CEL-SCI Expands Testing Of Its Vaccine To Determine Efficacy Against More Virulent Strain Of H1N1 Swine And Other Influenza Viruses
June 10, 2009 by fluoutbreak · Leave a Comment
CEL-SCI Corporation (NYSE Amex: CVM) announced that it is expanding the pre-clinical testing of its flu vaccine, utilizing its proprietary L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System) to determine its efficacy against the more dangerous and virulent virus strains that may arise during the up coming winter flu season. The Company has begun pre-clinical formulation, evaluation and testing of a new application of its L.E.A.P. S vaccine, which will allow the targeting of “mutated” versions of H1N1 swine and other influenza viruses. It is believed that the influenza virus may mutate and evolve between now and the winter flu season. In conjunction with the testing, CEL-SCI has produced several L.E.A.P.S. flu vaccines that focus on the conserved, non changing epitopes of the different strains of Type A Influenza viruses (H1N1, H5N1, H3N1, etc.), including “swine”, “avian or bird”, and “Spanish Influenza”, in order to minimize the chance of viral “escape by mutations” from immune recognition. CEL-SCI’s L.E.A.P.S. flu vaccine contains epitopes known to be associated with immune protection against influenza in animal models. The Company had previously announced that it had begun pre-clinical testing of swine and H1N1 flu viruses, which were non-mutated versions of the virus.
The use of L.E.A.P.S. vaccine technology for immunization in animal models has already been shown to provide protection from viral diseases without causing an immune response associated with the deadly “cytokine-storm” seen in many of the victims of influenza.
Dr. Daniel Zimmerman, inventor of the L.E.A.P.S. technology, and currently a consultant to CEL-SCI, said, “Various L.E.A.P.S. technology constructs have already been shown to induce protection in animal challenge models against a variety of diseases such as malaria and herpes simplex virus and as therapeutic vaccines in two different autoimmune conditions. Data showed that L.E.A.P.S. vaccines were able to induce these protective immune responses without the excessive induction of pro-inflammatory cytokines. This is thought to be very important in the swine flu, or the avian flu, since it appears that the excessive production of pro-inflammatory cytokines during the course of the disease is responsible for and may lead to the increased number of deaths from these illnesses.”
Placing a vaccine order with crooks and liars
June 2, 2009 by fluoutbreak · Leave a Comment
Ten days ago Secretary of Health and Human Services Kathleen Sebelius announced that the US government was allocating $1 billion to help companies with production costs for a swine flu vaccine. Among the beneficiaries was French vaccine giant, Sanofi-Aventis, whose Sanofi Pasteur unit got a $190 million order. It was likely only the first in a series of expected orders for the company. Sanofi knows how to make vaccines. So what could go wrong?
Drugmaker Sanofi-Aventis has agreed to pay nearly $100 million to settle allegations it cheated Medicaid on the cost of nasal sprays.The Justice Department said Aventis Pharmaceutical Inc., a wholly owned subsidiary of Sanofi-Aventis U.S. LLC, has agreed to pay the government $95.5 million to settle the charges.
The government charged that between 1995 and 2000, Aventis and its corporate predecessors did not offer Medicaid the best prices for the sprays Azmacort, Nasacort and Nasacort AQ.
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Under the law, the company was required to tell Medicaid the lowest price that it charged companies for those products, and offer state Medicaid programs rebates based on those prices.
Helen Branswell on WHO and vaccine decision
May 27, 2009 by fluoutbreak · Leave a Comment
International public health officials signalled Tuesday they are playing for time on the thorny questions of how much swine flu vaccine to make and then whether to use it.
Officials of the World Health Organization and the U.S. Centers for Disease Control acknowledged they hope to put off for as long as possible these difficult decisions, made more challenging by the mildness of the H1N1 swine flu virus.
The WHO’s top flu expert said he doesn’t expect the Geneva-based agency to make any recommendations on whether manufacturers should go into widescale production until early summer.
And the director of the CDC’s national centre of immunization and respiratory diseases said the U.S. may not take a decision on who to vaccinate until late summer or early fall.
