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Sanofi-Aventis starts Phase II flu jab

1. [verwijderd] 26 september 2008 12:57

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   FDA Panel: Data Okay For Next Step In Flu Vaccine > AZNLast update: 9/25/2008 4:51:09 PM
   
   By Jennifer Corbett Dooren
   Of DOW JONES NEWSWIRES
   WASHINGTON (Dow Jones)--A Food and Drug Administration panel of medical experts said Thursday that preclinical data looking at the safety of cells that could be used to produce a next-generation nasal-spray influenza vaccine by MedImmune Inc. were adequate to support testing in humans. MedImmune, a Gaithersburg, Md., unit of AstraZeneca PLC (AZN), currently uses chicken eggs to grow influenza strains that are used in the company's influenza vaccine. Flu-shot makers, which include Sanofi Pasteur, a unit of Sanofi-Aventis (SNY), GlaxoSmithKline PLC (GSK) and Novartis AG (NVS), also grow strains in chicken eggs. However, U.S. health officials are hoping to eventually move influenza-vaccine production away from egg-based production toward other technologies such as cell-cultures that could offer a faster and more reliable way to make flu vaccines. Most vaccine makers currently have cell-based vaccines at various stages of development. One cell line being tested by vaccine makers was originally derived from dog kidneys. But, because cell-lines are derived from animal tissue, there are remote concerns about whether the cells could produce tumors in vaccine recipients. While most panel members on the FDA's vaccine-advisory committee said the data MedImmune has generated to date about its cell lines were adequate and the company could move to human testing in the development of the vaccine, three of the panel's 13 voting members wanted additional information about the size of certain particles derived from the cells. "It's the unknown that makes us nervous," said Steven Self, a professor at the Fred Hutchinson Cancer Research Center in Seattle. In 2005, another FDA panel of outside medical experts met to discuss the use of cell cultures being developed for influenza vaccines by Novartis and Solvay Pharmaceuticals (SOLB.BT). That panel said the inactivation and purification steps used to produce the vaccine were stringent enough to mitigate potential safety concerns. Flu shots are made using inactive influenza strains while MedImmune's nasal spray is made with altered "live" influenza strains, which is way the issue of cell-line safety was again brought to the panel. In 2006, the U.S. government awarded more than $1 billion in federal contracts to a handful of companies including MedImmune, Novartis and Glaxo to speed the development of cell-based influenza vaccines for use in a flu pandemic or the seasonal flu. Health experts are concerned that the H5N1 virus responsible for avian flu, or a similar virus, could cause the next flu pandemic if it mutates and begins rapidly spreading among humans. -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
2. flosz 26 september 2008 13:07

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   quote:

   Dirk R. Wijnen schreef:

   One cell line being tested by vaccine makers was originally derived from dog kidneys. But, because cell-lines are derived from animal tissue, there are remote concerns about whether the cells could produce tumors in vaccine recipients.
   
   In 2005, another FDA panel of outside medical experts met to discuss the use of cell cultures being developed for influenza vaccines by Novartis and Solvay Pharmaceuticals (SOLB.BT). That panel said the inactivation and purification steps used to produce the vaccine were stringent enough to mitigate potential safety concerns.
   

   Ter aanvulling (again).
   
   Tumorgenicity PER.C6-> MDCK
   Analyst Briefing
   April 27, 2006
   Pagina 51,
   hugin.info/132631/R/1052315/174665.pdf
   
   FDA slides: www.fda.gov/ohrms/dockets/ac/05/slide...
   
   scaleability is key!
   www.crucell.com/page/downloads/Goudsm...
   
   A novel high trough-put assay for influenza virus titration on PER.C6TM suspension cells
   Marzio G., Pau M.G., Lonsdale R., Vooys A., Ophorst A., Oerlemans M., Pasma J., UytdeHaag F., (Crucell Holland BV, Leiden, The Netherlands)
   
   Reliable methods for the quantification of virus replication are of crucial importance in a variety of studies. Applications include efficacy assessment of antiviral drugs, identification of viral phenotypes with altered replication capacity, and selection of viral strains for vaccine production.
   
   In the case of influenza virus, a commonly adopted definition of infectious titer is based on the appearance of cytopathic effect in cultured Madin-Darby canine kidney (MDCK) cells. MDCK represents the cell line of choice because of its susceptibility to influenza virus infection that results in the formation of distinct plaques, which can be easily counted. Although sensitive and reliable, the plaque assay on MDCK is time and labor consuming. Moreover, since the appearance of plaques requires several rounds of replication, titers may also reflect the ability of the virus to replicate in MDCK cells rather than the initial number of infectious particles per se.
   
   Here we describe a novel assay for titer determination of influenza viruses based on PER.C6TM suspension cells and fluocytometry. Our system represents a major improvement over other currently used methods due to its rapidity and ease of execution. Accurate titers can be obtained within three hours using PER.C6™ suspension cells at five hours post infection, as opposed to one week for plaque assay on adherent MDCK cells. Our results show that this system can be applied to A as well as B influenza viruses and that titers truly reflect the number of infection-competent particles in the supernatant.