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Novartis announced today new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company’s influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (>=65 years of age).
The data also showed a single 3.75µg dose of MF59-adjuvanted A(H1N1) 2009 vaccine met serologic protection criteria against influenza A(H1N1) in children ages 3 to 8, adults ages 18 to 64, and the elderly. All A(H1N1) 2009 influenza study vaccines were manufactured using the Novartis established seasonal Fluvirin® manufacturing platform. Novartis has discussed these new data with the US Food and Drug Administration (FDA) and is performing additional statistical analysis suggested by the agency. It is still under evaluation whether the antigen content per dose can be reduced in the US.
Current US guidelines for A(H1N1) 2009 vaccine use state that adolescents, adults and the elderly are required to receive one 15µg dose to achieve adequate protective antibody levels against the A(H1N1) virus, and children 9 years of age and under are required to receive two 15µg doses four weeks apart.
“These promising data suggest that many more people could potentially be vaccinated with our current vaccines supply, protecting more people earlier against the current pandemic,” said Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. “The data also confirms the antigen sparing potential of our proprietary adjuvant, MF59. The vaccines output of our Liverpool, UK, based flu manufacturing facility, fully dedicated to the US since the emergence of the pandemic, could be quadrupled if vaccines are adjuvanted.”
These interim data were generated from pivotal clinical studies designed to evaluate the immunogenicity, safety and reactogenicity of both MF59-adjuvanted and unadjuvanted, inactivated novel swine origin A(H1N1) 2009 monovalent subunit influenza virus vaccine in 4,080 US subjects. In the pediatric trial, the findings are based on 80% of first dose data from 1,360 subjects ages 3 to 8 at day 22. In the adult trial, the findings are based on 95% of first dose data at day 1 and day 8 and approximately 40% of first dose data at day 22 from 1,360 adult subjects and 1,360 elderly subjects. Second dose data and data in ages 6-36 months of age are expected in December 2009.