The manufacturing process is very complex

I here we produce now 1 million doses of vaccine per week. "Andrin Oswald, the Director of the vaccines division of Novartis, is proud to show its plant near Siena in Tuscany. Since a few days, this unit turns full and almost non-stop manufactures vaccines against influenza A (H1N1) virus. After the warning launched by who in the spring, the Basel laboratory hired nearly a thousand people and injected $ 100 million into this unit. "The production capacity has been tripled." "From here to the end of the year, we will make approximately 75 million doses, mainly intended for the Governments of European countries", says the Swiss leader.

Part of this production is intended for the France (18 million doses) and the first clinical trials have been satisfactory. "A single injection will probably suffice and immunity is acquired after ten days," said Andrin Oswald. On the side of bad news, low industrial performance concern from the outset has been confirmed: "this strain produces about 40 less than the virus of influenza that we usually use."Given these parameters, the Novartis H1N1 vaccine will be sold between 7 and 10 euros for the dose.

The manufacturing process is very complex. It's to grow viruses in very secure industrial conditions. After the strain selection initial (by who), the whole virus are introduced in eggs of hen fertilized and maintained at proper temperature. These tanks will become real fermenters where viruses proliferate at very high speed. The néovirus are then separated by centrifugation before be inactivated. In fact, only the outer shell of the pathogen proteins are retained. These particles, true identity card of the virus, are integrated into a solution that becomes the active principle of future vaccine. After injection into the body, these surface proteins are detected by the immune system and trigger the production of specific antibodies. Influenza A vaccine is a monovalent (it does protect against the H1N1 flu). By comparison, the seasonal flu vaccine (manufactured) is a combination of three strains in one light bulb.

Cell culture

These vaccines are sometimes doped by a lipid which strengthens their action. "We are using squalene, that we use for 12 years in our influenza vaccine." "More than 40 million doses have been produced with this adjuvant", said Dr. Oswald. This additive is at the origin of many polemics and is not unanimous. "The United States appear to move towards a solution without adjuvant," reveals Andrin Oswald. With this production, Novartis to band in a limited community controlled by four heavy weight: Sanofi-Pasteur, GSK, Merck and Wyeth (read "Les Echos" from September 16). By purchasing Chiron (in 2006), the Swiss became the world's fifth largest. He has two other plants in Europe (Liverpool England) and Marburg in Germany.

The new unit under construction in the United States uses a technology that mobilizes all producers: cell culture. Long, industrialists are seeking to get rid of culture on eggs, a real puzzle medical and industrial. This method requires railway logistics to supply the production with a raw material vulnerable sites. In addition, the products of this sector still have traces of egg sources of allergies in children. Cell culture free of these problems. Viruses are produced by genetically modified animal cells. "Eventually, this will be the mode of manufacture of base", predicted Andrin Oswald. After six months of tensions, the expert draws the lessons of the crisis H1N1 with a background of concern. "We are in a situation of very tense production." If the pandemic was more severe, we would be in a very worrying situation of shortage of vaccines at the global level.