Pandemic Vaccines: European Market Update

Four ‘mock-up’ vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the European Union based on earlier data generated with the H5N1 virus strain, which is similar to H1N1. These vaccines were developed in the knowledge that the virus strain would be changed in the event of a declared pandemic, to include the strain causing the pandemic. Altogether, they have been tested in more than 8,000 subjects. Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine, as will apply with the change from H5N1 to H1N1 in the mock-up vaccines, should not substantially affect the safety or level of protection offered.

Approval of the H1N1 vaccine is expected to be given after satisfactory review of these data. Clinical trials with the H1N1 strain are currently being initiated or are ongoing. Initial results on the efficacy, immunogenicity and safety of the vaccine from these trials are expected from September 2009 onwards, and will also be reviewed as soon as they become available.