(Adds further details on vaccine, Novartis comment)
By Ben Hirschler
LONDON, April 27 (Reuters) - A new kind of seasonal flu vaccine made in cell culture, rather than chicken eggs, and which could be quickly mass-produced in the event of a pandemic was endorsed by Europe’s drugs watchdog on Friday.
The European Medicines Agency said it had given a positive opinion to Novartis AG’s NOVN.VX Optaflu, clearing the way for full European marketing approval within two or three months.
Optaflu marks the first major innovation in flu vaccine production in more than 50 years.
Experts have been encouraging drugmakers to develop more modern methods to make flu vaccines, in order to be able to scale up production rapidly. That is particularly important given the threat of a flu pandemic, which many fear could be triggered by bird flu.
The current vaccine production technology using chicken eggs is unwieldy and slow, as the virus must be taken from people, purified and grown in fertilised chicken eggs. The process takes months and can easily go wrong.
Cell-culture methods will accelerate this procedure and may also produce a vaccine that is better matched with circulating virus types, according to Novartis. “Optaflu contributes to meeting the growing demand for seasonal influenza vaccines, and this production technology offers the potential for quick scale-up of manufacturing in the event of an influenza pandemic,” Novartis vaccines head Joerg Reinhardt said in a statement.
Using mammalian cell culture, rather than chicken eggs, could also be critical if a pandemic arises from the H5N1 virus strain circulating in birds, since supplies of eggs may well be limited.
H5N1 has killed more than 180 people since 2003 but the virus does not currently spread easily between people -- a prerequisite for a pandemic.
Novartis expects to file Optaflu for U.S. regulatory approval next year.
Like conventional egg-based vaccines, Optaflu is given as an intramuscular injection.
((Reporting by Ben Hirschler, editing by Erica Billingham and Matthew Tostevin; email: email@example.com; Reuters Messaging: firstname.lastname@example.org; +44 20 7542 5082)) Keywords: NOVARTIS FLU/
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