization initiative to strengthen the ability of developing countries to produce flu vaccine, potentially reducing the global threat from influenza.’
An earlier cell based prototype (pre cloned cell), ‘Optaflu’, also manufactured by Novartis, was approved for use in the EU in April of 2007. “Novartis Vaccines is pleased with this positive recommendation for Optaflu, the first cell culture-derived influenza vaccine and the first major innovation in influenza vaccine manufacturing in more than 50 years,” said Dr. Jörg Reinhardt, CEO of Novartis Vaccines and Diagnostics.
“Optaflu contributes to meeting the growing demand for seasonal influenza vaccines, and this production technology offers the potential for quick scale-up of manufacturing in the event of an influenza pandemic.”
‘Optaflu, the Novartis vaccine, was first supplied as a seasonal flu vaccine in January 2008, following its European approval in 2007, according to a company statement provided by spokeswoman Sarah Coles. From 2009 onward, “the process was dedicated to pandemic vaccine production” for the 2009 H1N1 vaccine, the company said. Regarding production volume so far, “Novartis produced a number of seasonal doses and over 25 million doses of cell-based pandemic vaccine for the 2009 H1N1 pandemic, demonstrating a rapid response to the global health threat,” the statement said.’
‘Novartis’ EU-approved flu shot, Optaflu, was produced using a cell line called Madin-Darby (MDCK), cells extracted from the kidneys of a female cocker spaniel. Dutch giant, Solvay Pharmaceuticals, has been working with MDCK cells since the early 1990s.’
Optaflu: package insert -
3 strains of ‘inactivated’ Influenza virus surface antigens (haemagglutinin and neuraminidase) propagated in Madin Darby Canine Kidney (MDCK) cells.
List of excipients: Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Disodium phosphate dihydrate, Potassium dihydrogen phosphate.
Optaflu is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy.
The safety of Optaflu in pregnancy and breast-feeding has not been assessed in pre-clinical studies or in clinical trials.
Novartis recently joined forces with the world’s leading genomic driven technologies company, Synthetic Genomics Inc, in applying ‘”synthetic genomics” technologies to accelerate the production of the influenza seed strains required for vaccine manufacturing’, allowing them the ability to harness designer cells for rapid factory production of vaccines.
According to SGI, synthetic genomics permits the construction of any specified DNA sequence, enabling the synthesis of genes (units of an organism’s hereditary information) or entire genomes (the entirety of an organism’s hereditary information), a process involving synthesis of ‘a 1.08 million base pair Mycoplasma mycoides genome, constructed from four bottles of chemicals that make up DNA. This synthetic genome has been “booted up” in a cell to create the first cell controlled completely by a synthetic genome.’
The three-year agreement, supported by an award from the U.S. Biomedical Advanced Research and Development Authority (BARDA), could ultimately lead to a more effective response to seasonal and pandemic flu outbreaks.’ The floodgates have finally opened, and with that the potential for disaster.
Barda is leveraging its options in this highly lucrative “marketplace“, by simultaneously finacing the competition. One such manufacturer entering the arena, Protein Sciences Corporation (PSC), with the help of a $147 million joint contribution (‘awarded a contract in June 2009 to support further development and scale-up of our flu vaccines, FluBlok and PanBlok’), have launched a major campain to unseat Novartis, with their very own misguided cloning-type patent for vaccine production, involing the replication of “transgenic insect cells” for use in vaccine production. ‘We have established a broad patent estate on influenza vaccines produced using recombinant technology in our expresSF+ cells.‘
‘ExpresSF+ Cells: We have created and patented a unique Spodoptera frugiperda insect cell line, expresSF+ cells, to optimize protein production using our BEVS technology. These cells have been extensively characterized and products manufactured from them have received regulatory clearance for human clinical testing in the United States, Japan, Australia, Europe, Canada and elsewhere…We have developed and patented a Baculovirus Expression Vector System (BEVS) that we use in all of our products and services. This platform leverages the natural infection process of insect cells by baculoviruses. We re-engineer the baculovirus such that it programs the infected insect cells to generate large quantities of desired recombinant protein(s). Our proprietary expresSF+ cell line has been optimized for this purpose. The end result is the production of large amounts of pure protein, generated more quickly and less expensively than other production systems.‘ Protein Sciences Corporation
ExpresSF+ Cells Patent ‘Baculovirus-based vectors have been generated (or can be generated without undue experimentation) that allow the cloning of large numbers of inserts, at any of a variety of cloning sites in the viral vector. Thus, more than one heterologous polypeptide may be introduced together into a transgenic insect cell or insect of the invention. The viral vector can be introduced into an insect cell or insect by conventional methods, such as by in vitro inoculation (insect cells) or oral ingestion (insect larvae).’
