GSK FILES PREPANDEMIC FLU VACCINE WITH EMEA

GlaxoSmithKline (GSK) announced that its application for a new H5N1 split-antigen prepandemic influenza vaccine has been accepted for review by the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA). The vaccine uses GSK's proprietary adjuvant technology that allows a very low amount of antigen to be used to elicit a strong seroprotective response.

In a recent pivotal clinical trial carried out in Belgium involving the new generation H5N1 influenza vaccine, it was shown that two very low doses of antigen (3.8 micrograms), given 21 days apart and combined with the novel adjuvant system, enabled more than 80 percent of individuals to produce high seroprotective responses, at a level exceeding target criteria set by regulatory authorities for registration of influenza vaccines. The antigen-sparing phenomenon permits a large number of vaccine doses to be produced, according to the company. Furthermore, the magnitude of the immune response to the antigen, in the presence of the novel adjuvant system, is also expected to give protection against variants of the H5N1 virus.

"I believe the rapidity with which immunogenicity and safety data has been generated resulting in this filing pays tribute to our ongoing commitment to provide, in as short a time frame as possible, credible options against the threat of an influenza pandemic," Jean Stéphenne, president of GSK Biologicals, said. "As our new-generation prepandemic influenza vaccine is also believed to have the potential to offer a cross-protective response, the vaccine could be used as part of a proactive prepandemic vaccination campaign."

The British drugmaker is also planning to submit applications for the prepandemic vaccine in other countries. This vaccine could also be adapted for pandemic use once the causative influenza pandemic strain is identified. GSK has already entered into active negotiations with various governments to supply prepandemic and/or pandemic influenza vaccines.