Drugs Controller General of India grants permission to Serum Institute of India to manufacture its COVID-19 vaccine ‘Covishield’. The Pune-based company earlier stated that ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults aged 56-69 and those over 70 years of age.
India joins the league of countries that have approved their own vaccines against coronavirus. The two vaccines that have been granted nod for emergency use are -- AstraZeneca-Oxford and Bharat Biotech.
Serum Institute of India (SII) Chief Executive Officer Adar Poonawalla on Sunday assured that the Covishield vaccine, which has received approval for restricted emergency use, is "very safe".
Taking to Twitter, Congress MP Shashi Tharoor said, "The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous."
Hours after India's drugs regulator approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country, Union Health Minister Dr. Harsh Vardhan on Sunday called it a "watershed moment" in India’s famed battle against COVID-19.
As India gears up for the world's largest vaccination programme, the Drugs Controller General of India (DCGI) on Sunday quelled rumours surrounding the COVID-19 vaccines regarding impotency, rubbishing such speculations as "absolute nonsense".
The approved vaccines will be first offered to one crore healthcare workers, along with two crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.
Poonawalla'' remarks came soon after after India's drugs regulator, Drug Controller General of India (DCGI) approved Covishield for restricted emergency use.
Covid-19 vaccines- COVAXIN and COVISHIELD have been cleared for restricted use in emergency situation, DCGI, V G Somani said.
The expert panel has recommended granting permission for restricted emergency use of 'Covaxin' in "public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains.
In a significant development, Drugs Controller General of India (DGCI) on Sunday (January 3) formally approved Oxford-AstraZeneca's Covishield and Bharat Biotech's Covaxin for use in India.
The Drug Controller General of India (DCGI) will address a press conference on Sunday (January 3) at 11 am and it is being expected that the drug controller watchdog may announce the approval of emergency use of two vaccines.
As the nation conducted a dry run of the vaccination process ahead of an expected launch of a vaccine against coronavirus, Uttar Pradesh Chief Minister Yogi Adityanath Dry said he is confident that they will be able to bring the vaccine around Makar Sankranti and defeat coronavirus.
Given that India has set the goal of vaccinating 30 crore people with Covid-19 jabs by July, can the country procure enough doses to fulfil that goal?
As India gears up to launch the world's largest immunisation drive, almost all states and Union Territory (UT) governments, including the national capital, conducted a dry run on Saturday to assess their ability and readiness to administer Covid-19 shots to hundreds of millions of people, including many in remote corners of the country.
An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended to grant emergency use authorisation for the Oxford COVID-19 vaccine Covishield, being manufactured by Serum Institute of India, sources said on Friday.
The analysis of the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech is still being conducted by regulator Central Drug Standard Control Organisation's (CDSCO) Subject Expert Committee and their next meeting will be held on January 1.
The Serum Institute of India (SII) has submitted additional data required by the Drug Controller General of India (DCGI) for determining the safety and immunogenicity of its Covid-19 vaccine candidate, Covishield, sources privy to the development told IANS.
Covishield is logistically feasible for distribution in India's both urban and rural parts as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country.
Covishield is logistically feasible for distribution in India's both urban and rural parts as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country.
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