Top Russian doctor quits over questionable ethics that rushed through coronavirus vaccine approval

pharmafile | August 14, 2020 | News story | Medical Communications  

Professor Alexander Chuchalin has quit the Russian Health Ministry’s ethics council due to the quick approval process for the country’s coronavirus vaccine.

Many countries have criticised Russia pursuit for a COVID-19 cure, which has skipped Phase 3 trials before giving the vaccine regulatory approval. It seems Chuchalin had tried and failed to block its registration on safety grounds. He accused the two leading medics involved in its development of flouting medical ethics in process. These were Professor Alexander Gintsburg, the Director of the Gamaleya Research Centre for Epidemiology and Microbiology and Professor Sergey Borisevich, who is a medical colonel and Russian army’s top virologist and they are the leading figures behind the vaccines.

According to the MailOnline, Chuchalin said to them: “Have you passed all the necessary paths approved by the Russian Federation legislation and the international scientific community? This job has not been done. Thus, one of the ethical principles of medicine has been grossly violated – to do no harm.”

He also said: “I am depressed by the position of some of our scientists who make irresponsible statements about ready-made vaccines.”

He also told the scientific journal Nauka i Zhizn that: “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 number one 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.”

Russia approved its coronavirus vaccine this week, named Sputnik V after the USSR’s satellite programs.  In July, Clinical trials were conducted on volunteers at the Sechenov First Moscow State Medical University and involved 38 people in two separate groups. Allegedly, the vaccine proved to be effective and safe and is being developed and produced by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology along with the Russian defence ministry.

But there is no public data available on this trial and the only information on the completion of clinical trials is from the Russian state. There are also rumours that the vaccine has already been giving to Russia’s elite and researchers may have dosed themselves as part of the clinical trials.

Conor Kavanagh

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