‘Protein Sciences Corporation (“Protein Sciences”) announced today that it has granted Merck, through a subsidiary, a non-exclusive license to Protein Sciences’ proprietary expresSF+® serum-free insect cell line (SF+) and related technology (collectively, PS Technology) to conduct vaccine research. In addition, Protein Sciences has granted Merck an exclusive license to use PS Technology for commercial production of an undisclosed vaccine candidate.’ 02/22/12
Studies have proven that consumption of genetically altered/modified organisms (GMO) is associated with infertility, excessive cancer cell growth, organ lesions, altered liver & pancreas cells, changes to enzyme levels, Immune system failure and anti-biotic resistance in animals. Nature has responded to man’s attempts at reshuffling the deck by literally re-assorting man. J. Craig Venter, founder of Synthetic Genomics (SGI), who created the first synthetic bacterial cell, is now seeking, among other conceits “the synthesis not just of viruses but of whole bacteria, which have much larger genomes”, to “design and construct from scratch bacterial genomes as well as simple chromosomes of eukaryotic cells (those containing a cell nucleus), such as yeast. Since the sequence is generated by chemical synthesis, there is full choice in the subsequent manipulation of the sequence information. This ability is the essence of the chemical approach to the study of biological specificity in DNA/RNA.”
“The ability to routinely write the software of life”, a calling card of Venter and other so called “visionaries”, indicates a hubris & fundamental disregard for nature; and a gross miscalculation of nature’s retaliatory instinct. We have entered “the golden era of vaccines“, and nothing will stop this speeding train. Assembly has begun on a process termed ‘Cell proliferation’. Novartis have even secured their own official “proprietary cells” to ‘grow in suspension…do not require attachment to a surface to proliferate. During production, one ampule of stored cells is thawed and expanded in several steps. At each stage the cells are placed in fermenters (stainless steel tanks) that provide the optimal environment for growth including the proper temperature, pH value and nutrient solution. The proliferation of the cells is constantly monitored. Cell proliferation takes place in a contained fermenter system within so-called clean rooms.’
Even prominent spokesmen in the Industry such as Dr. Antony Fauci, director of the National Institute of Allergy & Infectious Diseases (co-patent holder of “IImmunologic enhancement with intermittent interleukin-2 therapy” described as being central to gene therapies and the future of “geneto-pharmaceuticals”) must acquiesce, “Because the influenza virus genome is segmented, coinfection of a single host cell with two or more different influenza viruses can result in a reassortment (shuffling) of their genetic material. The antigenic shift can lead to a pandemic if the resulting progeny virus contains an HA protein to which humans have no preexisting immunity, if it has an efficient replication-competent set of internal genes, and if it can readily spread from human to human.” This is the fundamental problem inherent to all vaccines - a game of genetic roulette.
In a competitive maneuver to distance itself from the competition SGI are gaining a foothold on Patent rights in what is sure to be a footrace to the top; while seeking to establish a criteria of regulations in a highly unpredictable arena. They have also, inadvertently, exposed the Achilles Heel of genetic research – the unlimited potential for misuse of such critical knowledge. It may turn out we have more to fear from our Gov’t, in this respect, than from some random act of so called “terrorism”.
‘Today, using machines called DNA synthesizers, the individual subunit bases adenine (A), cytosine (C), guanine (G), and thymine (T) can be assembled to form the genetic material DNA in any specified sequence, in lengths of tens of thousands of nucleotide base-pairsiii using readily accessible reagents. Precisely how a scientist or engineer will obtain the pieces of DNA of interest will vary depending on the resources and preferences of that individual.
The ability to carry out DNA synthesis is no longer confined to an elite group of scientists as was the case for the first several decades of research using recombinant DNA. Now, anyone with a laptop computer can access public DNA sequence databases via the Internet, access free DNA design software, and place an order for synthesized DNA for delivery.’ Synthetic Genomics: Options for Governance, Michele S. Garfinkel, The J. Craig Venter Institute
‘The alternative approach that concerns us here is that someone could synthesize the entire genome of a dangerous pathogen, such as smallpox, from scratch. This requires no access to the secure laboratories. Potentially it requires no prior experience in working with the pathogen. Most troubling is the fact that such synthesis could be accomplished in a conventional molecular biology laboratory, without the need for specialized equipment and without attracting attention to the project from others. The technology required to synthesize the genome of an entire viral pathogen, or genes thereof, is already available. Rapid development in the field of synthetic biology is destined to make this process easier, faster and cheaper.
