Novartis announced today interim results from a Phase 1 clinical trial with its proprietary cell culture vaccine for the H7N9 avian influenza virus involving 400 healthy volunteers (18-64 years of age). The data shows 85% of subjects achieved a protective immune response after two doses of the 15 ug MF59 adjuvanted vaccine. Only 6% of subjects achieved a protective response when given two doses of the 15ug un-adjuvanted vaccine. The full data set from the trial will be submitted to a peer-reviewed journal for publication in the near future.
The vaccine was produced utilizing full-scale cell-culture manufacturing technology, an alternative technology that can significantly accelerate vaccine production versus traditional egg-based methods.[1] Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.[2]
"This rapid response underscores our leadership position in pandemic preparedness" said Andrin Oswald, Division Head, Novartis Vaccines. "Thanks to our investments into innovative production technologies and adjuvants, we are now able to offer a protective solution for a potentially deadly pandemic virus within a few months after the emergence of the H7N9 virus."
Reports of H7N9 infection first emerged in China in March 2013. Novartis, along with its partners at the Craig Venter Institute, first synthesized the viral strain several days after it was shared with global researchers by the Chinese Centers for Disease Control. Novartis then produced clinical trial lots, began clinical trials in August, and initiated large-scale production in its Holly Springs (NC), USA and Marburg, Germany facilities in October.
This project has been funded in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO1002012000141
About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time equivalent associates and operate in more than 140 countries around the world.
1. U.S. Department of Health and Human Services. "HHS Awards Contracts Totaling More Than $1 Billion to Develop Cell-Based Influenza Vaccine." 2006 Available at: http://archive.hhs.gov/news/press/2006pres/20060504.html.
2. Ambrozaitis, Arvydas et al. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. Vol 27. Issue 43. October 9, 2009: 6022-6029. Available at: http://www.sciencedirect.com/science/article/pii/S0264410X09011177. Accessed on October 3, 2012.