The Food and Drug Administration approved the new swine flu vaccine Tuesday, a long-anticipated step as the government works to get vaccinations under way next month. Studies in children and pregnant women are continuing. The vaccine approved Tuesday is made by CSL of Australia; Switzerland's Novartis; Sanofi-Pasteur of France; and Maryland-based Medimmune, which makes the only nasal-spray flu vaccine.FDA approved “the vaccine”? Four different vaccine manufacturers are listed and they all make a completely different product, each as different as chalk and cheese, yet they are all reported as “the new swine flu vaccine”
Extracts from Baxter H1N1 patentHilleman determined that poliovirus replicated well in AGMK cells. As a test to determine that the poliovirus was inactivated by this treatment, he placed the formalin inactivated poliovirus vaccine, which did not grow in rhesus cells and was inactivated, onto these AGMK cells. Surprisingly he saw the cytopathic effects of a virus in the vaccine extract that had been made in rhesus cells. The rhesus cells themselves harbored a virus that had no cytopathic effects in rhesus and that failed to be inactivated by the formalin treatment that killed the polio virus, and this new virus, which was named Simian Vacuolating Virus 40 or SV40, replicated and killed AGMK cells. As Hilleman stated in his publication about this surprising result; “The discovery of this new virus, the vacuolating agent, represents the detection for the first time of a hither-to “nondetectable” simian virus of monkey renal cultures and raises the important question of the existence of other such viruses” Antibodies directed against SV40 could be detected in five of seven children who received the Salk vaccine.
The present invention provides a method for the manufacture of a preparation comprising virus antigens comprising:
- inoculation of cells with infectious virus in a fluid
- propagation of said virus in said cells
- collecting said propagated virus
- inactivating said collected virus, and
- treating said inactivated virus with a detergent, resulting in a preparation comprising viral antigensIn another aspect the present invention provides the method of increasing the resistance to a viral infection in a subject comprising manufacturing a preparation comprising viral antigens and administering said preparation to a subject.
Extracts from the Detailed Description of InventionAn essential step in the production of viral vaccines is the inactivation of the infectious viruses. Formalin is the most frequently used inactivating agent, usually around 37% formaldehyde. Ultraviolet (UV) irradiation has been considered for integration into the manufacturing process. By combining formalin and UV, scientists tried to overcome the limitations of one isolated method when inactivating particularly resilient virus families. Alternatively many manufacturers use detergent to inactivate or modify the live virus. This process disrupts the lipid envelope of influenza viruses to yield either split (partially disrupted) or sub-unit (fully disrupted) vaccine antigen.
 e) treating said inactivated virus with a detergent, resulting in a preparation comprising antigens. Central to this procedure is that it is possible to reduce the number of steps performed on an active virus and thus the virus is inactivated after collection of the primary harvest prior to the detergent treatment and/or optional purification steps.  in a further embodiment of the present invention, the cells use for cell culture and viral propagation may be primary cells or any cultured cell line. Examples of cells which may be used include mammalian (e.g., CHO, BHK, VERO, HELA, or perC6), avian and insect.
 in embodiments of the invention, the virus is modified by detergent treatment to produce a modified whole virus or split virus vaccine. Suitable detergents include Tween 80 and Triton X100.  in further embodiments a vaccine composition is provided which comprises one or more viral antigens. Such a composition can further comprise a pharmaceutical carrier and/or an adjuvant. A further aspect of the present invention is a pharmaceutical composition or preparation as vaccine comprising an antigen.
 suitable adjuvants can be selected from mineral gels, aluminium hydroxide, lysolecithin, or oil emulsions.
 three different influenza strains, two A-strains Hiroshima (HR, H3N2), a New Caledonia (NC, H1N1) and a B-strain, Malaysia (MA), were produced in Vero cell cultures.
 Benzonase, a recombinant nuclease produced in E. coli, is added to the virus suspension at a final concentration of 3 U/ml to degrade cell derived DNA.
 for virus splitting, Triton X100 is added to a final concentration of 0.5% (w/w) and incubated over night at room temperature.
 formalin is added into the Ultra/Diaretentate to a final concentration of 0.025% for antigen stabilization. Formalin is a saturated acqueous solution of 36-37% formaldehyde gas.
 for the New Caledonia strain at the end of purification, total Vero protein could be reduced from 8mg to 2mg from the Peak Pool to the Monovalent Bulk (MVB). Vero DNA content in the MVB was 0.27 µg. Total protein was reduced from 382mg to 162mg.
A spike-shaped protein that extends from the surface of the virus, the name to the ability of influenza to agglutinate red blood cells: the virus is covered with many hemagglutinin molecules, which together can glue many red blood cells together into a visible clump.
