Baxter International Inc. (NYSE: BAX) today confirmed that the European Commission (EC) has granted marketing authorization for CELVAPAN H1N1 pandemic vaccine using Baxter’s Vero cell technology. CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted pandemic influenza vaccine to receive marketing authorization in the European Union.
Baxter continues to deliver vaccine to national public 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, for use in their national vaccination programs.
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 trial program. Preliminary safety data from CELVAPAN H1N1 clinical trials in adults age 18 and older indicate the vaccine is well tolerated. The observed systemic and local reactions are similar to those generally experienced after vaccination with licensed seasonal influenza vaccines.
Immunogenicity data from the first vaccination in adults will be submitted to the European Medicines Agency within days. The current dosing schedule, as specified in the EMEA mock-up licensure for CELVAPAN using another virus strain, calls for two 7.5 µg doses of vaccine to be given 21 days apart. Baxter 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, 3.75µg, is sufficient to induce the necessary immune response.