Influenza A(H1N1) information center
July 24, 2009
At Novartis, we are making good progress in our efforts to rapidly produce and commercialize a vaccine against the H1N1 virus. We started clinical trials with the H1N1 vaccine in July.
Novartis has started large-scale antigen production at all flu vaccines manufacturing sites in Europe, using both traditional egg-based manufacturing as well as its faster cell-based vaccine production capacity to maximize the potential vaccine supply. Using cell-culture technology, first batches were successfully produced from both the wild virus strain and the “reassortant seed” modified virus recommended by the WHO and health authorities. As reported by WHO, current yields from the reassortant strain are lower than expected. We are working diligently to make adjustments to improve the yields currently observed.
Novartis has secured several orders for H1N1 vaccines amid discussions with more than 35 governments. The US government has now awarded Novartis two contracts totaling USD 979 million for future purchase of H1N1 bulk vaccine and the Group’s proprietary MF59 adjuvant, while contracts have also been signed with other countries including France, the Netherlands and Switzerland.
Pending approval from Regulatory authorities and evolution of the yields, we expect deliveries to begin to government customers in the fourth quarter and continue into 2010.
June 12, 2009
Novartis has successfully completed production of the first batch of the Influenza A(H1N1) vaccine using the wild virus strain. We are also close to completing manufacture of the first vaccine batch using the reassortant seed — the modified virus provided by the US Centers for Disease Control and Prevention (CDC) to vaccine manufacturers in May — at our state of the art cell-culture production facility in Marburg, Germany. Based on the success with the wild type strain production, Novartis expects to be able to achieve rapid manufacture and scale up of A(H1N1) vaccine production using cell-based and the reassortant seed.
We are using both cell-based vaccine production in Marburg, which is faster, and our egg-based manufacturing in Liverpool, UK and Siena, Italy to increase the likelihood of the greatest possible supply.
Novartis continues to work alongside the World Health Organization (WHO), US CDC, Pan American Health Organizations (PAHO), and other government agencies worldwide, as well as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on developing a strong and effective response to the A(H1N1) flu pandemic.
The health and welfare of people, including Novartis associates and their families, is of paramount importance. Novartis, in line with its efforts for pandemic preparedness and ensuring business continuity, has put in place actions to ensure the protection of its associates in the affected areas.
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Current WHO phase of pandemic alert: LEVEL 6
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