Russia has been ahead in the race of producing COVID-19 Vaccine for the world without the final phase of human trials . Amidst questions being raised about its credibility, safety and trials Russia seems all set for its high amount production and distribution.
The Russian vaccine that is being developed by Moscow-based Gamaleya Institute in collaboration with the country’s defence ministry, has cleared regulatory approvals in less than two months after it got into human trials, raising concerns over effectiveness. The other vaccine candidates in human trials are not expected to be ready before early next year. The World Health Organisation cautioned Russia against rushing through with its vaccine. Russia’s vaccine is based on the DNA of a SARS-CoV-2 type adenovirus, a common cold virus. The vaccine uses the weakened virus to deliver small parts of a pathogen and stimulate an immune response.
Apart from Gamaleya Institute’s own facility, the vaccine is supposed to be produced at a plant owned by Sistema. Sistema said its facility had the capacity to produce 1.5 million doses per year, and this capacity was being ramped up. Russia has, 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.
There are two ways in which the Russian vaccine can be made available in India. The Central Drugs Standard Control Organisation (CDSCO) can ask Russia to conduct late-phase human trials, on an Indian population. Late-phase human trials are important because the vaccine’s efficacy can differ on different population groups. The CDSCO recently gave its go-ahead to late-phase trials on Indian volunteers. The Oxford vaccine trials are expected to begin this week. CDSCO is also empowered to give emergency authorisation without late-phase trials. It can say it is satisfied with the safety and efficacy data produced during the human trials in Russia, and considering the extraordinary situation, can grant approval for emergency use.
The second issue is that of manufacture of the vaccine in India. More than 50% of vaccines for all kinds of diseases are currently manufactured in India. It is expected that a bulk of vaccines for novel coronavirus, would also be produced in India. Pune-based Serum Institute of India, the world’s largest manufacturer of vaccines by volume, has already entered into tie-ups with developers to mass-produce their vaccines but there is no agreement for production of Russian vaccine in India right now.
It might be a long way for the Russian Vaccine to reach India but its better to be on the safer side of the spectrum. India is about to undergo oxford vaccine human trials and if that is proven effected India will get its fair share of vaccine. India is yet to plan over the distribution of the vaccine if it all it is made.
