7 min readPuneAug 12, 2020 09:52 AM IST
First published on: Aug 12, 2020 at 09:52 AM IST
Russia has delivered on its promise to develop the world’s first vaccine for novel Coronavirus. On Tuesday, it announced that it had approved a vaccine being developed by Moscow’s Gamaleya Institute. The announcement has been met with excitement as well as skepticism due to the fact that the vaccine has been cleared without phase-3 human trials. Even the phase-1 and phase-2 trials have been rushed, all of it being completed within two months.
However, it still might be some distance away from becoming generally accessible, especially to people outside Russia. The vaccine is likely to get into production immediately. Apart from the facility at the Gamaleya Institute itself, it is supposed to be manufactured by Sistema, a big Russian business house. In a statement on Tuesday, Sistema said the first batches of the vaccine were ready, and would be shortly shipped to Russian provinces to be administered first to doctors and healthcare workers who are at high risk of infection.
However, the Sistema facility has the capacity to produce only 1.5 million doses of a vaccine in a year, a woefully inadequate quantity considering that the immediate global demand is of billions of doses. As a result, Russia’s capability to service the demand in other countries looks severely limited, as of now. Russia has, however, said it had entered into international agreements to produce 500 million doses of the vaccine annually. It has also said that it had received requests for 1 billion doses of the vaccine from foreign countries.
But even if the manufacturing issue is taken care of, there is regulatory hurdle to be crossed in the deployment of the Russian vaccine in countries like India. There are two ways in which this vaccine can be approved for use in India. The Indian regulatory system requires at least late phase human trials to be conducted on local population before any vaccine, or drug, developed in other countries, is approved for use in India. That is because a vaccine generally elicits different immune responses from different population groups. That would mean that the Russian developers, or their partners in India, would have to carry out phase-2 and phase-3 trials on the vaccine on Indian volunteers. This is the process that was recently followed in the case of the vaccine being developed by Oxford University and AstraZeneca. Pune-based Serum Institute of India, which has a manufacturing agreement with the developers to produce the vaccine, recently received the regulator’s nod to conduct phase-2 and phase-3 trials on the vaccine in India. Only if these tests are satisfactory that the Oxford University vaccine would be allowed to be used on Indian people.
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Even in the current fast-paced environment, phase-2 and phase-3 trials of the Russian vaccine in India would take at least two to three months. That is, after someone moves an application before the drug regulator asking for permission to conduct the trials. So far, no such application has been moved.
But considering the current urgent situation, the Russian vaccine can also get an emergency authorization from India’s drug regulator. That would allow the vaccine to be used without the late phase trials. The drug regulator can say that it is satisfied with the results of the human trials conducted in Russia, and considering the gravity of the prevailing situation, it can grant emergency approval to the vaccine, without the need for human trials in India. Recently, the drug Remdesivir was granted such emergency approval, to be administered to novel Coronavirus patients.
But this is a route that experts believe is unlikely to be taken in the case of Russian vaccine. That is because, unlike a drug that is given only to patients, and that too only at the consideration of the doctor, the vaccine is supposed to be administered to general public. More so in the case of the current pandemic. For most of the other diseases, only children are vaccinated these days, because the older populations have already been vaccinated earlier. But for novel Coronavirus, everyone needs to be vaccinated. The risk of using a vaccine on such large number of people without having conducted late phase trials are much higher. Also, Remdesivir was an already approved drug that was just being re-purposed to treat Coronavirus patients. Its safety was never in doubt. Only its effectiveness on treating Covid-19 disease was uncertain. In the case of the Russian vaccine, however, even the safety of the vaccine would be uncertain if the late phase trials are not conducted.
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Only half of respondents in UK survey hopeful of getting Coronavirus vaccine
Not everyone seems to be excited with the prospect of having a novel Coroanvirus vaccine, though. A new research survey in the United Kingdom shows that just over half the population was sure of getting the vaccine when it was available. In a survey of 2,237 UK residents carried out by researches from King’s College London, and polling agency Ipsos MORI, only 53 per cent of the respondents said they would be certain, or very likely, to get the vaccine. About 16 per cent of surveyed people said they were unlikely to, or definitely won’t, get the vaccine.
Similar polls carried out in the United States in June and July have showed between 50 per cent to 67 per cent people willing to take the vaccine shots when it becomes available.
An employee works with a coronavirus vaccine at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia. (Alexander Zemlianichenko Jr/ Russian Direct Investment Fund via AP)
Russian vaccine is not the first one… a Chinese vaccine is already in use
Incidentally, the Russian vaccine against novel Coroanvirus is the not the first one to be approved. A Chinese vaccine, developed by CanSino Biologicals, was approved in June itself. But it was meant only for limited use, to be administered on soldiers of the People’s Liberation Army. China’s Academy of Military Medical Sciences is a co-developer of the vaccine.
It is not known how many soldiers of the Chinese army have already been given this vaccine.
Like the Russian vaccine, this one too was approved without phase-3 human trials. A couple of days, the company announced that it would getting ready to conduct phase-3 trials in a hospital in Saudi Arabia.
Hunt for Coronavirus vaccine: The story so far
- Russia announces its novel Coronavirus vaccine is ready
- More than 160 vaccine candidates in pre-clinical or clinical trials
- 28 of them in clinical (human) trials. At least seven of them are by Chinese companies or research institutions
- Five of them in final stages, phase-3 of human trials (the Russian vaccine is shown in phase-1 of human trials)
- At least eight candidate vaccines being developed in India. Two of these have entered phase -II trials after completing phase-I.
(As on August 10)
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The new vaccine is on display at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia. (Alexander Zemlianichenko Jr/ Russian Direct Investment Fund via AP) 
An employee works with a coronavirus vaccine at the Nikolai Gamaleya National Center of Epidemiology and Microbiology in Moscow, Russia. (Alexander Zemlianichenko Jr/ Russian Direct Investment Fund via AP)
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