Health

India to start trials of potential COVID vaccine 

DCGI gives nod to SII for conduct of Oxford COVID vaccine trials  

New Delhi: The Drugs Controller General of India (DCGI), on Monday, allowed the Serum Institute of India (SII) to conduct phase 2 and 3 human clinical trials in India on the potential COVID vaccine.

“After a thorough evaluation, the DCGI has given approval to SII to perform phase-II, III clinical trial based on the recommendations of the Subject Expert Committee (SEC),” a report by news agency ANI quoted official sources as saying.

“As a rapid regulatory response, the proposal was deliberated in the SEC through a virtual meeting earlier this week. And after considering the data generated on the vaccine in phase-1, 2 of the Oxford University trial, the committee recommended granting permission to conduct phase 2, 3 clinical trials of COVISHIELD (SII-ChAdOx1 nCoV-19) healthy adult subjects at risk in the country,” the official said.

Quoting a study, a report by DNA said that each subject will be administered two doses 4 weeks apart (First dose on Day 1 and Second dose on Day 29) following which the safety and immunogenicity will be assessed at predefined intervals.

The report quoted officials further saying that the firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organization (CDSCO) before it can proceed to phase-3 of the clinical trial.

The country’s top drug regulator had earlier made an application to DCGI for grant of permission to conduct phase 2, 3 clinical trials of coronavirus vaccine (ChAdOxlnCoV- 19) in India.

 

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