Baxter receives EC approval for Celvapan H1N1 pandemic flu vaccine
14 October 2009
Baxter International Inc. (NYSE: BAX) has announced 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.
About Baxter's pandemic vaccine development
Earlier this year, the EMEA granted mock-up licensure for Celvapan using a different strain with pandemic potential, which was tested in five completed clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated using the same strain during an ongoing Phase III study.
Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004. This pathway allows for the development, evaluation and licensure of a company’s pandemic candidate vaccine using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain.
Baxter received the H1N1 strain for testing and evaluation from the US Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics in the company’s proprietary Vero cell culture technology.
Baxter initiated commercial production in early June, and made its first commercial product within 12 weeks of receipt of the virus. The company produces bulk Celvapan H1N1 vaccine at its large-scale commercial facility in Bohumil, Czech Republic, and then sends the vaccine to Vienna, Austria for the final formulation, fill and finish before distribution. Baxter completed production of the first batches of Celvapan H1N1 vaccine in late July and initiated its first delivery within two weeks. The company continues to deliver vaccine on an ongoing basis to national public health authorities.
Baxter initiated its license application for Celvapan H1N1 in July based on the EMEA published guidelines for pandemic vaccine marketing authorization. The company conducted rigorous testing of the H1N1 based vaccine and submitted additional data for vaccine development, product quality and manufacturing processes specific to that strain. Other non-EU countries may choose to evaluate the company’s EMEA submission and licensure as the basis for their national health authority’s authorization for use of the vaccine.
The company is conducting two randomized trials in 400 healthy adults age 18 and over and in 400 children and adolescents to supplement the licensure post-approval with appropriate clinical data. These trials are evaluating the safety and immunogenicity of the vaccine at dose levels of 7.5µg and 3.75µg. Once countries initiate national vaccination programs using Celvapan H1N1, Baxter will also conduct a large-scale observational study in 9,000 people of different age groups, including children.
More information on Celvapan H1N1 clinical trials is available at http://www.clinicaltrials.gov/ct2/results?term=baxter+h1n1
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