As Russia became the first country to register a Covid-19 vaccine within two months of starting human trials, experts and scientists world over, including in India, have been left baffled and alarmed as no safety data, thus far, is available on this.
Russian President Vladimir Putin on Tuesday said that one of his daughters has already been immunised using the vaccine developed by Gamaleya Research Institute and the Russian defence ministry, the vaccine underwent necessary tests, Russia claimed.
“I know it has proven efficient and forms a stable immunity, and I would like to repeat that it has passed all the necessary tests,” Putin was quoted as saying.
The vaccine named Sputnik V, has been developed using inanimate particles created on the basis of adenovirus — a common cold virus — and is set to be available for public use in the coming weeks.
Vaccine experts in India meanwhile pointed out that almost no scientific detail on the vaccine is available, and it was beyond explanation how it could have been established that it was safe and effective within a few weeks of starting human testing.
“I have been looking to find out technical details related to the vaccine in scientific journals globally but could not get any,” said Dr Sudhanshu Vrati, senior virologist who heads the Regional Centre for Biotechnology in Faridabad.
He said that an utterly rushed launch of the vaccine, based on just phase 1 trials on undisclosed number of volunteers, seemed a direct result of “vaccine politics” that seems to have engulfed many countries.
Virologist Dr Shahid Jameel pointed out that there is more to proving safety and efficacy of a vaccine for humans beyond phase 1.
“I also read that Putin claimed it was tested on his daughter. I guess that says a lot. This race to be the first is rather silly,” he said.
Dr Vrati stressed that rigorous drug and vaccine testing are particularly important as many vaccines could end up deteriorating the disease in case of actual exposure to the virus.
“That happens in case of dengue. That’s why merely showing that a vaccine generates antibodies is not enough. It has to be assessed to what extent it works and for how long and it has to be tried in a considerably large number of volunteers before launching mass vaccination programmes,” he said. “But in this case, clearly that has not happened.”
Dr Anant Bhan, researcher in global health and bioethics too said that in the absence of any published data on the vaccine, and information seemingly suggesting that the clinical trials have not looked at long term immunogenicity or vaccine efficacy especially through well-conducted phase 3 studies, it seems premature to be launching a vaccine, and then planning mass vaccination as a follow-up.
‘This could mean there is not enough time and data to establish safety and efficacy of the vaccine before it is used, and that could entail risks,” he said.
A major controversy had broken out in India last month when the chief of Indian Council of Medical Research had last month urged researchers involved in the trial of a vaccine by Bharat Biotech to “fast-track” the processes in order to launch the vaccine by August 15. The uproar had forced the government health research body to later clarify on the matter.