Representative image: Sputnik V
The Drug Controller General of India (DCGI) approved the Sputnik V COVID-19 vaccine for emergency use on April 13. This is the third vaccine, and the first foreign jab, against the novel coronavirus to have been granted emergency use authorisation in the country after Covishield, developed by Oxford University-AstraZeneca and manufactured by the Serum Institute of India (SII), and Bharat Biotech’s Covaxin.
The timing of its entry is crucial as India has opened up its vaccination drive for all citizens above the age of 18 from May 1. The immunisation drive is currently restricted to only citizens aged above 45.
Indian pharmaceutical company Dr. Reddy's Laboratories has collaborated with the Russian sovereign fund Russian Direct Investment Fund (RDIF) to conduct the bridge clinical trials for Sputnik V in India.
India is the 60th country to approve the vaccine. According to RDIF, the Sputnik V’s rollout in India will begin by end of April or early May.
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Here are some of the key questions answered:
Who has developed this vaccine?
Sputnik V has been developed by the Russian state-backed Gamaleya Research Institute of Epidemiology and Microbiology. The "V" in the name is the alphabet V, not the Roman numeral for five. It was registered in Russia in August 2020 as Gam-COVID-Vac. Sputnik V needs to be stored at 2-8 degrees Celsius. This means it can be stored in a normal refrigerator and there’s no need to invest in additional cold-chain infrastructure.
How is it different from other COVID-19 vaccines?
Sputnik V is an adenovirus viral vector vaccine. This type of vaccine contains viruses engineered to carry the coronavirus genes. Some viral vector vaccines enter cells and cause them to make viral proteins. Others slowly replicate, carrying virus proteins on their surface.
How many doses?
Just like Covishield and Covaxin, people will get two doses of the vaccine. These doses will have to be administered 21 days apart. These will be normal muscle injections.
How effective is it?
Sputnik V has a proven efficacy rate of 91.5 percent, which is the highest after Moderna and Pfizer-BioNTech’s candidates. Bridge trials were conducted in India before it was given approval. Side effects after the use of the Sputnik V vaccine are reported in 0.1 percent of cases, Russian state-backed news agency TASS cited
the country’s Health Minister Mikhail Murashko as saying on April 6.
How much does it cost?
The cost of Sputnik V in the international market is around $10 (Rs 750) per shot. However, the price in India is unclear at this moment. The government is reportedly in the process of negotiating the pricing with the manufacturer.
Why is the approval significant?
The vaccine has been granted emergency use authorisation at a time when India is facing the second wave of COVID-19 cases. Many states have reported a shortage in vaccine doses even as India is hoping to scale up the vaccination drive. The inflow of the Sputnik V vaccine doses is likely to ease this shortage and boost the nationwide vaccination drive.
Who is manufacturing it?
Dr. Reddy’s Laboratories is expected to distribute up to 250 million doses in India, importing the vaccines initially to meet the demand in India. RDIF also has manufacturing agreements with Gland Pharma, Hetero Biopharma, Stelis Biopharma, Virchow Biotech, and Panacea Biotec to produce over 850 million Sputnik V doses in India. These are for distribution across the world. However, production is yet to start at Hetero Biopharma and Panacea Biotec. Other partners are likely to start production by September.
Where is it currently being administered?
Besides early use in Russia, Sputnik V is being administered in Argentina, Bahrain, Egypt, Hungary, Iran, Jordan, Mauritius, Mexico, Morocco, Pakistan, Panama, the Philippines, Sri Lanka, United Arab Emirates, and Vietnam, among other countries.Click here for Moneycontrol’s full coverage of the coronavirus pandemic