Novartis launches first seasonal flu vaccine to use cell culture technology in UK

The first influenza vaccine to utilise cell culture manufacturing technology rather than the traditional chicken egg technique for vaccine production has been launched in the UK by Novartis. The new influenza vaccine will be available for GPs to order from this week, for use in the 2008/9 flu season.

Optaflu from Novartis Vaccines is the first major innovation in influenza vaccine production in more than 50 years, offering faster, more flexible manufacturing. It was approved in all 27 EU member states as well as Iceland and Norway in June.

One of the key advantages to the new technology is the speed of manufacture, enabling vaccine production to be ramped up quickly in case of a pandemic influenza outbreak.

Evidence is also emerging that cell-line influenza vaccines may be able to more closely match "wild-type" circulating flu strains. This is because the new technology eliminates the use of eggs where the wild virus sometimes mutates during the growing process, or is deliberately slightly altered to make it grow better. Vaccines strains that closely mirror the wild virus work better than those with an inexact match.¹

The basis for the new technology is a cell line derived from the kidney of a healthy dog. It is called the MDCK cell line (Madin-Darby Canine Kidney), after its orginators SH Madin and NB Darby, who first used it in 1958.² Since then the cell line has been widely used in a variety of medical procedures, but this is the first time it has been used to make an influenza vaccine.

More than 3,400 people received Optaflu during the clinical development programme evaluating the vaccine's safety and immunogenicity. This data showed Optaflu fulfilled all of the EU's immunogenicity and safety criteria. The results further showed this cell culture-derived vaccine was comparable to conventional egg-based vaccines in stimulating an immune response and tolerability.

Professor John Oxford, Professor of Virology at Queen Mary's School of Medicine, St Bart's and the Royal London Hospital, London, said the new technology gave "production line insurance" if manufacturing had to be quickly switched from traditional influenza to pandemic influenza. "It is always good to have a new weapon against seasonal influenza, especially if it can produce a closer match between the strains in the vaccine and the real strains that circulate in the population.

"However one of the longer-term benefits of cell production will be its ability to respond more rapidly when influenza strains change or new ones - like H5N1 - emerge."

"Egg vaccine technology has worked very well for years, and undoubtedly will continue to be used on a large scale for many more years. However, this new cell technique does offer more flexibility in manufacture," said Dr Rino Rappuoli, global head vaccines research at Novartis Vaccines and Diagnostics. "The process can be completed in just four months, compared with egg vaccine manufacture that can take up to nine months to produce and even longer to organise the egg supply.

"It is also suitable for large scale manufacture; the process can be ramped up and run repeatedly. The scale is therefore sufficient to provide vaccine for inter-pandemic and pandemic periods."