Yuva - India

Authorization for Russia’s Sputnik V vaccine- All you need to know

On Thursday India reported the highest-ever single-day rise in the number of COVID-19 patients with over 2 lakh cases. Recently India also took the second position by overtaking Brazil to become the world’s second-most affected country. In the wake of the increasing COVID-19 situation, India’s DGCI (Drugs Controller General of India) approved the 3rd vaccine Sputnik V to be available in the Indian market after Covaxin and Covishield.

The GDCI first approved two Covid-19 vaccines for emergency use in the country on 3rd January. These were India’s indigenous vaccine Covaxin, which is developed by Bharat Biotech, and Covishield, which is developed by the Oxford-AstraZeneca master seed and manufactured by the Serum Institute of India (SII).

The Russian vaccine Sputnik V is developed by GRI (Gamaleya Research Institute) and the ministry of defense, Russia. Whereas the Russian Direct Investment Fund (RDIF), the sovereign wealth fund of the country, is developing partnerships with foreign partners for the production and supply of the Sputnik V vaccine.

Some of the Indian pharmaceuticals and RDIF have already agreed to produce over 850 million doses of the vaccine annually in India. Dr. Reddy’s Laboratories (DRL), a Hyderabad-based major pharmaceutical company, has become the marketing partner of the Spitink-V vaccine in the country. DRL said that the vaccine would be available in the Indian market by this quarter via importation from Russia, and the availability would take place in the next quarter once manufacturing would be started in the country. Also, 60-70 percent of the vaccine’s global production will take place in India, stated the DRL.

However, the vaccine’s availability in India depends on factors like the number of doses that the government wants to procure, the price, and India’s capacity in terms of the cold chain system to distribute those vaccines. The price is yet to be decided. Dr. Reddy’s Laboratories (DRL) will use its cold chain infrastructure besides the government’s cold chain infrastructure for last-mile availability.

Dr. Reddy’s Laboratories sought approval to market the Sputnik V vaccine on 19th February for the first time. However, the approval was not cleared by the authority citing a lack of data. The company was asked to reapply for approval with proper immunogenicity data. They had conducted phase-2/3 clinical trials on about 1,500 people in India, though phase-3 trials were still underway. American pharmaceutical company Pfizer had also applied for approval of its mRNA vaccine in India. Later on, Pfizer withdrew its emergency application after the authority asked for detailed data and studies.

“We have tested the cold chain in simulation scenarios from Hyderabad to as far as Manipur in the northeast, Ladakh in the north, and Tamil Nadu in the south,” Deepak Sapra, CEO (API and Phar­maceutical Services), DRL said. Often a domestic and bridging study will be required for a vaccine maker to be considered for approval in the country by the government of India.

Besides Dr. Reddy’s, RDIF also agreed with Hetero Biopharma, Gland Pharma, Panacea Biotec, Virchow Biotech, Stelis Biopharma, and Shilpa Medicare to manufacture around 850 million doses of Sputnik V in the country.

Currently, the vaccine is said to have 91.6 percent efficacy; it claims to be the highest among Covid vaccines available in India, requires a temperature of -18 degree C to -22 degree C to remain stable.

The developers of the Russian vaccine Sputnik V said on Wednesday that its jab does not cause blood clots, one of the reasons, several countries in the west did not approve the rollout of the vaccine.

Recently the United States recommended a pause in rolling out of the vaccine made by Johnson & Johnson because it is seen that one person in seven million Americans died from a rare type of blood clot in the brain following inoculation. South Africa has also suspended the use of the Johnson & Johnson vaccine in a similar line to that of the US. This is not the first time a sudden change in the vaccination strategy has been carried out by South Africa. The country also abandoned its idea to use the AstraZeneca vaccine for its health workers due to a preliminary test that showed that it gave minimal protection against mild to moderate cases. On Wednesday Denmark became the first country in Europe to suspend the AstraZeneca vaccine following several incidents of serious cases of blood clots that were reported after inoculation.

India has become the 60th country to approve the rollout of the Sputnik V vaccine, Also India is the most populated country to provide emergency use authorization (EUA) to the vaccine. Other countries which approved the vaccine are Argentina, Bolivia, Hungary, UAE, Iran, Mexico, Pakistan, Bahrain, and Sri Lanka.

A steep increase in the number of COVID-19 cases has become a major concern for India, also many states going through the election process increases the risk of aggravating the situation manifold. The Vaccine crisis in Maharashtra and other states made the situation even worse. In such a state of affairs, the availability of the Sputnik V vaccine in the Indian market might bring some respite.

Sangita Paul

Intern, Goa Chronicle

DISCLAIMER: This article reflects author’s view point. Goa Chronicle may or may not subscribe to views of the author

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