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India overtakes Brazil as world's second worst-hit country by COVID-19 Drug regulatory authority approves Russian vaccine Sputnik V for emergency use
Published in The Saudi Gazette on 12 - 04 - 2021

As India battles the second wave of coronavirus amid an acute shortage of vaccines, the expert panel of the country's drug regulator on Monday approved the use of Russia's Sputnik V COVI-19 vaccine, according to local reports.
Drugs Controller General of India (DCGI)'s Subject Expert Committee (SEC) met on Monday to take up Sputnik V application for Emergency Use Authorization in India.
DCGI will now consider SEC recommendation for the third COVID-19 vaccine to be available in India amid vaccine shortage. The first two are Serum Institute of India's locally-made Oxford COVID-19 vaccine "Covishield" and Bharat Biotech's indigenously manufactured Covaxin.
The vaccine would be imported from Russia for emergency use in the country, they said.
India is currently carrying out a nationwide mass vaccination campaign that commenced on Jan. 16, 2021.
Last Friday, the drug regulatory authority sought additional data from drugmaker Dr. Reddy's Laboratories on its Sputnik V COVID-19 vaccine trial, in its second such request after an initial evaluation in February.
The decision comes as India reported a record 168,912 COVID-19 infections overnight, data from the health ministry showed on Monday, overtaking Brazil to become the second-most affected country globally by the coronavirus.
India's overall tally reached 13.53 million, surpassing Brazil's 13.45 million cases, according to data compiled by Reuters. The United States led the global tally with 31.2 million cases.
Deaths in India stood at 904, taking the total to 170,179, data showed.
The new wave, known to have increased transmissibility, has decreased the recovery rate of the country which currently stands at over 90 percent. It used to be more than 97 percent, one of the highest in the world in February.
Maharashtra, Chhattisgarh, Uttar Pradesh, Karnataka, Delhi, Tamil Nadu, Madhya Pradesh, Gujarat, Haryana, Rajasthan, Punjab, Kerala, Telangana, Uttarakhand, Andhra Pradesh and West Bengal are displaying a rising trend in the number of new cases in a single day. Uttarakhand, which is hosting the Kumbh Mela in Haridwar, witnessing huge crowds, is also one of the 16 states spiraling the virus out of control in the country.
The committee had earlier asked the company to submit a comparative analysis of late-stage immunogenicity data from both its Indian studies and an ongoing Russian study, as well as data on serious adverse events and positive cases reported to date. On Sunday, top government sources told news agency ANI that by end of the third quarter of this year, India will be getting vaccines from five additional manufacturers. India currently manufactures Covishield and Covaxin. — Agencies


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