Baxter Gets EU Approval for Celvapan H1N1

Baxter International, Inc. has been granted marketing authorization for Celvapan H1N1 pandemic vaccine from the European Commission. Celvapan H1N1 is the first cell culture-based and non-adjuvanted pandemic flu vaccine to receive marketing authorization in the EU.

Baxter continues to deliver vaccine to national health authorities that have agreements with the company. Initial quantities of vaccine have already been received by a number of countries, including the UK and Ireland.

Baxter is confirming the safety and immunogenicity of Celvapan H1N1 in clinical trials and will supplement the licensure post-approval with data from its ongoing clinical program. Preliminary safety data indicates the vaccine is well tolerated. The current dosing schedule calls for two 7.5 µg doses of vaccine to be given 21 days apart. The company expects the data from the trial of healthy adults to indicate whether a single dose may be possible for Celvapan H1N1. This study will also determine whether a lower dose is sufficient to induce the necessary immune response.