The FINANCIAL — Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced on June 16 its commitment to donate 60 million doses of H5N1 vaccine to the World Health Organization (WHO) over 3 years for the establishment of an H5N1 vaccine global stockpile.
“The H5N1 virus is currently circulating in some of the poorest regions of the world and an outbreak
of pandemic influenza would most likely hit populations living in areas with limited access to
vaccines. This donation of H5N1 vaccine aims to address the needs of those most vulnerable
populations,” said Wayne Pisano, President and Chief Executive Officer of sanofi pasteur.
“In addition to supporting the efforts of governments, it is essential that industry collaborates with
international organizations such as WHO, the Bill and Melinda Gates Foundation and other global
health players. This is the best way to build a stockpile of vaccines for developing nations, ready to
be deployed on the ground in the event of a pandemic flu outbreak,” added Pisano.
Sanofi Pasteur’s leadership position in developing and producing influenza vaccines places the
company at the forefront of readiness against the threat of pandemic influenza. The company is
committed to addressing current and future public health needs by investing in a robust research
and development program and in an ambitious seasonal and pandemic influenza vaccine
production plan.
Each year since 2004, sanofi pasteur produced millions of doses of H5N1 avian influenza vaccine,
both in France and in the United States. In April 2007, the U.S. Food and Drug Administration
(FDA) licensed sanofi pasteur’s H5N1 vaccine, the first avian influenza vaccine for humans in the
U.S.
Sanofi Pasteur recently conducted clinical trials with a novel, proprietary adjuvant aimed at
dramatically reducing the amount of antigen needed to elicit a protective immune response to the
H5N1 strain currently identified by global health authorities and experts as a potential source for the
next pandemic. These data show the ability of this new investigational H5N1 pandemic influenza
vaccine to generate a high immune response with a very low dose of H5N1 antigen.
Sanofi Pasteur is committed to producing as many doses as possible of its most advanced vaccine
in the shortest possible timeframe should a pandemic be declared by WHO. Under such
circumstances, sanofi pasteur’s seasonal influenza vaccine facilities would globally be able to
switch to pandemic vaccine manufacturing.
Sanofi Pasteur recently completed the construction of a new influenza vaccine manufacturing
facility in the United States, incorporating the latest technology in vaccine production. This new
facility is planned to go online in 2009. Sanofi Pasteur is also on track to build a facility to
manufacture seasonal influenza vaccine in China for the local market. This vaccine manufacturing
facility is due to be operational by 2012. A new formulation and filling facility located in France is
also planned to become operational in 2009. This new state-of-the-industry facility will boost sanofi
pasteur’s filling capabilities.
With the production of 180-million doses of seasonal influenza vaccine last year, sanofi pasteur
confirmed its leadership by supplying an estimated 40 percent of the world influenza vaccine
market1.
Reference: 1. Data based on internal estimates
Pandemic Influenza Overview
Influenza is a disease caused by a highly infectious virus that spreads easily from person to person,
primarily when an infected individual coughs or sneezes. An influenza pandemic is a global
epidemic of an especially virulent virus, newly infectious for humans, and for which there is no
preexisting immunity. This is why pandemic strains have such potential to cause severe morbidity
and mortality. The H5N1 viral strain has been identified by global health authorities as being a
potential cause of a pandemic. In an attempt to minimize the impact of a pandemic, many countries
are developing national and transnational plans against a possible influenza pandemic situation.
According to the World Health Organization (WHO), there have been 383 cases of avian influenza
transmitted to humans since 2003, with 241 resulting in death.
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