Russia's COVID-19 vaccine Sputnik V: Why India may have to wait longer

Russia claims to have developed a COVID-19 vaccine called Sputnik V. This is despite an incomplete mass clinical trials.

The COVID-19 vaccine is developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry. The vaccine called Sputnik V is a reference to the surprise 1957 launch of the world's first satellite by the Soviet Union.

Russian Health Minister Mikhail Murashko said that clinical trials of the vaccine were over. Medical workers and teachers will be the first to get the COVID-19 vaccine, he said.

Will the Russian vaccine come to India, which has recorded over 23 lakh COVID-19 cases and 46,000 deaths? There are several ways in which the vaccine can be made available in India, according to a report by The Indian Express.

In one way, the Central Drugs Standard Control Organisation (CDSCO) can ask Russia to conduct late-phase human trials on an Indian population, which consists of both phase-2 and phase-3 trials, said the report.

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Conducting late-phase human trials is a usual requirement for all vaccines developed outside of India. The step is important as a vaccine’s efficacy can differ in different population groups. For example: The route is being taken by vaccine candidate being developed by Oxford University, one of the six potential vaccines that have reached phase three clinical trials as per the World Health Organization’s (WHO) list. The Russian vaccine is not in this WHO's list.

Also, CDSCO can give emergency authorisation without late-phase trials, considering the rising COVID-19 cases in the country, the report suggested. For this, CDSCO can say it is satisfied with the safety and efficacy data produced during the human trials in Russia, and considering the extraordinary situation, it can grant approval for emergency use of the vaccine, as per the report.

Similar emergency approval was granted to use remdesivir drug as a therapeutic on COVID-19 patients, it said. However, this type of approval is not likely to be given for the use of the Russian vaccine, as unlike a drug that is administered only to patients, vaccines are inoculated to a large number of people. In the case of COVID-19, everyone needs to be vaccinated. Therefore, the risks involved are much higher, the report said.

Another issue in providing the Russian vaccine to Indians is the absence of any agreement for its production in the country right now, added the report.