- Clinical Study Demonstrates Breakthrough Dose-Sparing Formulation ThatIncreases Stockpile Capacities and Expands Potential Production Capacities toBillions of Doses in a Pandemic Situation
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Sanofi pasteur, the vaccines division of sanofi-aventis Group, todayannounced data showing that its new investigational H5N1 pandemic influenzavaccine containing a proprietary adjuvant achieved a high immune response atthe lowest dose of H5N1 antigen reported to date.
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The vaccine containing only 1.9 micrograms of antigen generated a highlevel of seroprotective immune response in over 70 percent of theparticipants in a clinical trial and, in the same clinical trial, vaccinecontaining 3.75 micrograms of antigen generated a high level ofseroprotective immune response in over 80 percent of the participants.
Once fully developed, this vaccine should give sanofi pasteur thepotential to provide billions of doses in a pandemic situation and greatlyincreases its ability to produce vaccines for stockpiling in advance of apandemic. This would be a significant achievement for public health and abreakthrough in research and development of pre-pandemic and pandemicvaccines that is fully in line with sanofi pasteur's early commitment tobring answers to the global threat posed by pandemic influenza.
Results are based on analysis of a clinical trial conducted in Belgium.The trial involved 266 healthy adults, 18 to 40 years of age. The vaccinetested was produced from inactivated H5N1 virus and contains a new,proprietary adjuvant aimed at stimulating the immune system to increase theresponse to the vaccine. Trial participants received two doses of eachformulation. Four levels of antigen dose were tested, with 1.9 microgramsbeing the lowest dose.
Preliminary data also show good cross-reactivity to a more recentlycirculating H5N1 strain. Further assessment of the ability of this vaccine toprovide cross-protection to variants of the H5N1 strains is ongoing.
Sanofi pasteur has committed, in the event of a pandemic being declaredby the World Health Organization (WHO), to producing the largest possiblenumber of doses of its most advanced pandemic influenza vaccine in theshortest possible time. In order to increase its capacity, sanofi pasteurinitiated clinical trials with a novel adjuvant aimed at dramaticallyreducing the amount of antigen needed to elicit a protective immune responseto the H5N1 strain currently identified by global health authorities andexperts as a potential source for the next pandemic.
According to the WHO, the next influenza pandemic could result in 1million to 2.3 million hospitalizations and 280,000 to 650,000 deaths inindustrialized nations alone. Its impact is expected to be even moredevastating in developing countries.
With production of 170 million doses of influenza vaccine in 2006, sanofipasteur confirmed its leadership as the world's largest manufacturer ofseasonal influenza vaccine, supplying a large portion of the estimated globalproduction of about 350 million doses(1). Sanofi pasteur's Vaxigrip(R) andFluzone(R) influenza virus vaccines are licensed in over 100 countries.
Pandemic Influenza Overview
Influenza is a disease caused by a highly infectious virus that spreadseasily from person to person, primarily when an infected individual coughs orsneezes. An influenza pandemic is a global epidemic of an especially virulentvirus, newly infectious for humans, and for which there is no preexistingimmunity. This is why pandemic strains have such potential to cause severemorbidity and mortality. In an attempt to minimize the impact of a pandemic,many countries are developing national and transnational plans against apossible influenza pandemic situation.
Sanofi Pasteur and Pandemic Preparedness
Sanofi pasteur is committed to global pandemi
