EC grants marketing authorization for Baxter's VEPACEL to treat influenza A

Baxter International Inc. (NYSE:BAX) announced today that the European Commission (EC) has granted marketing authorization for VEPACEL in all European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway.

VEPACEL is a pre-pandemic influenza vaccine indicated for active immunization in adults 18 years and older (including immunocompromised and chronically ill patients) against the H5N1 subtype of influenza A (A/Vietnam1203/2004), commonly known as bird or avian flu. Pre-pandemic vaccination provides a level of protection against an emerging highly pathogenic influenza strain prior to an officially-declared pandemic. VEPACEL is manufactured using Baxter's proprietary advanced Vero cell technology.

"The approval of VEPACEL demonstrates Baxter's commitment to the production of pandemic and pre-pandemic vaccines to protect vulnerable individuals from the H5N1 virus," said Prof. Hartmut J. Ehrlich, M.D., vice president of global research and development in Baxter's BioScience business. "VEPACEL offers cross-protection against a broad range of H5N1 strains. It also results in a sustained immunological memory response, meaning that those who receive a 'booster' with a different pandemic strain vaccine will gain a rapid protective response to the pandemic virus."

VEPACEL is composed of purified, inactivated whole influenza virion, licensed as a suspension for injection containing 7.5 μg haemagglutinin (HA) antigen per 0.5 ml dose. VEPACEL clinical studies involved more than 4,700 people aged 18 to over 60 years. VEPACEL was well-tolerated and adverse events were mild and transient, the most common of which were pain at the injection site, headache and fatigue.

VEPACEL has the potential to generate a broader immune response than conventional egg-derived vaccines due to its use of Vero cell technology, which allows for use of the natural influenza virus (identical in protein composition to the virus circulating in nature) in vaccine production. Unlike traditional egg-grown influenza vaccines, eggs are not used in the VEPACEL manufacturing process. This is of particular significance for a vaccine protecting against an avian influenza strain such as H5N1 where the bird flocks needed for egg-based vaccine production may be adversely affected by the virus. VEPACEL is therefore free of egg protein, antibiotics and preservatives, making it also suitable for those with egg or antibiotic allergies.

Source: Baxter International Inc.