Updated: May 14, 2021 2:32:56 pm
Sputnik V, the vaccine against Covid-19 developed by Russia, has been cleared for emergency use by the Drugs Controller General of India, the country’s drug regulator. On Monday, an expert panel recommended it for emergency use in India. It is now the third coronavirus vaccine to get emergency use approval, after Covishield (Serum Institute of India) and Covaxin (Bharat Biotech).
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The Sputnik V vaccine
The Sputnik V vaccine, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, uses two different viruses that cause the common cold (adenovirus) in humans. The adenoviruses are weakened so they cannot replicate in humans and cannot cause disease. They are also modified so that the vaccine delivers a code for making the coronavirus spike protein. This aims to ensure that when the real virus tries to infect the body, it can mount an immune response in the form of antibodies.
Sputnik uses a different vector for each of the two shots in a course of vaccination. This provides immunity with a longer duration than vaccines using the same delivery mechanism for both shots, according to the Russian Direct Investment Fund (RDIF). The two shots are given 21 days apart.
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Sputnik V is to be stored at -18°C in its liquid form. However, in its freeze-dried form, it can be stored at 2-8°C, in a conventional refrigerator without any need to invest in additional cold-chain infrastructure. Sputnik V is approved for use in over 55 countries with a total population of over 1.5 billion people, according to RDIF. It has proposed to price the vaccine at less than $10 per shot.
Dr Reddy’s Laboratories, based in Hyderabad, had sought the government’s approval for the vaccine to be used in India. The RDIF partnered with Dr Reddy’s in September 2020 to conduct clinical trials in the country. On Monday, the Drugs Controller General of India’s subject expert committee (SEC) took up the Sputnik V application for emergency use authorisation and gave the go-ahead. DCGI had earlier sought additional data from the drugmaker.
Five other Indian companies have partnered with RDIF for Sputnik V. The others are Gland Pharma, Hetero Biopharma, Virchow Biotech, Panacea Biotec and Stelis Biopharma, the biopharamaceutical arm of the Bengaluru-headquartered Strides Pharma Science. Together, these partnerships are expected to take India’s capacity to make this vaccine to over 600 million doses a year.
Launched in August last year by Russian President Vladimir Putin, the vaccine had then come under criticism from the scientific community over the apparent haste. Since then, however, phase 3 trials conducted in Russia, with the results published in The Lancet, have found it has an efficacy of 91.6%. In India, Dr Reddy’s conducted a bridging study after which it applied for emergency use approval.
Professor Ian Jones, University of Reading, and Professor Polly Roy, London School of Hygiene & Tropical Medicine, UK (who were not involved in the study), had then written in The Lancet: “The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of Covid-19.”
Trial participants were given the first dose (rAd26-) followed by a booster dose (rAd5-S) 21 days later. The authors said that using a different adenovirus vector may help create a more powerful immune response (compared with using the same vector twice), as it minimises the risk of the immune system developing resistance to the initial vector.
The study found no strong allergies caused by Sputnik V.
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