A top member of Russia’s Health Ministry ethics council, Professor Alexander Chuchalin, has resigned over the quick review process for the world’s first approved COVID-19 vaccine, dubbed Sputnik V after the USSR’s satellite program.
Citing medicine’s guiding principle to “do no harm,” he tried to block the nod on safety grounds, accusing two leading doctors, the Gamaleya Research Centre for Epidemiology and Microbiology’s Professor Alexander Gintsburg and the Russian Army’s top virologist Professor Sergey Borisevich, of flouting medical ethics in the process.
The data supporting the approval was generated from only 38 volunteers from the military.
In an interview with the scientific journal Nauka/Zhizn, he said, “In the case of a drug or vaccine, we, as ethical reviewers, would like to understand, first of all, how safe it is for humans. Safety always comes first. How to evaluate it? The vaccines that are being created today have never been used in humans, and we cannot predict how a person will tolerate it. It is impossible to determine this without weighing all the scientific facts. Therefore, our #1 task is to extract scientific data based on evidence-based medicine in order to understand that the action performed by scientists will not harm a person. It is vital to know the effect of the vaccine in the longer term. The fact is that there are a number of biological substances that do not manifest themselves immediately, but only after a year or two.”
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