Why is the Russian coronavirus vaccine far from being available?

Russia has kept its promise, and approved a novel coronavirus vaccine for public use without the final phase of human trials.
Here’s everything you need to know about this vaccine.

~ 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.)

~ Russia has named its coronavirus vaccine Sputnik V — a reminder of the satellite race with the US decades ago. Russia had launched the satellite Sputnik in 1957 before the US could do so.

~ 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.

~ 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.

~ 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 in 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.

~ Unlike a drug that is administered only to patients, vaccines are inoculated to a large number of people. In the case of this disease, specifically, everyone needs to be vaccinated.

WHY IT WON’T BE AVAILABLE ANYTIME SOON ATLEAST IN INDIA?

• The World Health Organisation (WHO) has said they don’t have enough information about the Russian vaccine to evaluate its potency against a raging Covid-19 pandemic.
• The vaccine candidates have not yet finished their final phase of the trial. Yet, a late Russian entrant claims to have completed all trials with Putin making the announcement of the first Covid-19 vaccine.
• AIIMS director Randeep Guleria said, “We will have to see critically whether it is safe and effective. There should not be any side effects of the vaccine and it should provide good immunity and protection. India has the capacity for mass production of the vaccine.”
• The doubt has not only been raised by global experts but also within Russia. A network of leading drug manufacturing companies, Acto (Association of Clinical Trials Organisation), which is based in Moscow too has sounded a caution note.
• Reports from Russia say Putin made the vaccine announcement and his government allowed its registration after a trial on only 76 people. This sample size is smaller than Patanjali’s — the Yoga trainer Ramdev-backed firm launched its immune-boosting Ayurvedic drug with an initial claim of curing Covid-19 patients.

While Putin claimed that the first dose of the vaccine is administered to his daughter caused significant rise in daughter’s antibodies after being inoculated, while the reports say that in volunteers the antibody count was below average.

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