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Novartis, one of the leading global pharmaceutical major, has disclosed that the swine flu vaccine from the manufacturer is ready to make its entry in Europe.
"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.
Focetria, the H1N1/A monovalent vaccine from Novartis, was approved by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on Friday.
The initial batch of vaccines has already been delivered under quarantine to European countries.
"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.
Oswald mentioned that EU will soon approve the same, after which they can kick off the vaccination process.
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.
