India gets 3rd COVID-19 vaccine, DGCI approves Russian-made Sputnik V

Drug Controller General of India (DGCI) has approved Russian COVID-19 vaccine Sputnik V for emergency use in India. With this, India has become the 60th country to approve this vaccine.

The Russian Direct Investment Fund (RDIF) announced on Tuesday that DCGI has approved the use of the vaccine against COVID-19 in India. On Monday, 12 April, reports said that 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.

Sputnik V is now the third vaccine to get an emergency authorisation in India after Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin.

The vaccine has been registered in India under the emergency use authorisation procedure based on results of clinical trials in Russia, interim analysis of which an efficacy of 91.6%, as well as data from RDIF's Indian partner Dr Reddy's additional phase 2 and 3 clinical trials in India.

While Dr Reddy’s Laboratories is expected to distribute up to 250 million doses of the vaccine in India, RDIF also has manufacturing agreements with Gland Pharma, Hetero Biopharma, Stelis Biopharma, Virchow Biotech and Panacea Biotec to produce more than 850 million doses of Sputnik V in the country for the world.

Sputnik V works on the principle of a weakened Covid virus delivering parts of a pathogen that triggers an immune response in the body.

Number of doses?
A person needs to take two doses of Sputnik V vaccine to complete one cycle.

Cost?
The prices of the vaccine are being negotiated between the Indian government and companies, with RDIF earlier announcing that Sputnik V will be prices at lower than $10 ( ₹750) per dose.

This may be cheaper than Moderna or Pzifer, but is still more expensive as compared to Covishield, which SII is selling to the government for ₹200 per dose, excluding taxes, and Covaxin, which Bharat Biotech has priced at ₹295 per dose.

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.

Storage?
It can be stored at between 2 and 8 degrees Celsius (between 35.6 and 46.4 degrees Fahrenheit), the vaccine manufacturers said.
The development comes at a time when some states are facing shortages of Covishield and Covaxin and Covid-19 cases are surging amid a second wave. Both Serum Institute and Bharat Biotech, however, are struggling to expand capacity and have sought government aid for it.

Source: livemint.com, thequint.com, ndtv.com

Written by Siddhant Sharma