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Sputnik-V approval likely to be sought by March

sputnik-v approval concept
Image credit: Yalç?n Sonat / 123rf

Dr Reddy’s Laboratories Ltd. is expected to seek Sputnik-V approval by next month. Emergency use authorisation for use of the Russian-manufactured COVID-19 vaccine is being sought following research suggesting the vaccine candidate to be effective.

A press release, carried by Health Issues India earlier this week, outlined that “in the interim efficacy analysis of the randomised, double-blind, placebo-controlled clinical trial, where data on 19,866 volunteers were included in the efficacy analysis (14,964 of whom received the vaccine and 4,902 the placebo), the two-dose treatment of Sputnik V administered 21 days apart demonstrated efficacy of 91.6% against COVID-19. The calculation is based on the analysis of 78 confirmed cases of COVID-19 identified in the placebo group (62 cases) and in the vaccine group (16 cases). Sputnik V generated a robust humoral and cell mediated immune response.” 

Sputnik-V approval is consequently on the cards once the application is put in. The application could come within days. The Russian Direct Investment Fund expects 300 million doses of Sputnik-V could be manufactured in India this year.

Last year, All India Institute of Medical Sciences (AIIMS) director Dr Randeep Guliera told The Hindustan Times that “if Russia’s vaccine is successful, then we will have to see critically whether it is safe and effective. There should not be any side effects of the vaccine and it should provide good immunity and protection. India has the capacity for mass production of the vaccine.” 

Inoculations with the vaccine have already reached more than a million in Russia. Sputnik-V has already secured emergency use authorisation in Algeria, Argentina, Bolivia, Mexico, and Serbia.

India’s own vaccination campaign against COVID-19 is underway. Two vaccines are approved for use: that developed by drugmaker AstraZeneca and the University of Oxford and indigenously-produced Covaxin by Bharat Biotech. Pfizer and BioNTech have sought approval for their own vaccine candidate. India has inoculated four million people in eighteen days, faster than any other country in the world. 

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