To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Pre-Pandemic Vaccine Approved in EU to Protect Against H5N1 Influenza URL: http://www.pslgroup.com/dg/221ADA.htm Doctor's Guide May 20, 2008
NEW YORK -- May 20, 2008 -- The European Commission has granted marketing authorisation for GlaxoSmithKline's H5N1 adjuvanted pre-pandemic vaccine, Prepandrix, in all 27 EU member states. The vaccine is formulated with a novel proprietary adjuvant system, designed to achieve a high immune response at a low dose of antigen which is long-lasting and active against a broad range of H5N1 strains. H5N1 influenza, often referred to as avian influenza, can lead to severe disease in both birds and humans. Public health experts fear that this virus may evolve into a strain that is easily transmitted between people, triggering a worldwide pandemic. Such pandemics involve viruses to which humans have little or no immunity, such as H5N1. The virus has also shown that it can replicate in humans and cause serious illness and death. The first cases in humans were reported in Hong Kong in 1997, with 18 cases and 6 deaths -- a high case-versus-fatality rate. There have been isolated reports of H5N1 transmission from human to human, but as yet no reports of sustained human-to-human transmission. The European Union license for this vaccine, granted for use in patients aged 18 to 60 years, is based on data from a number of trials which evaluated the safety, reactogenicity, immunogenicity, and cross-protection of the pre-pandemic vaccine using the Vietnam strain, a WHO-recommended strain. In one of the pivotal trials, the vaccine, which uses the antigen from the H5N1 A/Vietnam/1194/04 strain, demonstrated at least a 4-fold increase in serum neutralising antibodies in 77% to 85% of subjects against 3 distinct H5N1 strain variants: A/Indonesia/5/05, A/Anhui/1/05, and A/turkey/Turkey/1/05 (Leroux-Roels I et al. PLoS ONE. 2008;3:e1665). As it is not possible to predict the actual pandemic influenza virus strain, it is important for a pre-pandemic vaccine to show protection against a number of possible viral strains. The immune response elicited by GlaxoSmithKline's pre-pandemic vaccine against H5N1 variants currently circulating in Asia, Europe, and Africa demonstrates the possibility of protection against an eventual H5N1 pandemic strain. The vaccine has also shown cross-protection in preclinical studies, preventing mortality in 96% of cases following 2 doses of adjuvanted vaccine (Baras B et al. PLoS ONE. 2008;3:e1401). These studies also demonstrated that the vaccine is generally well tolerated. Source: GlaxoSmithKline --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.