Swine flu vaccine ready, enters Europe
By IANSFriday, September 25, 2009
NEW DELHI - Global pharma major Novartis Friday announced it is ready with a swine flu vaccine and has started first deliveries to governments in Europe, giving hopes to people in many parts of the world.
Novartis has already started first deliveries of pandemic vaccines under quarantine to governments in Europe, despite the initially low yields with the current production seed strain provided by the World Health Organisation (WHO). A new seed strain could provide higher volumes, the company said in a statement issued in Switzerland.
The company announced that Focetria, the Novartis Influenza A(H1N1) 2009 monovalent vaccine, Friday received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).
The company has started first deliveries of pandemic vaccines under quarantine to European countries, which means the vaccine is now ready with the governments but only after getting the formal approval the governments can start vaccination.
The positive opinion clears the way for European Union approval in all 27 member states as well as in Iceland and Norway. Today’s announcement marks a significant milestone in bringing a pandemic vaccine to market in Europe, the company added.
“Only three months after the declaration of the pandemic by the WHO, Novartis was able to ship the first batches of our pandemic vaccine under quarantine to governments in Europe pending EU approval,” said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.
This CHMP positive opinion paves the way for EU approval, which will allow governments to begin their vaccination campaigns with the goal of reaching more patients before the rapidly spreading virus reaches them, Oswald added.
The pharma major, however, did not give details of the number of doses it has despatched or the countries which have received the first deliveries.
More than 150 countries have been affected by the new millennium’s first pandemic. It has taken hundreds of lives across the globe.
In India, the virus has killed 286 people and infected more than 9,200 people till Sep 25.