13 Apr 2021: India to get limited doses of Sputnik V by April-end
Sputnik V, the Russia-made coronavirus vaccine, will be manufactured in India by five pharmaceutical firms. It is estimated that 850 million doses will be produced yearly.
However, India will get only limited doses of the vaccine by April-end.
The vaccine is the third one to get the Drugs Controller General of India's (DCGI) nod. India is the 60th country to approve the vaccine.
Series of events: Yesterday, SEC recommended granting approval to the vaccine
On Monday, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) recommended granting approval to the vaccine.
Last year, Hyderabad-based Dr. Reddy's Laboratories had joined hands with the Russian Direct Investment Fund (RDIF) for conducting clinical trials of the vaccine.
Separately, the vaccines developed by Zydus Cadila, Biological E, and Gennova are also in advanced trials in India.
Efficacy: The vaccine was found to be 91.6% effective
The two-shot vaccine was found to be 91.6% effective in preventing the disease. Only the vaccines developed by Moderna and Pfizer were judged to more effective than this shot.
The doses of 0.5 ml each have to be injected to those aged 18 and above in an interval of 21 days.
The vaccine has to be stored at -18 degree Celsius.
Details: SEC reviewed application of Dr. Reddy's Laboratories during two meetings
Notably, SEC had deliberated on the application during two meetings on April 1 and February 24.
The body has directed the firm to furnish revised factsheets to CDSCO after including the latest safety and efficacy data.
The pharmaceutical company has also been asked to submit safety, efficacy, and immunogenicity data from trials that are underway in Russia and India for review, as and when available.
Statement: 850mn doses can vaccinate over 425mn globally: RDIF CEO
Kirill Dmitriev, the CEO of the RDIF, noted that India is a vaccine-manufacturing hub and its capabilities will be used to provide relief to the world.
"Over 850 million doses of Sputnik V are going to be produced in India annually sufficient to vaccinate more than 425 million people around the world," he said.
He also hailed the approval of the vaccine.
Figures: India is struggling to contain the second wave of coronavirus
The approval comes at a time when a precarious second coronavirus wave is ripping India apart. Just yesterday, 1.6 lakh fresh coronavirus infections were reported, swelling the nationwide tally to 1.36 crore. During the 24-hour-long period, 879 more patients succumbed to coronavirus-linked complications.
Since the beginning of the vaccination drive on January 16, 10,85,33,085 have received the doses, government data shows.