Lower does of H1N1 vaccine may be enough

H1N1 Vaccine

With flu season hotting up, debate over the use of Influenza A (H1N1) vaccines continues to divide opinion. Now, Swiss-based pharmaceutical giant Novartis has announced that half of the currently-approved US dose actually fulfils immune response criteria for adults and the elderly.

Novatis' announcement is based on new interim data from ongoing clinical trials, and shows how a single 3.75µg dose of MF59-adjuvanted A(H1N1) 2009 vaccine met serologic protection criteria against influenza A(H1N1) in children ages three to eight, adults ages 18 to 64, and the elderly.

As such, the pharmaceutical firm is now in discussions with the US Food and Drug Administration (FDA) and is set to perfrom additional analysis suggested by the agency.

Seasonal platform

Some analysts argue that Novartis already had the upper hand with the H1N1 vaccine, given that all H1N1 influenza study vaccines were manufactured using the Novartis established seasonal Fluvirin manufacturing platform. Novartis is now facing evaluation as to whether the antigen content per dose can be reduced in the US.

The data is particularly promising, given that current US guidelines for H1N1 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. Children under 9 are required to receive two 15µg doses four weeks apart.

If only half the dose is required, the new data from Novartis suggests that many more people could potentially be vaccinated with current vaccines supply, protecting more people earlier against the current pandemic.

According to 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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