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India’s drugs controller approves Covid vaccine Sputnik V for emergency use
Dr Reddy’s labs, which is conducting clinical trials in India on behalf of the makers of Sputnik V, said in a statement on Tuesday that they had received the national regulator’s emergency use approval. The company will import the vaccine for use in India
The drugs controller general of India (DCGI), Dr VG Somani, on Tuesday approved Russian Covid-19 vaccine, Sputnik V, for emergency use in India, a day after regulator’s subject expert committee recommended that there was enough data to support that the vaccine was fit to be used.
Dr Reddy’s labs, which is conducting clinical trials in India on behalf of the makers of Sputnik V, said in a statement on Tuesday that they had received the national regulator’s emergency use approval. The company will import the vaccine for use in India.
“We are very pleased to obtain the emergency use authorisation for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against Covid-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population,” said GV Prasad, managing director, and co-chairman, Dr Reddy’s Labs.
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In September 2020, Dr. Reddy’s had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and distribute the vaccine in India. In addition to the trials conducted in Russia by RDIF. Phase 2/3 clinical trials of the vaccine were carried out by Dr. Reddy’s in India.
Sputnik V is now approved for use in 60 countries around the world. It ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators. Sputnik V uses two different vectors for the two shots in a course of vaccination. The efficacy of Sputnik V was determined to be 91.6% as per a published article in the Lancet.
The vaccine’s efficacy is based on the final assessment of clinical trials in Russia, where roughly 20,000 people were part of the phase 3 clinical trials. In India, the vaccine is being tested in 1,600 people in a phase 2/3 trial meant as a “bridging study” that all foreign-made pharmaceutical products need to undergo.
The bridging study in India is being carried out by Dr Reddy’s labs, which also has a contract to distribute 100 million doses once the final approvals are in place.
“India is the most populated country to register the Russian vaccine. Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40% of the global population. The vaccine has been registered in India under the emergency use authorisation procedure based on results of clinical trials in Russia as well as positive data of additional Phase 3 local clinical trials in India conducted in partnership with Dr. Reddy’s Laboratories. India is the leading production hub for Sputnik V. RDIF has reached agreements with the leading pharmaceutical companies in the country… aimed at production of more than 850 million doses per year,” said RDIF in a statement.
In addition to Dr Reddy’s, RDIF has tied up with five Indian pharma companies. All of the other deals are for production of the vaccine in India
The others include Gland Pharma, Hetero Biopharma, Panacea Biotec and Virchow Biotech.
Developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, Sputnik V is based on an adenovirus platform, similar to the Oxford-AstraZeneca dose, but it uses different adenoviruses that its makers say will help boost its efficacy.
