Wednesday, August 4, 2021
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Russia claims to have developed first covid vaccine,But Stage 3 of human trial still not over.

The vaccine developed by Russia is likely to get into production immediately. Apart from the facility at the Gamaleya Institute itself, the vaccine 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.

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.

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