Novartis says its new cell culture plant in Holly Springs, North Carolina could begin making its flu vaccine boosting MF59 adjuvant as early as next month if approved by US regulators.
Speaking at the inauguration of the facility, the Swiss firm said that although MF59 is not cleared in the US, data from ongoing trials show that vaccines containing the adjuvant can induce protective immunity against H1N1 after a single dose.
The ability to induce protection after just one vaccination is significant because it will both extend government stockpiles and mean that more people can be treated in a shorter time, which is a key part of the strategy to controlling the spread of influenza.
Earlier this month the US government said that its H1N1 vaccine stockpile is only sufficient to immunize 7 per cent of the 160m citizens expected to seek treatment, engendering significant criticism.
And, while subsequent efforts have improved the situation, the Centers for Disease Control and Prevention (CDC) recently said it has 54.1m vaccines, there is still a need to make existing supplies go further.
MF59, which has been approved in the European Union in Novartis’ seasonal influenza vaccine Fluad since 1997, has previously been shown to reduce the amount of viral antigen needed to induce protective immunity from 15mcg to 7.5mcg,
Cell culture response to H1N1
The Holly Springs site, construction of which began in January , is the US’ first cell culture influenza vaccine plant and is the result of collaboration between Novartis and the Department of Health and Human Services (HHS).
The facility, which is scheduled to be fully operational in 2013, is intended to replace traditional egg-based vaccine production with more rapid cell culture manufacturing methods as part of the US government's pandemic response programme.
This point was emphasised by Novartis CEO Daniel Vasella at yesterday’s ceremony, who said there is “a great need to invest into new technologies for flu vaccines that will allow for quicker and more reliable production."
Vasella went on to say that: “We are pleased to be working closely with the US government to build a world-class, state of the art manufacturing facility in the US that will change the way we manufacture influenza vaccines in the future.