First scientific, peer-reviewed publication showing the candidate vaccine induced neutralizing antibodies against widely divergent H5N1 virus
DEERFIELD, Ill., June 11 /PRNewswire-FirstCall/ -- Baxter InternationalInc. (NYSE: BAX) announced publication in the June 12, 2008 issue of The NewEngland Journal of Medicine (NEJM) of data demonstrating Baxter's candidateavian influenza (H5N1) vaccine, CELVAPAN, met Phase I/II trial endpoints forsafety and immunogenicity (generating a functional immune response). This isthe first peer-reviewed publication of study results for CELVAPAN, the firstcell culture-derived avian influenza vaccine to undergo clinical evaluation.The primary authors of the manuscript are Hartmut J. Ehrlich, MD, vicepresident of global research and development for Baxter's BioScience business,and Noel Barrett, vice president of Baxter's vaccines research.
'Cell culture technology could represent the future of influenza vaccineproduction,' said John Oxford, professor of Virology, The Queen Mary School ofMedicine, London, United Kingdom. 'Baxter has demonstrated the ability torapidly make large quantities of the vaccine that may protect people againstdivergent H5N1 viruses.'
Based on manufacturing processes, Vero cell technology may offer severaladvantages versus conventional egg-based vaccine technology. Baxter's Verocell manufacturing process is more rapid due to its ability to use a 'native'virus that does not need to be modified to allow growth in chicken eggs,therefore accelerating vaccine production.
'CELVAPAN combines innovative science and breakthrough productiontechnology with the aim of protecting people against an H5N1 pandemic fluinfection,' said Hartmut J. Ehrlich, MD. 'This is an immunogenic vaccinewithout the need for an adjuvant to boost the immune response.'
About CELVAPAN
CELVAPAN is manufactured in a cell culture-based system in Bohumil, CzechRepublic, at one of the largest cell culture vaccine production facilities inthe world. Vero cell technology uses a well-established cell line originallyderived from African green monkey kidneys in 1962. A continuous cell line hasbeen derived from these cells so that an unlimited supply of cells isavailable without the requirement of generating additional cells from animals.
Baxter's candidate avian flu vaccine is derived from the H5N1 strainA/Vietnam/1203/2004. Its antigen composition and structure are identical tothe actual virus circulating in nature without the need to enhance an immuneresponse by including adjuvants, additives that may cause side effects. Inthis Phase I/II study, CELVAPAN induced an immune response that is similar tothe body's defense against a natural virus infection.
