Baxter International Inc. (NYSE:BAX) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its “positive opinion” for CELVAPAN H1N1 pandemic vaccine using Baxter’s Vero cell technology. This positive opinion confirms the acceptability of Baxter’s regulatory submission to obtain final marketing authorization and licensure of the product.
CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted vaccine to receive a positive opinion in the European Union. Initial quantities of vaccine have already been delivered to a number of countries, including the UK and Ireland, for use in their national vaccination programs, and are awaiting product release subject to final marketing authorization being granted by the European Commission.
Presently, Baxter is confirming the safety and immunogenicity of CELVAPAN H1N1 in clinical trials. 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 with CELVAPAN in 9,000 people of different age groups, including children.
Preliminary safety data in adults and the elderly indicate that the vaccine is well tolerated in these age groups. 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 are due later this month. 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.
"We are pleased that the regulatory submission and the preliminary clinical trial data uphold the extensive work done by Baxter and the support received from key Ministries of Health in developing a pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “We are looking forward to analyzing the immunogenicity data for our cell culture-derived, non-adjuvanted vaccine to assess the potential of a one dose regimen.”