GSK Files Pre-Pandemic Flu Vaccine in Europe

GlaxoSmithKline’s new generation H5N1 split antigen pre-pandemic flu vaccine has been accepted for review by the Committee for Medicinal Products for Human Use (CHMP) in Europe. This vaccine utilizes GSK’s proprietary adjuvant system technology, which allows a very low amount of antigen to be used to elicit a strong seroprotective response, known as the ‘antigen-sparing’ effect.

A recent trial conducted in Belgium involving the H5N1 vaccine has shown that two very low doses of antigen (3.8µg), given 21 days apart, combined with the novel adjuvant system, enabled more than 80% of individuals to produce a high seroprotective response, a level which exceeds target criteria set by regulatory authorities for registration of flu vaccines. ‘Antigen-sparing’ allows a large number of vaccine doses to be produced for mass vaccination. Also, the extent of the immune response to the antigen, in the presence of the novel adjuvant system, is expected to give protection against variants of the H5N1 virus.

GSK also plans to file the pre-pandemic vaccine in other countries. This vaccine could also be adapted for pandemic use once the pandemic flu strain is identified. GSK has entered into active negotiations with various governments to supply pre-pandemic and/or pandemic flu vaccines.