NewsSerum Institute of India just got regulatory nod for...

Serum Institute of India just got regulatory nod for phase 2,3 human trials of ‘Covidhield’


Potential coronavirus vaccine jointly developed by AstraZeneca and the University of Oxford for India just got the regulatory nod for stage 2 and 3 human clinical trials by the Serum Institute of India (SII).

The Drug Controller General of India (DCGI), late on Sunday, permitted the SII to conduct the next advanced stage of the trial on human, government officials told news agency PTI.

Drugs Controller General of India has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca #COVID19 vaccine (COVISHIELD) in India.@PMOIndia @drharshvardhan @AshwiniKChoubey @UniofOxford

— Ministry of Health (@MoHFW_INDIA)
August 3, 2020

Serum Institute of India just got regulatory nod for phase 2,3 human trials of ‘Covidhield’

“The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials,” a senior official told, CNN News18 reports.

The approval dubbed ‘rapid response’ arrived after carefully considering the phase 1 and 2 results of the same vaccine.

The trail will involve jabbing the adult candidates with two doses of the COVID-19 vaccine in a gap of four weeks; the first dose on day one and the second dose on day 29th. Vital data involving immune response and anti-viral activity will be tested at ‘predefined intervals.’

Over a thousand adult will be participating in trials across 17 states, media reports confirm. The Serum Institute of India, which is making the Oxford-made vaccine with AstraZeneca applied for DGCI approval last month.

The Oxford-vaccine has already entered the stage 2 and 3 human clinical trail in the United Kingdom and other other nations at various stages.

Over a hundred vaccines are currently under development in various parts of the world, racing to land on the first successfully tested jab to immunize against the novel coronavirus that is ravaging the planet.

The Oxford University vaccine in Britain was said to have triggered a strong immune response in clinical trials. “They’re extremely promising and we believe the type of response that may be associated with protection,” Prof Andrew Pollard, from the Oxford research group told the BBC in July.


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