Following discussions which started a few months ago, sanofi pasteur, the vaccines business of the sanofi-aventis Group, has entered into an agreement with the French Ministry of Health to produce pre-pandemic vaccine in 2005 against the H5N1 influenza virus strain, the so-called avian strain. This will create a stockpile of 1,400,000 doses of vaccine. Scientists believe the H5N1 strain could become the cause of a global influenza pandemic. The agreement also commits the company to being ready to provide enough vaccine for 28 million people in the event of a pandemic being declared, once the actual virus strain responsible has been identified.
According to the terms of the contract, in 2005, sanofi pasteur is to supply in bulk concentrate form the H5N1 vaccine produced in its Val de Reuil, France, facility. Formulation and filling of the vaccine can then be carried out, at any time, at the request of the French authorities.
Trials with H5N1 vaccine have been launched at three sites in France using the clinical lots produced by sanofi pasteur during 2005. The aim of the trials was to evaluate the safety and immunogenicity of the vaccine and to determine its optimal formulation, especially concerning the adjuvant. The results should be known by the end of 2005. They will be used in the preparation of a mock-up registration file for submission to the European Medicines Agency (EMEA) so that registration of the actual pandemic vaccine can be speeded up in case of pandemia, claims a company release.
The sanofi pasteur contract with the French government, which will be carried out in collaboration with sanofi pasteur MSD, is another major step by the company in its support of efforts to prepare the world for the possibility of an influenza pandemic.
Sanofi pasteur is investing in a major expansion of its influenza vaccine production capacity in the USA, and also of its vaccine production capacity in France (Val de Reuil facility).