The COVID-19 pandemic has moved into India in a big way as that country becomes the second most impacted worldwide next to the United States. India now has reported over 4.3 million cases and nearly 74,000 deaths. A few indigenous vaccines are underway and in clinical development while recently it was announced the Russia’s Sputnik V would be available in India in the form of a clinical trial. Recently, Kirill Dmitriev shared in Sputnik News that a Phase 3 trial in Russia will include 40,000 while Sputnik V trials will also commence in India, among other nations. Professor Gagandeep Kang, who works for the Gastrointestinal Sciences division of Christian Medical College, reemphasized her work on education and research. In a recent interview, she emphasized that the Sputnik V was not ready for prime time, at least in India.
Professor Kang was recently interviewed by News18 in India on a number of topics associated with the COVID-19 pandemic and India’s worsening situation. When asked about Sputnik V’s registration in Russia she had some fairly critical observations. For example, the recent Lancet data was for all practical purposes, “early phase, small amount of safety data and small amount of immunogenicity. That is like Phase one and maybe small phase two type study because you have both safety and immunogenicity.”
More Clinical Trials Testing Sputnik V Required
Professor Kang emphasizes that the Indian government should be overseeing more clinical research investigating Sputnik V for clinical efficacy. She emphasized just because the vaccine was approved (registered) in Russia “doesn’t mean it is ready for primetime use in a country like India, you need clinical efficacy data on the vaccine.” Professor Kang emphasized that “safety, immunogenicity and efficacy are three separate things.” The professor makes it clear, “I don’t think we should use any vaccine where we don’t have clinical efficacy.” Hence, a small amount of Phase 1 data revealing safety and immunogenicity isn’t sufficient. But that’s probably why Mr. Kirill announced that a Phase 3 trial in Russia is enrolling up to 40,000 participants. As it turns out, the Russia Sputnik V registration was just as much marketing as it was material proof of a clinically efficacious product.
Call to Action: Follow the link to News18 to review the entire interview with Professor Kang.