Summary
- The quoted dates for Sinovac's vaccine development sound too god to be true
- The clinical trial was commenced just 5 weeks after vaccine production started - how was quality control fitted into this
- The Chinese govt who desperately need >1 billion doses of swine flu vaccine to prevent a national disaster are encouraging Sinovac to export most of its initial production which seems very odd
- Was there really sufficient time for proper regulatory approval of this new vaccine?
Analysis
Sinovac initiated the production of H1N1 vaccine on June 15, 2009 and initiated the clinical trial on July 22. On August 17, Sinovac announced its top-line positive results of H1N1 vaccine clinical trials, in which they claimed vaccine showed good safety and immunogenicity profiles after one shot. The Chinese regulators approved the vaccine in one day. Sinovac has contracted to sell much of its initial production to Korea and Malaysia amongst other countries. Belatedly only now has the Chinese govt contracted Sinovac to supply a tiny 3 million doses for domestic use.
The big question is whether the price of Sinovac achieving the unbelievably fast process from initial swine flu production to clinical trials to registration, was reduced quality given that it is hard to see how normal QA/QC procedures could have fitted into these time frames. This after all was a new vaccine for which no production or release assays existed 8 weeks ago. It would be interesting to know how all appropriate controls and assays could have been put in place within the quoted timeframe. Vaxine Pty Ltd has also had experience in developing and trialling a new swine flu vaccine developed by Protein Sciences Corporation and to maintain strigent quality standards would be hard pressed to achieve the Sinovac quoted time frames.
It will be interesting to hear what external non-Chinese regulators of purchasing countries such as Korea find when they do due diligence on how these extraordinary compressed time frames were achieved.
If the Sinovac swine flu data holds up to independent regulatory scrutiny, then Western vaccine manufacturers clearly have a lot to learn from the Chinese.
If not, then along with lead in paint on Chinese toys and melamine in Chinese milk it will just yet again emphasize the importance of never trusting what Chinese manufacturers claim about quality without first obtaining independent testing.
This author consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