The turnaround time for the synthesis of a gene of a few thousand nucleotides is a couple of weeks and the cost can be as low as $1.60 per nucleotide. At this price point it becomes easier to synthesize certain genes than to try to isolate them from their native genomes. There are around 25 companies in the US that offer this service with about the same number in the rest of the world, mostly in Europe. However, it would appear that most of that work is performed in a small subset of these companies.’ Synthetic Genomics: Risks and Benefits for Science and Society
‘The rapidly advancing technology of whole genome assembly (“synthetic genomics”) is making the chemical synthesis of viral genomes (DNA copy of a pathogenic virus genome) a much less tedious endeavor. Synthetic technology is capable of preparing a DNA copy of any virus for which its nucleotide sequence (template of an organism’s nucleic acid – basic building blocks of life) is known.
There are three DNA virus families, comprising the threat agents African swine fever virus (Asfarviridae), herpes B virus (Herpersviridae) and a number of poxviruses including smallpox virus (Poxviridae). These viruses have large double-stranded DNA genomes (150-205 kilobase pairs, kbp) and encode on the order of 100 gene products that are essential for virus replication, as well as another 100 “nonessential” gene products, many of which are involved in the modulation of host responses to virus infection and viral pathogenesis.
All remaining threat viruses, derived from 13 distinct virus families, are RNA viruses with genomes of positive (messenger) RNA sense (6 families), negative RNA sense (6 families) or double-stranded RNA (1 family). RNA virus genomes range in length from about 8 kb (Picornaviridae) to about 30 kb (Coronaviridae). Generally, most or all of the gene products encoded by RNA viruses are essential for virus replication. Some are also involved in the modulation of host responses to virus infection and viral pathogenesis.
When passaged in the laboratory (in either cell culture or lab animals), primary isolates often become attenuated. The attenuation is the result of adaptive genetic changes that the virus acquires in order to survive in its new environment. These genetic changes can be subtle (single nucleotide changes) or dramatic (genome deletions or rearrangements). Generally, the longer a virus is propagated in cell culture, or through non-natural animal hosts, the greater the attenuation. In fact, this is the basic methodology for the development of many live attenuated virus vaccines.
…the degree of attenuation of laboratory-passaged viruses may or may not be known. There can in some cases be uncertainty regarding the biological attributes of a synthetic replica of a gene bank virus sequence.
All viruses listed exist in numerous laboratories throughout the World, including academic research labs, diagnostic, hospital and nation state health labs, as well as in biologics repositories (collectively, “laboratories”). For smallpox virus, the only known stocks remain in two high security laboratories. For all the other viruses, many research laboratories around the world have studied, and continue to study their structure, biology, molecular biology, genetics, immunology, pathogenesis and epidemiology.
African swine virus and poxvirus genomic DNAs are not infectious because of the requirement for activities of viral enzymes packaged within the virion. This requirement can be fulfilled for poxviruses, for example, by transfecting the viral genomic DNA into cells previously infected with another poxvirus. The resident “helper” virus provides the trans-acting systems needed to activate the transfected DNA and yield fully competent infectious virus.
For the (+)ssRNA viruses, simply transfecting a DNA copy of the mRNA-sense genome into cells generally yields infectious virus.
For (–)ssRNA viruses, infectious virus can be recovered from cDNA designed with transcriptional promoters to yield full-length anti-genomic RNA upon transfection, either alone or together with plasmids encoding the expression of various viral proteins, into cells that provide the appropriate RNA polymerase. For segmented genomes, simultaneous transfection of multiple anti-genome plasmids is involved.
For the one dsRNA virus (Reoviridae), the system for the recovery of infectious virus directly from DNA has not been described. However, a reverse genetics system that involves the lipofection of cells with plus strand RNA transcripts or dsRNAs representing the 10 genomic segment of reovirus, together with a rabbit reticulocyte lysate in which ssRNA or melted dsRNA has been translated, can yield infectious virus after provision of a helper virus.
Because of this high level of population susceptibility, smallpox (variola) virus is often considered the number one bioterrorism threat virus. Transmission of variola virus generally requires close contact with an infected individual. While this makes it possible to effectively interrupt chains of transmission by quarantine and restrictive movement methods, the average number of cases infected by a primary case is estimated at 3.5 to 6, indicating that an outbreak would produce a rapid rise in cases before control measures could be put in place. In addition to the significant morbidity associated with infection, death occurs in up to 30% of cases.
While nature has provided would-be bioterrorists an ample supply and selection of quite virulent viruses (Table 1), there is concern that genetic technologies will be used to modify these already pathogenic agents and create “super-pathogens”, viruses that are more lethal and disruptive than naturally occurring pathogens, and that are designed to evade vaccines or to be resistant to drugs.
