Russian COVID-19 vaccine Sputnik V has been approved for emergency use authorisation in India, the Russian Direct Investment Fund (RDIF) said in a press release on Tuesday, 13 April. With this, India has become the 60th country to approve the vaccine.
The RDIF announced on Tuesday that Drug Controller General of India (DCGI) has approved the use of the vaccine against coronavirus in India. On Monday, 12 April, the Subject Expert Committee (SEC) approved Dr Reddy's application for emergency use authorisation to the vaccine. With the SEC’s recommendation, the next step required before a rollout out across the country was an approval by the DCGI.
Dr Reddy's Laboratories Ltd has also announced that it has received the permission from the DCGI to import the Sputnik vaccine to India for restricted use in emergency situations.
This comes as the country faces a massive surge in cases in its second wave and amid reports of vaccine shortages from several states.
Till now, India had two approved vaccines against coronavirus – Bharat Biotech's Covaxin and Serum Institute of India's Covishield.
How does Sputnik V vaccine work?
Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the established human adenoviral vector platform.
The Oxford-AstraZeneca vaccine, being manufactured by Serum Institute (SII) as ‘Covishield’, is also a viral vector vaccine.
What is the reported efficacy of Sputnik V?
The vaccine has been reported to have an efficacy of 91.6 percent.
Where is Sputnik V vaccine manufactured?
The Russian Direct Investment Fund (RDIF) has tied up with a host of Indian pharmaceutical players including Hetero Biopharma, Gland Pharma, Stelis Biopharma and Vichrow Biotech for the production of vaccine doses. With a production capacity of approximately 850 million doses in India, Sputnik V is expected to boost the fight against COVID-19.
How many doses of Sputnik V do I need to take?
A person needs to take two doses of Sputnik V vaccine to complete one cycle.
How is the vaccine to be administered?
According to the Health Ministry, the vaccine is indicated for active immunisation to prevent COVID-19 in individuals of the age of 18 and above.
The ministry directed that the vaccine should be administered intramuscularly in two doses of 0.5 ml each in an interval of 21 days.
How much is it likely to cost?
This is not clear yet. Watch this space for updates. In November 2020, the RDIF had said they would price their vaccine at affordable rates for international markets at less than $10, or roughly Rs 740, per dose.
This may be cheaper than Moderna or Pzifer, but is still more expensive as compared to Covishield, which Serum Institute is selling to the government for Rs 200 per dose, excluding taxes, and Covaxin, which Bharat Biotech has priced at Rs 295 per dose.
What are the expected side effects?
"No unexpected adverse events were identified as part of the research," the vaccine developers said, in November 2020.
However, those vaccinated suffered short-term effects including fever, weakness, fatigue, and headache.
How should the vaccine be stored?
It can be stored at -18°C, the Health Ministry said.
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