Chiron Corporation has received a $62.5 million contract to supply the US government with pre-pandemic influenza vaccine for a stockpile to protect against the H5N1 avian influenza virus strain. Under the agreement with the Department of Health and Human Services (HHS), Chiron will provide a bulk stockpile of H5N1 influenza vaccine, which the company will produce at its Liverpool manufacturing facility using the US-licensed commercial-scale manufacturing process. Production of the H5N1 stockpile vaccine under this agreement will not affect production of Chiron's annual Fluvirin influenza virus vaccine.
"Chiron commends the US government's comprehensive approach to pandemic preparedness. We have engaged in discussions with a number of governments around the world on a range of pandemic measures, including vaccine stockpiling and advance purchase contracts. Avian influenza knows no boundaries, and public-private partnerships are essential to address the threat it poses. As a leading influenza vaccine manufacturer, we are pleased to bring the capabilities of all of our influenza production facilities to this global effort," said Dan Soland, president of Chiron Vaccines.
The stockpile vaccine, which Chiron will provide to HHS in 2006, is based on an inactivated influenza strain similar to the H5N1 avian subtype that has circulated throughout Southeast Asia and more recently in Eastern Europe. H5N1 is one of a number of avian influenza viruses that do not usually infect humans. However, if the virus acquired the ability to readily transmit from person to person, it could result in a global outbreak of influenza to which people have no natural immunity, commonly called a pandemic, claims a company release.
With pandemic vaccine research ongoing, providing the stockpile vaccine in bulk will allow HHS to determine final dose and formulation, including potentially adding an adjuvant, based on the most current data available at the time of use. The stockpile vaccine contributes to the US national strategic stockpile, which HHS is building to contain enough avian influenza vaccine for 20 million people and enough antiviral medication for another 20 million people. As part of its comprehensive approach to pandemic preparedness, HHS has also voiced support for improved vaccine production methods and dose-sparing vaccine approaches such as the use of adjuvants.
"Chiron has invested in research and development to improve global capabilities to combat both annual and pandemic influenza. Stockpiling is an important primary step toward readiness for this potential threat. We expect that our work with adjuvants and, longer-term, flu cell culture, may also contribute to efforts to prevent a pandemic," said Rino Rappuoli, chief scientific officer of Chiron and head of research for Chiron Vaccines.
The release further informs that Chiron has studied H5N1 since the avian influenza virus first emerged in Hong Kong in 1997. In addition to its stockpile contract, Chiron will provide an H5N1 avian influenza vaccine candidate for a study by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) under HHS, later this year. The NIAID/NIH has also completed a study of Chiron's H9N2 avian influenza vaccine candidate, including the MF59 adjuvant, designed to enhance vaccine effectiveness, and data will be forthcoming. H9N2, like H5N1, is a potential pandemic influenza strain, which caused serious illness in three people in Hong Kong in 1999 and 2003.
Pandemic influenza occurs when a new virus emerges that is easily transmitted among humans and causes serious illness. In this situation, the virus can result in a worldwide outbreak of disease, or pandemic. Pandemic influenza occurred three times in the last century, with the 1918 outbreak killing at least 40 million people, with a mortality rate of approximately 2.5 percent in the United States.