There may be a number of ways to augment a viral bioweapon. Virus infectivity, virulence or transmissibility might be enhanced by, for example:
• Increasing the replicative capacity of the virus by modifying the viral polymerase or gene expression by optimizing for human codon usage,
• Changing the tropism of the virus by incorporating genes encoding particular cellular receptor binding proteins,
• Engineering drug-resistance determinants into the virus (should there exist antiviral drugs for the virus), or
• Compromising or overwhelming the host immune response to infection or vaccine-induced immunity by incorporating into the virus genes encoding human immune system antagonists.
Additionally, random approaches, such as DNA shuffling (accelerated or directed molecular evolution) or combining genetic elements of distinct pathogenic viruses to create chimeric viruses, could be applied to bioweapons enhancement.’ Impact of Synthetic Genomics on the Threat of Bioterrorism with Viral Agents, Marc S. Collett/ViroDefense Inc.
Aside from the upcoming Recombinant Trivalent Hemagglutinin Protein-based Influenza Vaccine, a host of other cloned cell based vaccines are now being readied for circulation:
1. Live virus-type Influenza vaccine: ‘Efforts also are under way to develop live influenza vaccines based on the influenza NS1 protein, a nonstructural, multifunctional protein involved in viral replication and inhibition of the host’s innate immune responses.”
2. Virus-like particle vaccine: ‘Recombinant viral vectors that express HA, NA, and the influenza matrix (M1) protein — a structural protein lining the inside of the viral envelope that is involved in viral assembly and budding — are used to infect cultured cells. The expressed influenza proteins spontaneously self-assemble at the plasma membrane and bud from the infected cells, forming particles that structurally resemble wild-type viruses. Other influenza proteins or immune-enhancing molecules can be incorporated into the budding particle.’
3. Viral vector vaccine: ‘Influenza HA genes from seasonal or H5N1 viruses, or both, have been cloned into so-called carrier viruses, including vaccinia virus, alphaviruses, adenoviruses, Newcastle disease virus, baculoviruses, and vesicular stomatitis virus. Cellular and antibody responses that provide protection against the vaccine virus and antigenically drifted strains have been shown to develop in animals vaccinated with these viral vectors.’
4. DNA-based vaccine: ‘Encoding the HA or NA protein, injected intramuscularly either alone or in combination with internal gene segments in animals.’
5. Universal vaccine: ‘The ideal influenza vaccine would be one that is safe, elicits humoral and cellular responses identical to those triggered by a natural infection, provides long-lasting and cross-strain protection, and can be manufactured rapidly in large amounts under well-controlled conditions. Major targets in the search for a “universal,” or “common-epitope,” vaccine have been the highly conserved external domain of the influenza matrix 2 (M2) protein and conserved epitopes from the influenza NP, matrix 1 (M1), and HA proteins..’
Next-Generation Infectious Disease Vaccines: Novel Technologies and Opportunities – ‘Innovative vaccine technologies: virus-like particles, baculovirus/insect cell expression systems, DNA vaccines, recombinant viral vectors, universal vaccines, synthetic genome technology. Emerging alternative delivery systems: transdermal vaccine patches, electroporation, nanoparticle technology.’ http://www.nejm.org/doi/full/10.1056/NEJMra1002842
SGI have also cornered the market on alternative bio-fuel with their brand of “synthetic algae”; through an unlikely partnership with ExxonMobil (the largest natural gas producer in the US). ‘Synthetic Genomics Inc. (SGI), a privately held company applying genomic-driven commercial solutions to address a variety of global challenges including energy and the environment, announced today a multi-year research and development agreement with ExxonMobil Research and Engineering Company.’
They have begun research & testing on a form of “synthetic algae” for widespread harvesting, backed by a staggering $600 million of investment.
‘Photosynthetic algae, which include microalgae (single celled algae) and cyanobacteria (most commonly known as blue-green algae) are organisms that are very efficient at utilizing the energy from sunlight to convert carbon dioxide into cellular oils (lipids) and even some types of long-chain hydrocarbons that can be further processed into fuels and chemicals. However, naturally-occurring algae do not carry out this process at the efficiencies or rates necessary for commercial-scale production of biofuels.
Using SGI’s scientific expertise and proprietary tools and technologies in genomics, metagenomics, synthetic genomics, and genome engineering as a platform, SGI and EMRE believe that biology can now be harnessed to produce sufficient quantities of biofuels.’
