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BAXTER RECEIVES EMEA POSITIVE OPINION FOR CELVAPAN H1N1 PANDEMIC FLU VACCINE<br />
VACCINE Page 2<br />
initiate national vaccination programs using CELVAPAN H1N1, <strong>Baxter</strong> will also conduct<br />
a large-scale observational study with CELVAPAN in 9,000 people of different age<br />
groups, including children.<br />
Preliminary safety data in adults and the elderly indicate that the vaccine is well<br />
tolerated in these age groups. The observed systemic and local reactions are similar to<br />
those generally experienced after vaccination with licensed seasonal influenza<br />
vaccines. Immunogenicity data from the first vaccination in adults are due later this<br />
month. The current dosing schedule, as specified in the EMEA mock-up licensure for<br />
CELVAPAN using another virus strain, calls for two 7.5 µg doses of vaccine to be given<br />
21 days apart. <strong>Baxter</strong> expects the data from the trial of healthy adults to indicate<br />
whether a single dose may be possible for CELVAPAN H1N1. This study will also<br />
determine whether a lower dose, 3.75µg, is sufficient to induce the necessary immune<br />
response.<br />
"We are pleased that the regulatory submission and the preliminary clinical trial<br />
data uphold the extensive work done by <strong>Baxter</strong> and the support received from key<br />
Ministries of Health in developing a pandemic vaccine,” said Hartmut J. Ehrlich, M.D.,<br />
vice president of global research and development for <strong>Baxter</strong> BioScience. “We are<br />
looking forward to analyzing the immunogenicity data for our cell culture-derived, non-<br />
adjuvanted vaccine to assess the potential of a one dose regimen.”<br />
ABOUT BAXTER’S PANDEMIC VACCINE DEVELOPMENT<br />
Earlier this year, the EMEA granted mock-up licensure for CELVAPAN using a<br />
different strain with pandemic potential, which was tested in five completed clinical trials<br />
worldwide in more than 1,300 people. In addition, more than 3,500 people have been<br />
vaccinated using the same strain during an ongoing Phase III study. Mock-up licensure<br />
is a regulatory pathway for pandemic vaccines that was created by the EMEA in 2004.<br />
This pathway allows for the development, evaluation and licensure of a company’s