Novavax, A United States company, has now reported in the New England Journal of Medicine that 80% of people may be protected by the generation of anti-H7N9 antibodies in response to 2x 5�g injections in the presence of 60 units of CSL's Iscomatrix adjuvant (see more on adjuvants in my August piece). 284 people were enrolled in a trial in Australia to determine these "very preliminary" results. Increased reactions were seen among the immunized at the injection site, but few were severe.
The move away from the egg-based vaccine manufacturing system is likely to allow vaccines to be produced in much shorter periods; 12-weeks after an outbreak starts, with 50,000,000 doses potentially available in 4-months.
You may ask, why then is it precisely 9-months after the 1st H7N9 case was retrospectively identified, and Novavax is still only at Phase I trials? I think, and I'm no expert in this area, that the process will increase in speed once the 'backbone' (the VLPs being used here which are based on a baculovirus, all produced in insect cells) in combination with this adjuvant etc, have been through the entire clinical trial process the first time. A successful backbone can be leveraged for other vaccines too.
You can see a little more of the process of making the VLPs, in this case for respiratory syncytial virus, here.
So, big changes lie not-too-far ahead for influenza vaccines....assuming the course through clicnial trials is smooth sailing of course!
For those hypersensitive to hyperlinks...
- http://newsmedicalnet.blogspot.com.au/2013/08/h7n9-vaccine-update.html
- http://clinicaltrials.gov/ct2/show/NCT01897701?term=novavax&rank=4
- http://www.fiercevaccines.com/story/novavax-presents-positive-phase-i-data-h7n9-vaccine/2013-11-14
- More on Iscomatrix. http://www.who.int/vaccine_research/about/2003_novel_adjuvants/en/03_drane.pdf
- CSL.
http://www.csl.com.au/home - Publication in Bioprocessing Journal (behind a paywall).
http://www.bioprocessingjournal.com/index.php/article-downloads/527-j122-rapid-manufacture-and-release-of-a-gmp-batch-of-avian-influenza-ah7n9-virus-like-particle-vaccine-made-using-recombinant-baculovirus-sf9-insect-cell-culture-technology