SGI’s synthetic algae is now being put to use on several fronts: as an alternative fuel hybrid in the US Navy ($435/Gallon), for ‘microbial enhanced hydrocarbon recovery and conversion solutions for the production of fuels and chemicals from these vast reserves’.and as a “Methane-munching bacteria” (Project titled ‘Synthia‘), added to Core Exit, to tackle the Deepwater Horizon blowout in the Gulf of Mexico. There is speculation that synthetic algae may be the cause of many abnormal occurrences that have plagued the local communities; including a recurring flesh eating skin rash, widespread fish & bird deaths, high concentrations of methane gas, exploding glass, odd smelling shrimp.
This has grave implications, not only for the environment on which we depend, but ultimately towards maintaining the viability of our natural immunity; the capacity to withstand & adapt to genetic manipulation. If the disruption of natural life in the Gulf is any indication, the odds are not in our favor.
BP Oil Spill Scientist Bob Naman: Seafood Still Not Safe
Thousands of Gulf Oil Spill clean-up crew are dying
The vanguard in the field of vaccine research claim “Cell-based vaccine production dramatically reduces the possibility for contamination”. Let us review some of the noteworthy findings of National Health Regulators & Medical Practitioners/Researchers thus far:
1. ‘Because the influenza virus genome is segmented, coinfection of a single host cell with two or more different influenza viruses can result in a reassortment (or shuffle) of their genetic material.’
2. ‘Because neoplastic (cancerous) cells survive indefinitely, it is easier to qualify and bank cells that have passed all tests, especially as compared with primary cells (which are derived repeatedly from live tissue and must be re-qualified with each use).’ NOTE: Optaflu, early cell based Novartis prototype vaccine, was produced using a cell line called Madin-Darby (MDCK), cells extracted from the kidneys of a female cocker spaniel.
3. ‘Adventitious agents (mutable viruses/cross-contamination) could theoretically enter a viral vaccine through any of these ingredients (cell substrates, vaccine seed, tissue culture reagents, stabilizers).’
5. ‘It is unclear whether neoplastic cells have a greater or lower adventitious agent risk than other types of cells. Because they can be grown for long periods in tissue culture, there may be greater opportunities for any adventitious agents to be detected.’
6. ‘If their growth in tissue culture is not well controlled, there may exist additional opportunities for contamination of cells with a longer lifespan. In cases of neoplastic cells for which the transforming event is unknown, there is also a theoretical possibility that transformation occurred as a result of a previous viral infection.’
7. ‘Because some mammalian tumors and some cells transformed by viruses contain infectious virus, cells transformed by an unknown mechanism have a theoretical risk of containing a transforming virus.’
8. ‘The human body retains a genetic memory of the foreign substances (endogenous retroviruses – remnants of ancestral exogenous retroviral infections fixed in the germline DNA) to which it has been exposed, including viral and bacterial vaccines…There appears to be a limit on how much foreign material to which the human body can be exposed before some level of genetic damage occurs and a chronic disease initiates.‘ Testimony of Dr. Howard B. Urnovitz, August 3, 1999, Committee on Government Reform and Oversight/House of Representatives
9. ‘Over 200 viruses cause influenza and influenza-like illness which produce the same symptoms (fever, headache, aches and pains, cough and runny noses). At best, vaccines might be effective against only influenza A and B, which represent about 10% of all circulating viruses.’
10. ‘A “perplexing” Canadian study linking H1N1 to seasonal flu shots is throwing national influenza plans into disarray and testing public faith in gov’t agencies responsible for protecting the nation’s health. Study confounds infectious-disease experts in suggesting that people vaccinated against seasonal flu are twice as likely to catch swine flu.’
11. ‘There is concern that genetic technologies will be used to modify these already pathogenic agents and create “super-pathogens”. DNA shuffling (accelerated or directed molecular evolution) or combining genetic elements of distinct pathogenic viruses to create chimeric viruses, could be applied to bio-weapons enhancement.’
12. ‘Xenotropic murine leukemia (cancer) virus-related virus (XMRV) is a recently discovered human (endogenous, cloned) retrovirus that has been found in both chronic fatigue syndrome (Fibromyalgia) & prostate cancer patients. Although these findings need further confirmation, there is a potential safety concern regarding XMRV in cell substrates used in vaccines and in transmission by blood transfusion and blood products.’ FDA
Note: Consumption of genetically altered/modified organisms (GMO) is associated with infertility, excessive cancer cell growth, organ lesions, altered liver & pancreas cells, changes to enzyme levels, Immune system failure and anti-biotic resistance in animals.
NEW DIRECTIONS: The Ethics of Synthetic Biology and Emerging Technologies/Presidential Commission for the Study of Bioethical Issues, Washington, D.C., December 2010
‘Proponents of synthetic biology cite its potential to reduce our reliance on fossil fuels and transform medical care and human health, among other possible benefits. Critics express concerns about “playing God,” threatening biodiversity and the organization and natural history of species, demeaning and disrespecting the meaning of life, and threatening longstanding concepts of nature.
