How safe will be Russia’s COVID-19 vaccine? Dr. Fauci expresses concern

Reports are rife that Russia is going to register the world’s first COVID-19 vaccine on August 12. According to media reports, the vaccine will be tested on around 1600 people for safety and efficacy post the registration. Developed jointly by Gamaleya Research Institute and the Russian Defence Ministry, it is currently at Phase III clinical trial. Dr. Anthony Fauci, the top infectious disease expert from the US has, however, expressed concerns over this fast-track approach. He has been quoted saying, “I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing I think is problematic at best.” Also Read – Can your face mask really prevent spread of COVID-19 droplets? Use this test to find out

The World Health Organization is also dubious about the safety and efficacy of Russia’s COVID-19 vaccine. This world body has urged Russia to follow the standard guidelines for developing safe and effective vaccines. Reportedly, the industrial production of the vaccine is supposed to start in September followed by mass vaccination in October. Also Read – COVID-19 Live Updates: Cases in India surge to 21,53,010 as death toll reaches 43,379

The trial story of this vaccine

As already mentioned, the Russian COVID-19 vaccine is currently at phase III clinical trial. The first human trials (Phase I) began barely two months ago with 76 volunteers. Half of them got the liquid form of the vaccine through shots while the rest got it as a soluble powder. A few of the volunteers for trial were military servicemen. Though they didn’t complain of any side effect, some others reported a few. Media reports also suggest that professor Alexander Gintsburg, head of the Gamaleya institute, and his researchers tested the vaccine on themselves, even before the human trial started. According to the information shared by the Russian Health Ministry, this vaccine is also going to be administered to high risk groups, such as healthcare workers. However, there is no confirmation that this would be part of its Phase III trial. Also Read – COVID-19 may have longer incubation period than previously thought

This rather headlong rush for a COVID-19 vaccine was triggered in Russia by President Vladimir Putin’s order to cut back on the time of clinical trials. Soon after this order, the Gamaleya vaccine received authorisation for clinical trials from the Health Ministry.

Major Concerns Over Safety and Research Protocol

Notably, Russia hasn’t yet published any scientific finding from the result of its phase I clinical trials and this Gamaleya product is still included in WHO’s list of vaccine candidates in Phase I clinical trials. Given this backdrop, it is but natural for experts and scientists to be worried about the safety and efficacy of this vaccine. The Russian Government’s assurance that it has yielded the desired results and doesn’t come with any side effect doesn’t make up for the lack of scientific data for sure.

Russia’s Association of Clinical Trials Organizations is also unhappy with Putin’s rushed approach which, according to the institute, set an “unattainable bar” for the scientists. They also questioned Gamaleya’s decision to test the vaccine on its researchers before the human trials started. According to agency reports, they described the move as a “crude violation of the very foundations of clinical research, Russian law and universally accepted international regulations” in an open letter to the government.

Not only this research body, many other Russian experts are also not welcoming this fast track approach towards something as crucial as COVID-19 vaccine. In fact, some are frowning at the hasty decision of giving an insufficiently tested vaccine to healthcare workers while others are doubting whether its Phase III clinical trial, which is supposed to involve thousands of participants, is sticking to the set guidelines. This final stage is of utmost importance because it is the litmus test for a vaccine’s safety and efficacy. A poorly tested vaccine not only comes with dangerous health consequences but also generates a false sense of safety and reliance among the general public.

How does this Russian vaccine work?

Created with inanimate particles that cannot multiply, this Russian vaccine is using a common cold virus known as adenovirus to prep the body for a COVID-19 infection and recognise it when it invades the body. This virus has been modified to ensure that it carries the ‘spike’ protein gene that coats the novel coronavirus.

Published : August 10, 2020 12:04 pm


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