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Indian Regulators Cut Corners to Expedite Indian Covid Vaccine: So, What?
(Thursday, November 17, 2022) At the height of the Covid pandemic, Indian regulators cut corners to expedite an indigenous vaccine, Covaxin. While the process followed may be questioned, in all fairness, this decision saved the lives of tens of millions of Indians. It does not reflect on the entire Indian regulatory process, and it does not mean that every product manufactured in India follows this process, as implied by the exposé published this week in the US news media. It is important to put this information in context. In mid-2020, at the height of the pandemic, when patients were dying by the tens of thousands each day, several vaccines were being developed worldwide with the US-based companies leading the race. The US and the Western European countries had pre-ordered practically the entire projected supply of the vaccines being developed by companies based in these regions, guaranteeing that unless other countries find an alternate source of the Covid vaccines, they would face hundreds of millions of deaths before the US-developed vaccines become available to them. On top, the leading vaccines being developed in the West, were based on a technology never used before, the mRNA vaccines. India, with a population four times that of the US and population concentration about 6-8 times that of the US, was facing a catastrophe, unless its government and regulators took extreme steps. The Indian government co-developed Covaxin, with an Indian manufacturer and rushed it through its regulatory and clinical development process. Cavaxin is an attenuated viral vaccine in adjuvants, the same technology used for decades for the flu vaccines. Such vaccines are generally accepted to be safe and were being tried in other countries as well. While the news story this week describes all the shortcuts taken by the Indians, it does not acknowledge that the vaccine met its goal. Covaxin has been administered to more than 352 million people in India alone, and several millions in other countries, mostly poorer and resource-limited, with an adverse reaction rate of about 0.01% and a fatality rate of around 0.0001%, very similar to that observed with the vaccines approved by the US FDA and EMA. There is no doubt that the process followed was not per the standards established by the US FDA, but the documents cited in the story show that the Indian laws were followed. Neither the Indian regulators nor the medical boards involved in the approval of Covaxin, have raised any questions about the vaccine. It also cannot be denied that it is very likely that without taking those measures, the vaccine would have been delayed by months or longer, leading to potentially millions of preventable Covid-related deaths. India has achieved a vaccination rate of 94% and controlled the pandemic at par with the Western countries, something that would have been unimaginable without the indigenous vaccines. From a regulatory point of view, the Indian regulators took a “risk-based approach” similar to that advocated by the US FDA, where when facing a life-threatening serious disease with no treatment options, it relied on preliminary clinical evidence, historical safety records of the underlying technology, and independent regulatory reviews for safety, to expedite Covaxin. It is fair to critique the approach, but it is not fair to present a one-sided story without contextualizing the events. And it is also not fair to paint the entire Indian regulatory process to be compromised. During critical health emergencies, countries need to take decisions to protect their citizens based on what they believe is in their citizens’ best interest. Indian regulators did just that. Under the circumstances, the end justified the means. Perhaps, other regulators can take a lesson from this when facing similar conditions. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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