First, sheer prudence suggests that we as a society must respect the intricacies of the natural world. Biological systems have developed over billions of years, and their interactions with the environment are astoundingly complex. We are far from being proficient speakers of the language of life, and our capacity to control synthetic organisms that we design and release into the world is promising but unproven.
Second, understanding our own limitations is an essential prelude to minimizing the risks that will accompany ongoing breakthroughs in synthetic biology and related fields. like other new technologies, synthetic biology poses uncertain risks. Rapidity of change, both in the field of biology and in the public’s understanding of it, as well as accelerating information exchange and technological competence heighten these concerns. Today, predicting cell function from gene sequence alone is very difficult and often impossible.
While the successful synthesis of a functional bacterial chromosome is an essential technological step for the development of synthetic biology, it represents a preliminary advance. We remain far from having the scientific and technical expertise required to create truly novel functioning organisms. We must be cognizant, however, of our limited current understanding of what synthetic biology and related technologies may produce in the future and be willing to reassess benefits and harms as the field develops.
Third, ancillary effects and challenges should be recognized and considered. The rise of an economy based on biotechnology may expand jobs and lead to significant financial benefits, but it could also result in economic displacement, excessive demands on already scarce resources, and increased social and economic stratification. Anticipating all of the ramifications of our actions is impossible, but determining how to respond to this uncertainty is the better part of wisdom.
Among living beings, humans are in a unique position to be responsible stewards of nature, the earth’s bounty, and the world’s safety. human society and governments have a duty to proceed prudently in promoting science and technologies, many of which can improve human welfare but also can harm the environment, create security risks, or otherwise lead to adverse consequences for vulnerable populations or future generations.
The principle of responsible stewardship reflects a shared obligation among members of the domestic and global communities to act in ways that demonstrate concern for those who are not in a position to represent themselves (e.g., children and future generations) and for the environment in which future generations will flourish or suffer. Scientists, policy makers, and the public are tasked with appreciating that the tools of science and technology possess both remarkable potential to enhance future lives and a spectrum of risks capable of causing harm. Both demand attention and action.
Responsible stewardship recognizes the importance of citizens and their representatives thinking and acting collectively for the betterment of all, especially those who cannot represent themselves. These activities must respect the significant impact—both positive and negative—that our decisions have on our world, both today and in the future.
Benefits and risks extend to humans, nonhuman species, and the environment, each with unique needs and vulnerabilities. Emerging technologies present particularly profound challenges for responsible stewardship because our understanding of these potential benefits and risks is largely incomplete,preliminary, and uncertain. The prospect of intentional misuse by malicious actors further complicates efforts to respond adequately to the spectrum of benefits and risks.
Note: ‘..our capacity to control synthetic organisms that we design and release into the world (the essence of Trans-humanism) is promising but unproven.’
Synthetic Biology is the cornerstone of the Globalist control mechanism to gain complete dictatorial control over society, the scientific means by which these select Elites intend to re-engineer the entire human species and establish their distopian empire, a Technotronic, Trans-humanist Police State where-in the masses are completely beholden to a ruthless eugenics directive, involving genetic roulette. This will inevitably spell the end of natural immunity, and ultimately the death of humanity as we know it. The road they are paving for us leads to one penultimate end…cancer.
‘This might involve the metabolic engineering of microbes to produce useful products such as biofuels (or their precursors) or synthetic molecules tailored for therapeutic purposes. This would also include synthesizing a life form that consists only of a minimal number of functional elements by removing redundant or non-essential genetic material, or that employs a modified genetic code. This so-called “chassis organism” would contain a genome that might be more easily engineered.’
‘For “re-writers,” the designs of natural biological systems may not be optimized for human intentions (for example, scientific understanding, health, and medicine); synthetic biology provides an opportunity to test the hypothesis that the genomes encoding natural biological systems can be “re-written,” producing engineered surrogates that might usefully supplant some natural biological systems.’
‘In an approach referred to as “synthetic metagenomics,” automated chemical synthesis and computational optimization of genes from environmental metagenomic libraries have been used to create symbiotic consortia of engineered organisms that produce significant amounts of precursor molecules for important industrial chemicals and fuels. Plants and microbes also are being engineered for biological remediation applications that offer low-cost, environmentally friendly solutions to pollution and contamination.’ National Science Advisory Board For Biosecurity (NSABB): Addressing Biosecurity Concerns Related To Synthetic Biology
In a 2003 declassified CIA Report titled ‘The Darker Bioweapons Future‘ a panel of life science experts noted, “The same science that may cure some of of worst disease could also be used to create the world’s most frightening weapons.” This is precisely the path down which Venter & the entire Trans-humanist Movement (which strives to redesign the human condition, transcending our biological limitations by means of technology – closely aligned with Bioethics/Eugenics) is forcibly leading us.