Human flu viruses have a neuraminidase enzyme, signified in the name "H#N#", where the H refers to an isoform of hemagglutinin and N refers to an isoform of neuraminidase.
US Patent 5200320 - Method for identifying useful polypeptide vaccines In order to immunize an animal (including humans) against a particular infectious agent, it is necessary to activate T-cells specific for a protein (antigen) derived from the agent. It has previously been suggested that the final step in this activation of T helper cells is the creation of a trimolecular complex consisting of major histocompatibility complex (MHC) II molecules (Ia molecules), `processed` antigenic protein (both on antigen presenting cells -APC), and the T-cell receptor. As a necessary step in the formation of the foregoing complex, the processed antigen must bind to Ia molecules of the APC of the individual animal to be immunized. For a number of reasons, synthetic peptides derived from infectious agents may be useful as vaccines.
Polypeptides, polynucleotides, methods, compositions and vaccines comprising (avian pandemic) influenza hemagglutinin and neuraminidase variants are provided.  live attenuated virus vaccines have the advantage of being able to stimulate local mucosal immunity in the respiratory tract. Considerable work in the production of influenza viruses, and the fragments thereof, for production of vaccines has been done by the present inventors and co-workers.* 293T - Human Embryonic Kidney cells, also often referred to as HEK 293.
 because of the continual emergence (or re-emergence) of different influenza strains, new vaccines are continually desired. Such vaccines are created using antigenic moieties of the newly emergent virus strains, thus, polypeptides and polynucleotides of novel, newly emergent, or newly re-emergent virus strains (especially sequences of antigenic genes) are highly desirable.
 the present invention provides new and/or newly isolated influenza hemagglutinin and neuraminidase variants that are capable of use in production of numerous types of vaccines.
 Methods for stimulating the immune system of an individual to produce a protective immune response against influenza virus, through administering an immunologically effective amount of such recombinant influenza virus in a physiologically acceptable carrier are also part of the invention.
 The term “host cell” means a cell that contains a heterologous nucleic acid, such as a vector, and supports the replication and/or expression of the nucleic acid. Host cells can be prokaryotic cells such as E. coli, or eukaryotic cells such as yeast, insect, amphibian, avian or mammalian cells, including human cells. Exemplary host cells can include, eg., Vero (African Green Monkey kidney) cells, BHK (baby hamster kidney) cells, primary chick kidney (PCK) cells, Madin-Darby Canine Kidney (MDCK) cells, Madin-Darby Bovine Kidney (MDBK) cells, 293 cells (eg., 293T cells), and COS cells (eg., COS1, COS7 cells), etc.
 various embodiments of the invention utilize A/Ann Arbor (AA)/6/60 influenza strain as a “backbone” upon which to add HA and/or NA genes to create desired reassortant viruses.  Live attenuated influenza A virus vaccines against human influenza viruses were recently licensed in the US. Such vaccines are reassortant H1N1 and H3N2 viruses. Classical genetic reassortment and plasmid-based reverse genetics techniques have been applied to generate reassortant viruses that contain the Hemagglutinin and Neuraminidase genes from avian influenza A viruses. The generation and evaluation of these reassortant viruses as seed viruses for vaccines are important steps in pandemic preparedness.These two patents paint a horrific picture from the world of mad science vaccine production. The MedImmune/NIH patent is just mind boggling in the way it casually advocates for example that; suitable adjuvants include complete Freund’s adjuvant.
 The term “cold adapted” (ca) indicates that the virus exhibits growth at 25˚ C. within 100 fold of its growth at 33˚ C., while the term “attenuated” (att) indicates that the virus replicates in the upper airways of ferrets but is not detectable in their lung tissues.
 A related aspect of the invention provides methods for stimulating the immune system of an individual to produce a protective immune response against influenza virus. In the methods, an immunologically effective amount of a recombinant influenza virus (eg., comprising an HA and/or NA molecule of the invention), an immunologically effective amount of a polypeptide of the invention, and/or an immunologically effective amount of a nucleic acid of the invention is administered to the individual in a physiologically acceptable carrier.
 Generally, the influenza viruses of the invention are administered in a quantity sufficient to stimulate an immune response specific for one or more strains of influenza virus (i.e., against the HA and/or NA strains of the invention).
 Typically, the attenuated recombinant influenza of this invention as used in a vaccine is sufficiently attenuated such that symptoms of infection, or at least symptoms of serious infection, will not occur in most individuals immunized (or otherwise infected) with the attenuated influenza virus. In some instances, the attenuated influenza virus can still be capable of producing symptoms of mild illness and/or dissemination to unvaccinated individuals.
