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Published on 21 December 2009

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All three Novartis A(H1N1) 2009 influenza vaccines prequalified by WHO


Novartis announced today that the World Health Organisation (WHO) has granted prequalification for all three of its influenza A(H1N1) 2009 monovalent vaccines for supply to United Nations (UN) agencies: the cell culture-based and MF59 adjuvanted vaccine Celtura, the egg-based and MF59 adjuvanted vaccine Focetria as well as the egg-based A(H1N1) vaccine manufactured using the seasonal Fluvirin platform. In addition to granting prequalified status for Novartis’ three influenza A(H1N1) 2009 vaccines, WHO has also granted prequalification for the company’s trivalent seasonal Fluvirin vaccine.

WHO prequalification facilitates purchasing through UN agencies and thus enhances access for developing world countries to Novartis A(H1N1) 2009 vaccines that meet unified standards of quality and safety. Novartis has worked closely with WHO under WHO’s expedited procedure for evaluating pandemic influenza A(H1N1) 2009 vaccines to ensure rapid prequalification of its A(H1N1) 2009 influenza vaccines.

“With WHO prequalification for all three of our A(H1N1) 2009 vaccines, we have expanded our commitment to contribute to the prevention of A(H1N1) 2009 influenza in all countries around the world,” said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics.

Prequalification of the adjuvanted vaccines is an important milestone to increase vaccine supply due to the proven antigen and dose sparing potential of the MF59 adjuvant. It is the only oil-in-water adjuvant supported by more than 12 years of post-marketing safety data that includes commercial distribution of more than 45 million doses. The adjuvant has also been studied in randomised clinical trials and observational studies involving 124,000 individuals including children, adults, and elderly; and was first licensed in the seasonal influenza vaccine Fluad in Italy in 1997. Fluad is currently licensed in Europe for use in individuals 65 years of age and older.

Novartis recognises the public health need for better access to medicines and vaccines in developing countries. Novartis is working closely with developing countries and international health agencies to find sustainable solutions for effective distribution of essential medicines for diseases such as malaria, meningitis, tuberculosis and leprosy.


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