Professor Alexander Chuchalin quit the Russian health ministry’s ethics council after making a fierce attack on the new Sputnik V drug ahead of the body approving its registration.
Amid deep skepticism among Western experts over the drug, it appears that Chuchalin tried but failed to block its registration on ‘safety’ grounds before quitting the ethics council.
He specifically accused the two leading medics involved in its development of flouting medical ethics — Prof Alexander Gintsburg, director of the Gamaleya Research Centre for Epidemiology and Microbiology, and Prof Sergey Borisevich, a medical colonel and Russian army’s top virologist– in rushing the vaccine into production.
The two men were the leading academics behind the new ‘world-beating’ vaccine.
Chuchalin allegedly asked them: ‘Have you passed all the necessary paths approved by Russian Federation legislation and the international scientific community? Not!
‘This job has not been done. Thus, one of the ethical principles of medicine has been grossly violated – to do no harm.’
“I am depressed by the position of some of our scientists who make irresponsible statements about ready-made vaccines.”Professor Alexander Chuchalin
Although specific reasons for his resignation were not disclosed, Chuchalin warned: ‘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, he said in an interview with journal Nauka i Zhizn (Science and Life) shortly before he quit.
“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.”
Chucalin, who created the Russian Research Institute of Pulmonology, and is head of the Department of Hospital Therapy, at the Pirogov Russian National Research Medical University, added: ‘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.”
Chuchalin said it is vital to know “the effect of the vaccine in the longer term,” adding that “the fact is that there are a number of biological substances that do not manifest themselves immediately, but only after a year or two.”
With Russia also preparing other vaccines to tackle Covid-19, he warned: “Those vaccines that are now being developed by many of our research centres, the criteria for their safety can only be of a short-term nature.”
“But the safety criteria for a vaccine must also be long-term and this becomes clear only with long-term observation – at least two years.”
And one of Russia’s leading virologists has even warned that the vaccine could increase the spread of Covid-19.
In a separate attack on the vaccine, Prof Alexander Chepurnov, former head of the laboratory for specially hazardous diseases at Vector Institute in Siberia which is also involved in developing vaccines for coronavirus, said the ‘danger exists’ of ‘increasing the disease with the wrong design of the vaccine’.
“Time is needed….antibodies are different. In some situations – and for coronavirus, this is already known – the infection intensifies with some antibodies. It should be known which antibodies the vaccine produces.”Prof Alexander Chepurnov
But the vaccine creators had not published scientific articles on the vaccine, he said. “They need to explain the level of neutralisation, and details of doses and ‘whether it develops or not the ability to increase infection by antibodies,” Chepurnov added. “While this is not done ‘it is impossible to talk about the release of a vaccine.”
Another leading scientist Vladimir Chekhonin, Vice President of the Russian Academy of Sciences, claimed Russia was violating the Nuremberg Code on human experimentation and the country’s own laws in human clinical research involved in Covid-19 vaccine testing. He expressed concern about the use of serving military personnel as recipients of the vaccine.
“We cannot conduct experiments on humans. This is a gross violation of the international Nuremberg Code. We are just making fools of ourselves with this early vaccine that can bring us a lot of trouble,” Chekhonin said.
He also stressed that “Scientists ‘do not have the ethical right to speak to society and defiantly drip the vaccine into their nose or inject it into other places.”
According to Daily Mail’s article, documentation linked to the vaccine said it was registered after tests on only 38 healthy adult volunteers.
However it is now said it was tested on double this number – 76 – at two institutions — the Moscow-based Sechenov University and the Defence Ministry’s Burdenko Main Military Clinical Hospital.
It is unclear why the documentation linked to Sputnik V used the figure 38. Of the 76, around half are believed to have been serving military personnel who took part ‘voluntarily’.
Putin said one of his daughters had been given the vaccine and had suffered no side effects worse than a high temperature.
‘She’s feeling well and has a high number of antibodies,’ he boasted.
She had the vaccination at a very early stage of its development, it was claimed, however, there was no official confirmation that she was the vaccine’s recipient.