Serum-Oxford COVID-19 Vaccine Gets DCGI Approval for Phase 2, 3 Clinical Trials in India

by StartupWorld Staff         

India-based top drug regulator, Drugs Controller General of India (DCGI) has given green signal to Serum Institute of India (SII) to perform phase 2 and phase 3 human clinical trials in India on the potential COVID-19 vaccine, developed by the University of Oxford, in the country- a senior government official said.

Over the matter, the senior government official said that after a rigorous evaluation, the DCGI granted permission to SII to conduct phase 2 and phase 3 clinical trials established on the Subject Expert Committee (SEC) recommendations.

As a speedy regulatory response, the proposal was preconceived in the SEC via a virtual meeting early the present week. On the Oxford University trial of phase 1 and phase 2 COVID-19 vaccine, after considering the generated data, the committee suggested passing approval to conduct phase 2 and phase 3 clinical trials of COVISHIELD (SII-ChAdOx1 nCoV-19) as a healthy adult are a major subject at risk in India, the government official stated.

Serum-Oxford COVID-19 Vaccine Gets DCGI Approval for Phase 2, 3 Clinical Trials in India

According to the study design, every subject will be regulated two doses 1 month apart (1st dose on Day 1 and 2nd dose on Day 29) following which the safety and resistance will be evaluated at predefined intervals, the government official said.

As per the government official, the pharma company has to submit safety data, estimated by the Data Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organization (CDSCO) earlier to it could proceed to the clinical trial of phase 3.

The previous week the media firm had reported that the domestic pharma giant had created an application to DCGI for approval to pass the phase 2 and phase 3 clinical trials conduct of coronavirus vaccine (ChAdOxlnCoV- 19) in India.

In India, the vaccine was manufactured by Serum under technical collaboration with Astra Zeneca/Oxford University and is called as COVISHIELD (SII-ChAdOx1 nCoV-19).

Presently, the Oxford University sponsored phase 2 and phase 3 clinical trials of the vaccine, which is ongoing in the UK. Besides, the phase 3 clinical trial is ongoing in Brazil, and South Africa is doing phase 1 and phase 2 clinical trials.

It is relevant to mark that COVISHIELD (SII-ChAdOx1 nCoV-19) vaccine restrain the replication-deficient simian adenovirus vector ChAdOx1, suppressing the Spike protein (structural surface glycoprotein) antigens of SARS-CoV-2.


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