Are adjuvanted influenza vaccines safe for use?
The adjuvant used by GSK has been tested in approximately 45,000 people around the world and has been evaluated by Health Canada and other regulatory authorities as part of the review of the H5N1 vaccine in the pre-pandemic period. No significant safety concerns regarding the use of the adjuvanted vaccine were detected. In June 2009, the WHO held consultations on the safety of adjuvanted influenza vaccines to review and discuss known and theoretical safety concerns and prospective vaccine safety evaluation. The outcome of the WHO consultation was that no significant safety concerns or barriers to evaluating or using adjuvanted vaccines for the current H1N1 virus were raised. Clinical studies have been designed to study the risks and benefits of using both adjuvanted and unadjuvanted vaccine against the H1N1 flu virus, and Health Canada and the Public Health Agency of Canada are working closely with other national agencies to implement appropriate post-market monitoring.