 Optionally, the formulation for prophylactic administration of the influenza viruses also contains one or more adjuvants for enhancing the immune response to the influenza antigens. Suitable adjuvants include: complete Freund’s adjuvant, aluminium hydroxide, oil or hydrocarbon emulsions, Bacille Calmette-Guérin (BCG) and Corynebacterium parvum.
 The present invention also relates to host cells that are introduced (transduced, transformed or transfected) with vectors of the invention, and the production of polypeptides of the invention by recombinant techniques. Host cells are genetically engineered (i.e., transduced, transformed or transfected) with a vector, of this invention.
 Most commonly, mammalian cells are used to culture the HA and NA molecules of the invention. Suitable host cells for the replication of influenza virus include, e.g., Vero cells, BHK cells, MDCK cells, 293 cells and COS cells. Commonly, co-cultures including two of the above cell lines, e.g., MDCK cells and either 293T or COS cells are employed at a ratio, e.g., of 1:1, to improve replication efficiency.
The classic oil-based adjuvant called Freund’s Complete Adjuvant can cause permanent organ damage and irreversible disease – specifically autoimmune diseases. When scientists want to induce autoimmune disease in a lab animal, they inject it with Freund’s Complete Adjuvant.And the “suitable and/or exemplary host cells” for propagating the viruses that go into the vaccines, unbelievable! Chinese hamster, African Green Monkeys crossed with monkey virus genome, cancerous cells, human embryonic cells, dogs, and the icing on the cake, splicing dog and human embryonic cells together to “improve replication efficiency”.
Vaccines have not eradicated diseases: vaccines spread diseases. Attenuated viruses (infective, weakened versions of the dangerous ones) are commonly used in vaccines. This practice derives from the dawn of vaccination: Edward Jenner’s pioneering use of cowpox pus inoculations to eliminate smallpox. It makes a wonderful story but, in fact, inoculation not only spread smallpox, it caused well-documented epidemics of syphilis and leprosy in inoculated people.The “Horrors of Vaccination Exposed and Illustrated” published in 1920 by Chas Higgins, Higgins writes of the 1918 Spanish H1N1 flu pandemic.
When a live virus is used in the vaccine, infective virus is shed for anywhere from 4 to 21 days (or more) and, during that time, inoculated persons can give the disease, or the side effects of the inoculation, to any vulnerable person they come into contact with.
Neither Jenner’s cowpox inoculation nor modern smallpox inoculation did anything to eliminate smallpox (quite the contrary). The fact is Dr. Charles Campbell discovered that smallpox is transmitted by the flying bedbug, Cimex lectularius, and that eliminating this parasitic insect from human habitation eliminates smallpox too. Personal hygiene and better housekeeping eliminated the deadly scourge. (Dr. Campbell also discovered that the disfiguring pocks of the disease could be prevented by a diet high in Vitamin C.)
When the World Health Organization (WHO) declared the planet “smallpox free” in 1980, they did so administratively, not medically: small pox incidence was reduced, but not gone, despite nearly universal vaccination. What to do? WHO solved the problem cleverly: they renamed the disease “cowpox” and “monkey pox”. Shazam: a smallpox free planet, quicker than you can say, “Junk Science!”
Despite the considerable hype, in fact, there is no unbiased evidence which connects disease prevention with inoculation.
In a previous letter to the Secretary of War, dated October 14, 1918, I have pointed out the dangerous nature of vaccination, particularly during epidemics, and the hygienic importance of suspending all vaccination during our recent epidemic of influenza and pneumonia. I also then called attention to the probability that the repeated and multiple vaccinations of millions of men, in this country and Europe, with various septicemic infections for the last two years, may have had some relation to this epidemic, which seems to have been more severe among the vaccinated men in the military camps and hospitals than among the rest of the population.
From the rapidity, severity and mortality of this disease, it would seem not to be a true influenza as its worst cases are characterized by septic pneumonia, with abscesses in the lungs. This suspicion is strengthened by the fact that the chief germ found in the fatal cases is the “streptococcus,” which is found in the worst forms of blood poisoning or “septicemia.” The act of ordinary vaccination is in itself, an act of blood poisoning, pure and simple. It is also classed in medical and statistical works as a form of “septicemia” and one disease germ commonly found in vaccine virus is the streptococcus, which is the chief germ found in all bad pus infections and abscess formations.
Therefore, as the act of vaccination is simply the impregnation of the body and blood with a pus infection identical with “septicemia”, and this process has been repeated in tens of thousands of men closely massed in camps, should it be any wonder if an epidemic of some sort of “septicemia” should crop out at some time under such conditions?
Is it physically or medically possible to go on sowing and spreading some known and unknown septic diseases at wholesale, within human bodies, without reaping some big harvest of deadly septic diseases as a necessary consequence?