Chiron to Produce Avian Influenza Vaccine for National Institutes of Health Studies

EMERYVILLE, Calif. -- Chiron Corporation today announced that it has won a contract from the National

Institute of Allergy and Infectious Diseases (NIAID), a part of the

U.S. 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. The seed virus for preparation of the vaccine will be

produced using reverse genetics and will be provided to Chiron 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, MD, associate director of the Emory Vaccine Center

in Atlanta. "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.

Source: Chiron Corporation