“It is going to be a very difficult and complicated discussion if the situation remains as it does at the time when decisions have to be made,” admitted Dr. Keiji Fukuda, the WHO’s acting assistant director general of health security and environment.
HHS Takes Additional Steps Toward Development Of Vaccine For The Novel Influenza A (H1N1)
May 26, 2009 by fluoutbreak · Leave a Comment
HHS Secretary Kathleen Sebelius announced today that the department will take important steps necessary to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A ( H1N1). The Secretary is directing approximately $1 billion in existing funds that will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.
“Preparation and planning are critical to keep Americans safe in the face of a potential pandemic,” Secretary Sebelius said. “Our goal throughout this new H1N1 outbreak has been to stay one step ahead of the virus. An important part of this effort has been our work to develop a potential vaccine because vaccines can help prevent and control influenza virus outbreaks. The actions we are taking today will help us be prepared if a vaccine is needed.”
The funds will be used to place new orders on existing contracts with companies that hold U.S. licenses for flu vaccines. With these orders, they will produce a bulk supply of vaccine antigen and adjuvant. Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvants could be added to a vaccine to improve the immune system’s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.
Russian researchers will soon begin to create a vaccine
May 25, 2009 by fluoutbreak · Leave a Comment
25.05.2009, 06.42
MOSCOW, May 25 (Itar-Tass) – Russian researchers will soon begin to create a vaccine against the H1N1 swine flu.
The strain of the virus was received from a first swine flu patient, a Russian citizen, who returned from the U.S.
“At present, specialists have juridical grounds to use it (the strain) to produce the vaccine,” the director of the Ivanovsky Institute of Virology, Dmitry Lvov, said.
On Sunday, the head of the Russian consumer rights watchdog, Gennady Onishchenko, said a second case of the H1N1 virus was confirmed in Russia. The tests proved that a resident of the Kaluga region who returned from the Dominican Republic contracted the H1N1 flu. The man is held under medical supervision.
Rospotrebnadzor instructed to toughen control at Moscow’s airports over citizens arriving from foreign countries. All airports installed special thermal scanners.
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http://www.itar-tass.com/eng/level2.html?NewsID=13973042&PageNum=0
Scientists begin analyzing viruses that could lead to vaccine
May 24, 2009 by fluoutbreak · Leave a Comment
WASHINGTON (AP) – Inching closer to a swine flu vaccine, the government is beginning to analyze two candidates for the key ingredient to brew one.
The Centers for Disease Control and Prevention hopes to deliver one or both to vaccine manufacturers by the end of next week so scientists can begin the months-long process of producing shots.
Friday, the government set aside $1 billion for crucial testing of the first pilot doses and stockpiling of key vaccine ingredients – in case world health authorities decide that people indeed need to be vaccinated starting sometime next fall. The stockpile will allow for quick production of shots to protect health workers and other people at high-risk from flu.
Also on Friday, CDC scientists unveiled the most detailed genetic examination yet of the novel virus, finding that the new swine flu may have been circulating undetected in pigs for years.
That report, in the journal Science, still fails to solve the bigger mystery of when and where the virus made the jump to people and what genetic change allowed it to start spreading so rapidly. The virus was first detected last month, and at least 42 countries now have confirmed it in more than 11,000 people. At least 85 people have died from it.
The confirmed cases don’t represent anywhere near the full scope of the outbreak: For every reported case of swine flu, there may be 20 people sickened with it, said CDC’s Dr. Anne Schuchat – more than 100,000 people in the U.S. There are signs that it is declining in parts of the country, although school-related outbreaks in New York City and elsewhere have led to the closings of about 60 schools affecting 42,000 students, Schuchat said.
The candidate vaccine viruses the CDC has begun analyzing contain a mix of genes from the new swine flu virus itself with components of other viruses that allow them to grow better in the eggs that manufacturers use to produce vaccine. If one or both prove usable, manufacturers could begin producing pilot lots for testing this summer to see if the shots are safe, trigger immune protection and require one dose or two.
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