Novartis announced the delivery and release of its first shipments of Fluvirin influenza virus vaccine to the United States for the 2006-2007 influenza season, with continued shipments expected to follow through the end of the year.

"Ensuring a reliable and safe supply of Fluvirin for the United States is a top priority for Novartis Vaccines, and it is very rewarding to have been able to provide products early in the vaccination season to help jump-start immunizations. We plan to maintain a continuous supply during the vaccination season," said Joerg Reinhardt, CEO of Novartis Vaccines and Diagnostics.

"A dependable flu vaccine supply is critical for public health authorities to increase vaccination rates aimed at protecting more people from the threat of seasonal influenza. We intend to continue providing leadership and innovation in influenza vaccines through both our traditional flu vaccine operations as well as flu cell culture vaccines in development," Reinhardt said.

The US Food and Drug Administration's (FDA) Centre for Biologics Evaluation and Research (CBER) released in early August the first lots of Fluvirin vaccine, positioning it to become the first trivalent inactivated influenza vaccine (TIV), or "flu shot," available this year. The lots delivered and released to distributors this week correspond to more than one million doses of Fluvirin vaccine.

Novartis Vaccines intends to deliver the majority of its Fluvirin vaccine production by the end of October, with additional shipments expected through the end of 2006.

"The recently expanded vaccination recommendations highlight the importance of getting vaccinated prior to - and even at the onset - of the flu season to help reduce transmission of influenza to those who are most vulnerable," said John Vavricka, head of North America for Novartis Vaccines.

"Annual immunization against the flu is the best way to protect individuals, their families and those with whom they have contact from influenza and to reduce the toll in mortality, suffering, and lost productivity. We are hopeful that a robust vaccine supply this season will lead to improved vaccination rates, particularly for caregivers of young children as well as healthcare providers and those who come in contact with people in high-risk groups," Vavricka said.

Influenza vaccination is the most effective way to prevent influenza. Although the flu season can begin earlier, it usually starts in December, peaks in January or February, and continues through March. According to the US Centres for Disease Control and Prevention (CDC), while October and November are traditionally the primary vaccination months, vaccination in December or later is still recommended for those who are not vaccinated earlier. Influenza vaccination not only helps to decrease the risk of influenza and its complications for the vaccine recipient but can also reduce the risk of the virus spreading to those who come in contact with vaccinated people.

The Advisory Committee on Immunization Practices (ACIP), an advisory body of the CDC's National Immunization Program (NIP), issued updated recommendations for influenza vaccination in July 2006 calling for vaccination of the following groups:

People at high risk for influenza-related complications and severe disease, including: Children age 6-59 months; Pregnant women; People age 50 years or older; People of any age with certain chronic medical conditions

People who live with or care for people in the high-risk groups listed above, including: People in households who have frequent contact with people at high risk and who can transmit influenza to these people; Healthcare workers

Fluvirin vaccine is not indicated for children younger than age 4.

In an average year in the United States, influenza causes more than 200,000 hospitalizations and kills approximately 36,000 people, primarily in the over-65 population. Together, influenza and pneumonia are the seventh leading cause of death in the country, killing more people than any other infectious diseases. The annual direct medical costs of influenza are estimated at USD 3 billion to USD 5 billion. Total direct and indirect costs, including lost work days, of a severe flu epidemic could be as high as USD 12 billion to USD 14 billion.

According to the recent announcement by the European Vaccines Manufacturers (EVM), production of influenza vaccines for the 2006-2007 will be delayed due to low yields associated with the new H3N2 strains provided by the World Health Organization (WHO). The delays have affected the manufacturing campaigns for all European influenza vaccine producers. Deliveries in Europe are expected to begin in September and October, with the bulk of vaccines expected to become available later in the traditional vaccination season.