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Novartis H1N1 vaccine effective at low dose

Data from ongoing clinical trials shows that a half-sized dose of Novartis' H1N1 vaccine provided the required protection in adults and the elderly

Swiss-based pharmaceutical company Novartis has announced that data from ongoing clinical trials involving around 4,000 adults shows that a half-sized dose of its unadjuvanted H1N1 vaccine provided the required immune response criteria in adults and the elderly.

US guidelines for the unadjuvanted H1N1 vaccine state that it took one dose of 15μg to achieve adequate protective antibody levels in adolescents, adults and the elderly. The guidelines also state that children must receive two 15μg doses administered four weeks apart. Currently, only the unadjuvanted form of the vaccine is approved in the US.

The interim data also showed that a single 3.75μg dose of the company's MF59-adjuvanted vaccine met the required protection criteria in all age groups – children aged 3 to 8, adults aged 18 to 64, and the elderly.

Over 45 million doses of the MF59 adjuvant have been administered in Europe since 1997 and Novartis is under contract from US authorities to produce 90 million doses of the MF59 vaccine by the end of November

"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.

This latest data shows that the number of people able to receive the MF59 vaccine could potentially be quadrupled.

18th November 2009

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