‘Cell-based flu vaccines have major advantages over the traditional manufacturing process, including unlimited supply, a shorter production time, and an alternative for persons allergic to eggs. They may also be better suited for developing a shield against the potential pandemic threat of a deadly H5N1 bird flu mutation. But their effectiveness had yet to be fully tested in a large-scale clinical trial, according to the authors.’ Office for Preparedness & Response, Biomedical Advanced Research & Development Authority funded study
The Rockefeller Foundation recently published “Scenarios for the Future of Technology and International Development’; an in depth examination of society under various degrees/types of dictatorial ‘governance’ - the implications that, given a total societal collapse, humans would willingly relinquish their already limited freedoms in exchange for manageable order; a grave reminder of how the so called ‘useless eaters’ or ‘bottom feeders’ are perceived by the elites, as essentially passive & malleable, subject to conditioning on a flowchart. The Rockefeller vision, a dystopic clinical analysis of human behavior in response to a major pandemic leaves little doubt as to the ultimate purpose behind the veil of misguided over-reaching philanthropy.
Excerpt from study: Scenario Narratives: LOCK STEP – A world of tighter top-down government control and more authoritarian leadership, with limited innovation and growing citizen pushback:
In 2012, the pandemic that the world had been anticipating for years finally hit. Unlike 2009’s H1N1, this new influenza strain — originating from wild geese — was extremely virulent and deadly. Even the most pandemic-prepared nations were quickly overwhelmed when the virus streaked around the world, infecting nearly 20 percent of the global population and killing 8 million in just seven months, the majority of them healthy young adults.
Note: Rockefeller time-line: “Unlike 2009’s H1N1, this new influenza strain — originating from wild geese — was extremely virulent and deadly.” vs Office for Preparedness & Response, Biomedical Advanced Research & Development Authority funded projections: “They may also be better suited for developing a shield against the potential pandemic threat of a deadly H5N1 bird flu mutation.”
Research on the H1N1 Virus/Bacterium hybrid for bioweaponry purposes traces back to a little known Rockefeller funded project. During 1942 the Rockefeller Institute for Medical Research, centered in Princeton, New Jersey, undertook a major study titled ‘Synergistic Action Of Hemophilus Influenzae Suis And The Swine influenza Virus On The Chick Embryo’ led by Frederik B. Bang, M.D. through the Department of Animal and Plant Pathology.
The darker implications of their discovery, the harnessing of animal-human live viruses & bacterium for bio-weaponry purposes (H1N1 Swine flu + H1N2 Swine flu + H5N1 Bird flu + H3N2 Human flu + Bacteria = Pandemic) cannot be ignored given the Rockefeller history of involvement in the eugenics movement; suggesting more than just a benign generosity of enlightened philanthropists at work.
“We have found that the combined infection of embryos with swine influenza virus and H. infl~nzae suis produces a highly lethal infection, while neither one alone kills many embryos. Infection with the virus allows the Hemophilus to persist longer than it does in normal embryos.
Finally the combined infection has a selective destructive effect on the embryo lungs.” Frederik B. Bang, M.D/1942
Summary: ‘The synergistic effect of Hemophilus influenzae suis and swine influenza virus in the pig can be reproduced by the inoculation of these agents on the chorioallantoic membrane of 9 to 10 day old chick embryos. Two strains of human influenza virus that were studied failed to substitute for the swine virus in the synergistic reaction. No loss of synergistic effect was noted when the swine influenza virus was put through 11 chick embryo passages. Recently isolated and old stock strains of Hemophilus were equally able to enhance the effect of the virus. Heat-killed cultures of H. influenzae suis can be substituted for the bacterial component of the reaction. Infection of the embryo with swine influenza virus predisposes to infection with H. influenzae suis.
The combination of H. influenzae suis and swine influenza virus causes a selective destruction of the embryo lungs, not produced by the individual components. This pneumonia exhibits the essential features of the natural disease.’
On its face synthetic vaccine technology is clearly a rejection of God, and by extension a rejection of nature itself, the natural principles of life; ultimately a rejection of humankind. Self-determination of the body will not have a place in this Brave New World. “Within thirty years, we will have the technological means to create superhuman intelligence. Shortly after, the human era will be ended.” Vernor Vinge, computer scientist, author of ‘Technological Singularity‘.
