There are no strong allergies caused by Sputnik V. [Representative image: Reuters]
The Drug Controller General of India (DCGI), on April 13, approved Sputnik V vaccine for emergency use, making it the third COVID-19 vaccine to be registered in India.
Dr Reddy's, which has collaborated with the Russian Sovereign Fund RDIF, conducted the bridge trial for Sputnik V and has applied for emergency use in India.
The Russian vaccine has been approved for use in countries in 59 countries so far.
Sputnik V is one of only three coronavirus vaccines registered by India’s regulatory authorities.
The roll out of Sputnik V will begin by end of April or early May, RDIF said.
Sputnik V will initially be imported before the local production kicks in.
India is currently using Serum Institute of India's Covishield and Bharat Biotech's Covaxin. The emergency approval of Sputnik V will help government efforts to scale up vaccination, as it struggles to contain the second wave of the pandemic. So far, India has given 100 million doses of COVID-19, but there were reports from many districts about shortages of vaccines.
“We appreciate the decision of India’s regulatory bodies to grant authorization for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production," said Kirill Dmitriev, CEO of the Russian Direct Investment Fund.
Dmitriev told CNBC-TV18 that they were working out pricing with the government. RDIF has hinted that the Sputnik V will be sold at less than $10 per dose. The vaccine has to be taken in two doses.
India is the leading production hub for Sputnik V. RDIF has reached agreements with the leading pharmaceutical companies in the country such as Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech aimed at production of more than 850 million doses per year, sufficient to vaccinate more than 425 million people around the world.
Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.
The Russian vaccine has efficacy of 91.6 percent and provides full protection against severe cases of COVID-19 as demonstrated by the data published in one of the leading medical journals The Lancet.
The Sputnik V vaccine is based on a proven and well-studied platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years.
Sputnik V uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades. There are no strong allergies caused by Sputnik V.
The storage temperature of Sputnik V at 2-8 C means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure.