The European Medicines Agency has started to receive and review data on H1N1 pandemic vaccines.
The Committee for Medicinal Products for Human Use (CHMP) is committed to fast-tracking the review of data as vaccine manufacturers make them available.
Given the public health threat posed by the current pandemic, the Agency’s goal is to ensure that data are reviewed as early as possible, before the beginning of the Northern hemisphere flu season, expected in September.
The CHMP is currently reviewing data relating to manufacture of vaccines. The results of additional clinical trials in adults and children will be reviewed in the coming months as they become available. Approval of the H1N1 vaccine is expected to be given after satisfactory review of these data.
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.
Four ‘mock-up’ vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the EU, based on earlier data generated with the H5N1 virus strain (which is similar to H1N1), tested in 8,000 subjects.
These vaccines were developed in the knowledge that the virus strain would be changed to include the strain causing the pandemic. Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain should not substantially affect the safety or level of protection offered.
In addition to the mock-up vaccines, a number of other pandemic influenza vaccines are currently under development, and data from GSK and Sanofi Pasteur are also being assessed by the CHMP.