Optaflu is the first vaccine manufactured using Novartis' proprietary cell culture technology (as opposed to traditional egg-based techniques) to gain EU approval, getting the green light in all 27 member states, Iceland and Norway.
The vaccine has been approved for use against seasonal influenza, and is expected to be available in Germany and Austria for the 2007/8 flu season, and remaining EU countries in time for the 2008/9 season. Submission for US regulatory approval is anticipated during 2008.
Vaccine manufacturers worldwide are investigating alternatives to the somewhat cumbersome practice of vaccine manufacture based on chicken eggs, and Novartis is no exception, having developed a proprietary cell line that promises distinct advantages over the traditional egg-based approach.
Key benefits include advantages in terms of speed and flexibility of production - current methods based on chicken eggs take months to produce each batch of vaccine, not to mention the drawn out process of ordering the specially certified eggs which can result in lead times of up to a year.
Any shortage in the egg supply will also clearly impact on vaccine supply, so the risk of any kind of pathogen or pandemic affecting chicken and egg stocks poses serious problems for maintaining vaccine stocks. This is particularly significant as cases of avian influenza (H5N1), highly contagious in chickens, continue to crop up, with a pandemic strain having the potential to seriously impact chicken and egg supplies and vaccine production as a result.
As well as cell-based vaccine manufacture eliminating these problems, the increased speed of manufacture is truly noteworthy, reducing time scales from months to weeks, which could have a major impact in the event of a flu pandemic and preventing supply shortages.
Regulators worldwide have whole-heartedly backed the development of alternative flu vaccine production techniques, particularly after being stung during the 2004/5 flu season when the US flu vaccine supply was seriously affected by manufacturing problems at a plant operated by Chiron (now part of Novartis), threatening half the total US flu vaccine supply.
Virus cultivation using Novartis proprietary cell line also offers the possibility of more robust virus proliferation, according to the company, and also a vaccine seed strain development that more closely matches the original 'wild' virus.
This improved match is due to the fact that cell culture technology eliminates the need for the virus to pass through eggs where it may be forced to adapt in order to replicate. As a result, Novartis says, the antigen produced in the cell culture may express the surface of the wild type virus more authentically, potentially resulting in a more effective immunogenic response.
Optaflu has already been evaluated in trials involving over 3,400 people, which showed it to be comparable to conventional egg-based vaccines in stimulating an immune response and tolerability.
Although Optaflu is currently only approved as a seasonal flu vaccine, only a month ago Novartis also gained EU approval for its pandemic flu vaccine, Focetria. Although manufactured using standard egg-based production methods, Focetria incorporates Novartis' proprietary adjuvant MF59, which boosts the immune system and can significantly reduce the quantity of antigen required in each vaccine dose.
In addition to these recently approved flu vaccines, Novartis is also in the process of developing an H5N1 vaccine based on its cell culture technology.
