Lower dose of Novartis swine flu vaccine could offer protection

Published: 18-Nov-2009
Regulatory

Swiss drugmaker Novartis has found that a single 7.5μg dose of its unadjuvanted swine flu vaccine, half of the currently approved dose, gives immunity to the virus in adults and the elderly.


Swiss drugmaker Novartis has found that a single 7.5μg dose of its unadjuvanted swine flu vaccine, half of the currently approved dose, gives immunity to the virus in adults and the elderly.

Clinical trials of around 4,000 individuals found that 50% of the current dose of Novartis" US-approved vaccine Flurivin gives immunity to adults.

The trial data also showed that a single 3.75μg dose of MF59-adjuvanted A(H1N1) 2009 vaccine met serologic protection criteria against influenza A(H1N1) in children aged 3 to 8, adults aged 18 to 64, and the elderly.

Novartis is discussing the findings with the US Food and Drug Administration (FDA), which is assessing whether the amount of vaccine 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."

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