Chiron Corporation announced that it has won a contract from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the US National Institutes of Health (NIH), to produce an investigational vaccine designed to protect against the strain of avian influenza that recently circulated in China and the Far East. The H5N1 influenza strain resulted in more than 20 human deaths and a subsequent cull of poultry throughout the region in an effort to prevent a potential worldwide influenza pandemic.
"The avian influenza outbreaks last winter highlight the very real threat posed by pandemic influenza," said John Lambert, president of Chiron Vaccines. "As a leading influenza vaccine manufacturer, Chiron has produced vaccines designed to protect against other types of avian influenza, including the strain that resulted in several deaths in Hong Kong in 1997. Subsequent clinical testing demonstrated that it should be possible to protect against this lethal Hong Kong strain. Our current work with the NIAID builds on this experience, further developing our ability to produce vaccines with the potential to protect society against a pandemic."
Under the terms of the contract, Chiron will produce 8,000 doses of the investigational H5N1 vaccine for the NIAID, which will conduct clinical studies exploring the safety profile and immunogenicity of two different doses. Chiron will produce the vaccine at its Liverpool manufacturing facility, using the production process used for its marketed influenza vaccine, Fluvirin. Chiron will make the vaccine, using reverse genetics, from seed virus provided via the usual route for commercial products.
"While we do not know when, we do know we will experience another pandemic, and it will have the potential to kill a great number of people," said Walter A. Orenstein, associate director of the Emory Vaccine Center in Atlanta, Georgia. "Detailed planning is essential to ensure we are ready to face such a threat, and clinical studies with this H5N1 vaccine are critical in furthering our understanding of how to protect against it. This type of public-private partnership between government and industry is crucial to advancing our pandemic preparedness capabilities."
Pandemic influenza occurred three times in the last century, with the Spanish flu of 1918-19 killing between 20 million and 50 million people. Pandemic influenza occurs when a new virus emerges to which people do not have immunity, causing a worldwide outbreak of disease. Avian influenza, or "bird flu," does not normally infect humans, but there have been several examples in recent years of transmission to people, leading to fears of a strain with the potential to result in a pandemic. The World Health Organization estimates that the recent avian influenza outbreak in Southeast Asia resulted in 34 human cases, with 23 fatalities, and more than 100 million bird deaths either from the disease or the subsequent cull.