Baxter International Inc. (BAX) announced that the European Medicines Agency (EMEA) opined positively for Baxter’s CELVAPAN H1N1 pandemic vaccine, commonly known as the Swine Flu vaccine.
This is a boost for Baxter’s regulatory submission to obtain final marketing authorization and licensure of the product in the European Union. Baxter has already delivered limited quantities of H1N1 in a few countries, such as the UK and Ireland , as part of their national vaccination programs.
Presently, Baxter is conducting two clinical trials to confirm the safety and immunogenicity of CELVAPAN H1N1. These trials encompass 400 healthy adults who are 18 years and above, besides 400 children and adolescents. The safety and immunogenicity of CELVAPAN H1N1 in these trials are conducted at dose levels of 7.5µg and 3.75µg, respectively. Baxter also plans to conduct a large-scale study of CELVAPAN in 9,000 people of different age groups including children.
Preliminary safety data in adults for 7.5µg doses of vaccine indicated that the vaccine was well tolerated in these age groups. The reactions were also similar to seasonal influenza vaccines. Two 7.5µg doses of vaccine were administered in a span of 21 days. Immunogenicity data from this study are due later this month. This will indicate whether a single dose of vaccine is sufficient to induce the necessary immune response.
Another study for 3.75µg doses of vaccine will indicate whether a lower dose is sufficient to induce the necessary immune response or not.
Baxter is a leading global medical products and services company that develops, manufactures and markets products to save the lives of millions of people affected by hemophilia, kidney diseases, infectious diseases, etc. Baxter’s life-sustaining product portfolio is a hedge against the current economic turmoil. The company’s main competitors include Becton, Dickinson and Co. (BDX) and Johnson & Johnson (JNJ).
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