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Viral Flu, © 2009 Novartis AG

Basel and Geneva, Switzerland (GenevaLunch) – Swiss drugs maker Novartis said 5 August it had begun trials of a swine flu vaccine on humans in Germany, the US  and the UK. If the trials are successful, the vaccine could be approved by regulators using a fast-track approvals process in Europe and the US. Large-scale production would then be ramped up in time for the northern hemisphere’s flu season in autumn.

All major drugs manufacturers are racing to finish human trials in order to begin production of a vaccine. Australian drugs manufacturers announced last month that they had begun human trials.

Fast track procedures take into account strain changes

The WHO (World Health Organization) says that fast-track procedures worked out by regulators in many countries are based on existing procedures for approving seasonal flu vaccines, which take into account small changes in the flu virus, so-called “strain changes.”

A strain change vaccine is approved according to tests not quite as stringent as those for a completely new vaccine. WHO points out that flu vaccines have been “used for more than 60 years and have an established record of safety in all age groups.” The organization in a 6 August press release was addressing fears that these vaccines might not be safe when put on the market.

Novartis says it has contracts with the US government worth $979 million for bulk shipments of A/H1N1 vaccine, and similar deals with France, the Netherlands and Germany. Plans are to ship a vaccine by the last quarter of 2009 and into 2010.

Background: “Clinical trials of A/H1N1 flu vaccine on humans in Australia and US“, 23 July 2009, GenevaLunch

Related: Washington Post, National Institute of Allergies and Infectious Diseases, NIH, US government