Global Regulatory Dilemma Due to the Less Effective Chinese Vaccine
(Thursday, January 14, 2021]​
This week it was announced that the Chinese vaccine is only about 50% effective. That’s about half of the effectiveness of the Pfizer and Moderna vaccines but still above FDA’s threshold for authorization. This creates a unique circumstance for the regulators worldwide. Answers to three critical questions would influence the regulatory outcome of the vaccines by WHO and FDA. First, is the data trustworthy? Multiple studies with the same vaccine have reported effectiveness data from more than 90% to about 50%. There is no obvious explanation for the diversity in the reports. The big difference between the clinical trials with the Chinese vaccines versus those for the Pfizer and Moderna vaccines is that while Pfizer/Moderna executed one comprehensive clinical trial program for their vaccines, the Chinese vaccine seems to be involved in multiple independently run clinical trials with seemingly unrelated players and diverse agenda. The Chinese manufacturer seems to be constantly trying to control the interpretation of the data from its various partners and the results is a mishmash of irreconcilable reports. The explanations of these discrepancies by the Chinese appear highly anecdotal making the entire data seem unreliable. It does not help that Chinese developers have a checkered history with the FDA and EMA. Key lesson to everyone: never let other people run your trial. You may think you are saving money for the trial, but you may be getting unusable data in return that may hurt your long-term profits and credibility. Second, knowing that vaccines exist with about double the effectiveness, how should the regulators justify approval of the Chinese vaccine for their populations? The key criteria for approval of diverse products for the same indication is the equivalence of the benefit from all products. This cannot be said for the Chinese vaccine. It would be akin to FDA approving multiple drugs for the exact same indication knowing that some products are clearly inferior to others. Safe to say, it is highly unlikely that the Chinese vaccine will be approved in developed countries like the US and EU. Third, isn’t some vaccine better than none? This is particularly important question for poorer countries that cannot afford or access the more expensive Pfizer and Moderna vaccine. Chinese vaccine is a lot cheaper and available. It has already been administered to millions of individuals worldwide with few reported adverse effects. So, even if is only provides partial benefit, it may be the only option available to several countries. Having vaccines with such diverse effectiveness could create a vaccination nightmare with the people getting more effective vaccines being more protected than others in the same population based on which vaccine they got. A 50% effectiveness is like flipping a coin with equal probability of protected and unprotected vaccinated individuals. How does one rate the protection of their overall population in that case? It literally creates discrimination based on vaccination. WHO and similar players looking to vaccinate the less fortunately populations may have to decide purely on the basis of financial and logistical reasons. And that would be a travesty in its own with the agencies knowingly giving less effective, and probably poor quality, vaccine to the populations that trust them, not to say that the Chinese would have gotten away with another poor quality but cheap product. The old saying that poorer countries get inferior product will come to haunt us again in 2021. In an ideal world, the Chinese vaccine should never be allowed for anyone till there is irrefutable and verifiable data for how effective it is. But will the world be that brave?

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: mkumar@fdamap.com
​ Linkedin: Mukesh Kumar, PhD, RAC
 Instagram: mukeshkumarrac 
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