tetano
Editor, Senior Moderator
The European Commission (EC) has granted marketing authorization for Baxter International Inc's 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, MD, 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 ?g haemagglutinin (HA) antigen per 0.5 ml dose. Its 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.
http://pharmabiz.com/NewsDetails.aspx?aid=67841&sid=2
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, MD, 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 ?g haemagglutinin (HA) antigen per 0.5 ml dose. Its 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.
http://pharmabiz.com/NewsDetails.aspx?aid=67841&sid=2