SPUTNIK V COVID-19 VACCINE GETS APPROVAL IN INDIA

Paving the way for a third Covid-19 vaccine to be available in the country, the Drugs Controller General of India (DCGI) has granted permission for restricted emergency use of Russia’s Sputnik V jab. It is now only a matter of time before India rolls out the Sputnik V vaccine, developed by Russia’s Gamaleya Institute and funded by the Russian Direct Investment Fund. The vaccine is the only one other than that of Pfizer and Moderna to demonstrate efficacy of more than 91.6 per cent against Covid-19 when taken in two doses, 21 days apart. This was found in interim results of Phase 3 trials conducted in Russia on more than 20,000 volunteers aged above 18 years. WHAT DOES THE DATA SAY IN RUSSIA? According to data published in The Lancet, vaccine efficacy was 91.8 per cent in participants older than 60 years. There were no cases in the vaccine group while 20 cases in the placebo group with moderate or severe Covid-19 were confirmed at least 21 days after the first dose. Thus, the vaccine efficacy against moderate or severe Covid-19 was shown as 100 per cent. A bridging study in India has been done on 1,300 participants. The study is yet to be completed. Sources said it would be complete by June 2021 and only then the efficacy data would be revealed. STORAGE AND LOGISTICS This vaccine can be stored in two forms. In the liquid form, it requires a temperature of -18 degrees C and in the powdered form it requires a temperature storage of 2-8 degree Celsius, meaning it can be stored in conventional refrigerators and does not require an additional cold-chain infrastructure. PRICE The price of Sputnik V is less than $10 per shot. In India, Covishield and Covaxin are being sold at Rs 250 a dose at private facilities and for free at government facilities. HOW IS IT ADMINISTERED? The vaccine is given (0·5 mL/dose) intramuscularly in a prime-boost regimen. But unlike other similar vaccines, the Sputnik jab uses two slightly different versions for the first and second dose. The first dose (rAd26) is a different vector and the second dose is (rAd5). But, both vectors carry the gene for full-length SARS-CoV-2 glycoprotein or protein S. They both target the coronavirus’s distinctive “spike”, but use different vectors – the neutralised virus that carries the spike to the body. The idea is that using two different formulas boost the immune system even more than using the same version twice. VERY FEW ADVERSE EVENTS So far, no serious adverse effects related to Sputnik V vaccination has been reported, except grade 1 events such as flu and headache. Some side effects to a vaccine are expected, but these are usually mild, including a sore arm, tiredness and a bit of a temperature. There were no deaths or serious illnesses in the vaccinated group linked to the jab. Data in The Lancet shows that of the 19,866 who got two doses, 70 episodes of serious adverse events were seen but were not considered related to vaccination. During the study, four deaths were recorded: three in the vaccine group and one in the placebo group. No vaccine-related deaths were reported. In the vaccine group, one death was associated with fracture of the thoracic vertebra and the other two were associated with Covid-19. Among them, one patient had a severe cardiovascular background and developed symptoms on Day 4 after first dose while another patient with endocrinological comorbidities developed symptoms on Day 5 after first dose. In the placebo group, the death was associated with haemorrhagic stroke. PRODUCTION Last week, the Russian Direct Investment Fund (RDIF) announced production agreements with five Indian manufacturers for more than 400-500 million doses of the Sputnik V Covid-19 vaccine a year. In total, production capacity for more than 700 million people have been secured by 10 countries. Dr Reddy’s Laboratories already has a tie-up for the distribution of Sputnik V. The following contracts were also signed: – Virchow Biotech: 200 million doses for 100 million people – Stelis Biopharma: 200 million doses for 100 million people – Gland Pharma: 252 million doses for 126 million people – Panacea Biotec: 100 million doses for 50 million people – Hetero: 100 million doses for 50 million people The vaccine is presently being used in 60 countries. In addition to India, RDIF has signed a number of contracts for production of Sputnik V at around 20 manufacturing sites in more than 10 countries, including Brazil, South Korea, China, Italy, Belarus and Kazakhstan.