Russia has kept its promise, and approved a novel coronavirus vaccine for public use without the final phase of human trials. It is the first coronavirus vaccine to be approved, though a Chinese vaccine has been cleared for ‘limited use’ much earlier, to be administered only on soldiers of the People’s Liberation Army.
The Russian vaccine, developed by Moscow-based Gamaleya Institute, has cleared regulatory approvals in record time, less than two months after it got into human trials, raising concerns over its safety and effectiveness. The other vaccine candidates in human trials are not expected to be ready before early next year.
Production & availability
Apart from Gamaleya Institute’s own facility, the vaccine is supposed to be produced at a plant owned by Sistema, one of Russia’s biggest business groups. Sistema said its facility had the capacity to produce 1.5 million doses per year, and this capacity was being ramped up.
For regions outside Russia, it might still be some time before the Russian vaccine is available. A Reuters report on Tuesday quoted the head of Russia’s sovereign wealth fund as saying that requests for 1 billion doses of the vaccine had been received from other countries, and that international agreements had been secured to produce 500 million doses annually. It did not name the countries which have showed interest in the Russian vaccine.
Will it come to India?
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, usually both phase-2 and phase-3, on an Indian population. This is the usual requirement for all vaccines developed outside of India.
Late-phase human trials are important because the vaccine’s efficacy can differ on different population groups. This is the route being taken by vaccine candidate being developed by Oxford University, for example. The CDSCO recently gave its go-ahead to late-phase trials on Indian volunteers. The Oxford vaccine trials are expected to begin this week.
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Considering the extraordinary situation right now, 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 drug remdesivir was recently granted similar emergency approval to be used as a therapeutic on novel coronavirus patients. But this option is unlikely to be exercised with the Russian vaccine. Unlike a drug that is administered only to patients, vaccines are inoculated to large number of people. In the case of this disease, specifically, everyone needs to be vaccinated. The risks involved are much higher. Also, remdesivir was an already approved drug for other ailments and was just being repurposed for treatment for novel coronavirus, while the vaccine is new.
No manufacturing agreement
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, wherever they are developed, 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. Other Indian companies have also done similar agreements. There is no agreement for production of Russian vaccine in India right now.
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