The U.S. Food and Drug Administration (FDA) has approved four vaccines for use against the 2009 H1N1 influenza virus. The vaccines—made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc.—will be distributed nationally after the initial lots become available. This is expected to occur within the next four weeks.
The Australian Infection Control Association this week warned the government against proceeding with the programme, saying that the planned use of multidose vials (used to vaccinate several people) posed a “significant potential risk to patient safety.” The association’s president, Claire Boardman, said that use of multidose vials would contravene national infection control guidelines (www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/02A94EEE98D72244CA25740F00251B98/$File/NationalInfectionControlGuidelines.pdf) and that numerous adverse events related to their use had been well documented.
As manufacturers work furiously to make a vaccine to protect against 2009 influenza A (H1N1) virus, a Rice University bioengineer is trying to improve the process for future flu seasons. The goal is to shorten the time it takes to identify targeted flu strains and manufacture the vaccines for them.
The BioSante presentation, “BioVant Calcium Phosphate (CaP) Nanoparticles: An Effective & Safe Adjuvant for Influenza Vaccines including H1N1 and H5N1,” showed that BioVant-adjuvant effectively enhanced the natural immune response to the swine flu, using a BioVant-adjuvanted matrix protein M1 vaccine, and to H5N1 (bird flu), using a BioVant-adjuvanted H5N1 vaccine delivered via intranasal administration.
MedImmune is putting its FluMist nasal spray technology to the test against swine flu. FluMist, which got off to a shaky start in the U.S., brought in only $104 million last year, a fraction of what the big global manufacturers have been able to earn with their flu shots. But all those naysayers who scorned the terms of the MedImmune buyout in the face of such weak performance could well be silenced by the rewards available when a pandemic hits. AstraZeneca plans to make 200 million doses of swine flu vaccine by next spring.
Analysts note that the pandemic couldn’t have come at a better time for Glaxo, one of the world’s largest vaccine makers. Generics have been steadily eating into the company’s margins, leaving Glaxo looking for new products to make up the shortfall.
An additional $884 million in funding has been allocated to buy more ingredients an antigen and an adjuvant for swine flu vaccines. This is in addition to the $1 billion The Department of Health and Human Services committed to fighting the Swine Flu in May.
San Diego-based Vical, a firm who is developing an H1N1 vaccine under an agreement with the U.S. Navy saw company shares climb 45 cents, to $2.65 on positive clinical trial news this week. Vical researches and develops biopharmaceutical products based on our patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Vical’s stock shot up 20 percent on the news that their swine flu jab sailed through an animal study with positive results. Vical’s H1N1 vaccine is now ready for a human study — marching into the clinic in record time.
Around the world, vaccine manufactures are rushing new swine flu vaccines into clinic trials and booking pre-orders from worried Public Health officials, while epidemiologists are still puzzling out how the new flu works and why many young people without any health complications are often hit the hardest by H1N1.
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