‘The moral status of an infant is equivalent to that of a fetus in the sense that both lack those properties that justify the attribution of a right to life to an individual. Both a fetus and a newborn certainly are human beings and potential persons, but neither is a ‘person’ in the sense of ‘subject of a moral right to life’. We take ‘person’ to mean an individual who is capable of attributing to her own existence some (at least) basic value such that being deprived of this existence represents a loss to her. This means that many nonhuman animals and mentally retarded human individuals are persons, but that all the individuals who are not in the condition of attributing any value to their own existence are not persons.
Merely being human is not in itself a reason for ascribing someone a right to life. Indeed, many humans are not considered subjects of a right to life: spare embryos where research on embryo stem cells is permitted, fetuses where abortion is permitted, criminals where capital punishment is legal….Although fetuses and newborns are not persons, they are potential persons because they can develop, thanks to their own biological mechanisms, those properties which will make them ‘persons’ in the sense of ‘subjects of a moral right to life’: that is, the point at which they will be able to make aims and appreciate their own life.‘ Excerpt from ‘After-birth abortion: why should the baby live?’ – authors Giubilini A, Minerva F. Journal of Medical Ethics/2012
Our bodies are sovereign territory and subject to our exclusive self-determination. Any attempted violation of this trust must be construed as a breach of that basic right. May natural immunity be your guiding light through these uncertain times ahead. Words to live by.
VRM: The Autism Report http://vaccineresistancemovement.org/?p=10185
VRM Worldwide Autism Study
Direct link to study: http://study.vaccineresistancemovement.org/
VRM: The Problem With Vaccines Part 1
VRM: The Problem With Vaccines Part 2 – Synergistic Effect of Heavy Metal Toxicity On The Body
VRM: Vaccine Clinic – A Concise Compendium To The Problem With Vaccines
VRM: A Concise Compendium To The Problem With Vaccines Part 3 – Synthetic Genomics & The Death Of Natural Immunity
VRM: The Problem With Vaccines Part 4 – Primary Aspects of Vaccine Toxicity Affecting Body
VRM: The Problem With Vaccines Part 5A – Detoxification & Restoration of the Body
VRM: The Problem With Vaccines Part 5B – Detoxification & Restoration of the Body
VRM: PCV Vaccine Exposed – Breeding Ground For Staphylococcus Aureus
VRM: The Flu Report
VRM: Vaccine Ingredients
VRM: Safe Alternatives to Vaccines
VRM: Family Charts Gradual Decline Of Daughter
VRM: Autism – Steps To Take Toward Prevention
VRM: Health Matters Part 1
VRM: Health Matters Part 2
VRM: Alternative Cancer Cures That Work
VRM: Pregnancy Tips
VRM: H1N1 Shot Reactions – Miscarriages
VRM: The Vanishing Sperm Count
VRM: H1N1 Vaccine Surplus From 2009 Reveals Growing Distrust of Gov’t & WHO
VRM: Flu Death Statistics – WHO & The Big Lie
VRM: Vaccine Industry Deception, Propaganda & Media Collusion
VRM: Birth of Medical & Scientific Dictatorship – Future Scenarios
VRM: H1N1 Bio-weaponry Incorporated
VRM: Aids & The WHO Connection – Criminal Intent
VRM: Morgellons Syndrome & Chemtrails
VRM: Council On Foreign Relations 10/16/09- Major Influence on Government Vaccine Policy
VRM: Closed Door CDC Meeting Reveals Industry Cover-up Of Heavy Metal Toxicity In Vaccines
VRM: The Rockefeller Foundation Drafts A Post-Pandemic Scenario
VRM: World Health Organization & Vaccine Manufacturers Implicated In Massive H1N1 Financial Scam Involving Kickbacks & Cover-ups
VRM Live – 01/28/11: Vaccine Resistance Movement founder Joel Lord discusses Synthetic Genomics, cloned cell vaccine technology & the death of natural immunity, gutter journalism & Dr. Wakefield’s imminent vindication with ‘Truth to Power’ host Paul Mabelis.
VRM Live - 11/04/10: Vaccine Resistance Movement founder Joel Lord lays out the whole vaccine process with Paul Mabelis; including heavy metal toxicity, synergy, pregnancy issues & the basic principles of natural health at risk.
VRM Live - 09/24/10: Vaccine Resistance Movement Founder Joel Lord & activist/radio host Jesse Calhoun lay it all out tonite. Topics include the VRM Worldwide Autism Study, Scientific/Medical dictatorship, Natural Rights & Vaccine Industry fraud exposed. Special thanks to host Paul Mabelis.
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