The Sputnik V is the first COVID-19 vaccine from Russia. N. F. Gamaleya Federal Research Center for Epidemiology & Microbiology in Moscow is named after an incredible Russian scientist who dedicated his life to fighting disease through pioneering microbiology and vaccine research. It is apt that the first COVID-19 vaccine is coming from an institution named after him.
Already having more than 917,000 confirmed infections, Russia’s coronavirus caseload is currently fourth in the world after the United States, Brazil and India. The country has reported 15,400 deaths, with 92,000 people in hospital with the virus and 2,900 in intensive care, according to the health ministry.
Here are some important facts about Sputnik V you must be aware of:
1. The Sputnik V vaccine has been tested in fewer than 100 people who invited by the Russian Ministry of Health to become the world’s first approved COVID-19 vaccine.
2. Russian authorities seem to be depending on the generation of ‘neutralising’ antibodies in Phase 2 clinical trials for deciding that the vaccine candidate works. A neutralising antibody defends a cell from an infectious particle by neutralising any effect it has biologically.
3. Experts believe Phase 3 trials are where many promising vaccine candidates fail. A 2016 study, published in the journal JAMA Internal Medicine, analysed 640 Phase 3 drug trials in the US and discovered that 344, or over 50 per cent had failed.
4. According to Natalie Dean, an assistant professor of biostatistics at the University of Florida, “The last thing phase-3 trials do is examine safety. Earlier trials do this too, but larger trials allow for rarer side effects to be detected. One such effect is a paradoxical phenomenon known as immune enhancement, in which a vaccinated person’s immune system overreacts to infection. Researchers can test for this by comparing the rates of disease severe enough to require hospitalisation across two groups.”
5. There are eight other vaccine candidates. These have entered the final phase (Phase Three) of human testing in large populations, including the ones produced by Moderna in the US, Oxford University and AstraZeneca in Britain, and multiple Chinese companies, Russia is the only one who has already given approval to its first coronavirus vaccine without going through the Phase Three testing.
6. According to Svetlana Zavidova, Moscow-based Association of Clinical Trials Organizations (ACTO) Executive Director said in a letter to Russian Health Minister Mikhail Murashko, “Why are all corporations following the rules, but Russian ones aren’t? The rules for conducting clinical trials are written in blood. They can’t be violated,” “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”
What is Vladmir Putin saying?
The Russian strongman said that Russia had become the first country to approve a vaccine offering “sustainable immunity” against the coronavirus. He added that one of his daughters had been inoculated with the vaccine, developed by the Gamaleya research institute in coordination with the Russian defence ministry. “In this sense she took part in the experiment,” Putin said, adding that she had a slight temperature after a second injection and “that’s all”. “What counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” Putin said.
What is WHO saying?
According to WHO spokesman Tarik Jasarevic who briefed the U.N. in Geneva, said that they’ve had talks with the Russians hoping to finalize a prequalification. He said, “We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine, but again prequalification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data.”
Did you know?
The vaccine developed by Russia is a so-called viral vector vaccine, meaning it employs another virus to carry the DNA encoding of the needed immune response into cells. Gamaleya’s vaccine is based on the adenovirus, a similar technology to the coronavirus vaccine prototype developed by China’s CanSino. The state-run Gamaleya institute came under fire after researchers and its director injected themselves with the prototype several months ago, with specialists criticising the move as an unorthodox and rushed way of starting human trials.
Russia, as far as Putin is concerned, is the first country to produce a viable vaccine which has been named ‘Sputnik V’ for foreign markets, a reference to the world’s first satellite. Already, requests from more than 20 countries for 1 billion doses of its newly-registered COVID-19 vaccine has been ordered.