Novartis Begins Shipment of Seasonal Influenza Vaccines to U.S. Market

Novartis announces that it has begun shipment of its seasonal influenza vaccines to customers in the U.S. market for the 2013-2014 season. Novartis plans to ship a minimum of 30 million doses of its influenza vaccines to the U.S. market, including Fluvirin (Influenza Virus Vaccine), approved for use in people 4 years of age and older, and Flucelvax (Influenza Virus Vaccine), approved for use in adults 18 years of age and older. In clinical studies, both vaccines demonstrated safety and were shown to help protect against WHO-identified strains of the influenza virus.

The Centers for Disease Control and Prevention (CDC) recommends routine seasonal influenza vaccination for all individuals 6 months of age and older. In addition, the CDC advises that it is especially important for certain high-risk groups to receive an influenza vaccine each season, including: people over the age of 50; children under the age of 5; people with chronic illnesses; people with immunosuppression; and residents of nursing homes and other long-term care facilities.

"Last year's flu season, which peaked early and was intense, is a significant reminder of the importance of annual seasonal flu vaccination," says Dr. William Schaffner, professor of medicine and preventive medicine at Vanderbilt University, Nashville, Tennessee. "The CDC recommends annual influenza vaccination for all adults, and getting a flu vaccine is an important step in protecting one's health."

Novartis plans to complete the majority of shipments of Fluvirin and Flucelvax by October, in advance of the peak of influenza season. The Novartis portfolio of influenza vaccines helps to ensure diversity of supply to help meet demand and offers providers and consumers options for flu vaccination.

"Each year, Novartis is proud to help meet a significant public health need by providing its seasonal flu vaccines to enable healthcare providers and pharmacists to help protect individuals and families from the flu," says Brent MacGregor, president of U.S. Vaccines and head of Region North America. "We are pleased to offer a portfolio of flu vaccines that includes Flucelvax, which reflects how we are rethinking flu vaccination with a new approach to vaccine production and which offers a choice to consumers."

Flucelvax is manufactured using innovative cell-culture technology, a process that differs from the traditional influenza vaccine manufacturing process, which occurs in chicken eggs. Cell-culture technology offers several potential benefits, including flexibility in the manufacturing process, creating potential for rapid scalability in the event of a pandemic, and an alternative flu vaccine supply. Flucelvax does not contain any preservatives or antibiotics.

About Seasonal Influenza
Seasonal influenza is a highly communicable, acute viral infection that predominantly attacks the respiratory tract and sometimes the lungs. It can cause mild to severe illness and can sometimes lead to complications and death3.

The number of people in the US who die every year from influenza and its complications could be comparable to the more than 40,000 people in the US who die each year from breast cancer, and to about half of the estimated 73,000 people who die annually of diabetes and its complications each year in the US4,5.

For the 2013-2014 season, Fluvirin and Flucelvax contain antigens that target three influenza virus strains identified by World Health Organization (WHO) experts as likely to dominate circulation this winter.

For Fluvirin, these include:
 A/Christchurch/16/2010, NIB-74 (H1N1) (an A/California/7/2009-like virus)
A/Texas/50/2012, NYMC X-223A (H3N2) (an A/Victoria/361/2011-like virus)

For Flucelvax, these include:
 A/Brisbane/10/2010 (H1N1) (an A/California/7/2009-like virus)
A/Texas/50/2012, NYMC X-223A (H3N2) (an A/Victoria/361/2011-like virus)