Serum-Oxford COVID-19 vaccine gets DGCI nod for Phase 2, 3 clinical trials in India

Serum Institute of India (SII) has received Drugs Controller General of India (DCGI) approval to conduct phase 2 and 3 human clinical trials of its potential COVID-19 vaccine in India.

While speaking to ANI, a government official said that the Pune-based drug firm has been granted permission on the recommendations of the Subject Expert Committee (SEC). 

The official told ANI: “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”. 

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Earlier on July 25, the Serum Institute had submitted its application to the DCGI, seeking permission to perform phase 2 and 3 human clinical trials of the potential vaccine.

According to the study design, the drug-firm will be administrating each subject with two doses four weeks apart. The researchers will be assessing the safety and immunogenicity at predefined intervals. 

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1,600 participants to be enrolled

The government official is reported to have said that the pharmaceutical firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the Central Drugs Standard Control Organisation (CDSCO) before it can proceed to phase-3 of the clinical trial.

The pharmaceutical company will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine the safety and immunogenicity of ‘Covishield’. 

The domestic pharma giant has partnered with British drugmaker AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.

As per a Lancet medical journal report, a vaccine candidate developed at the University of Oxford has shown encouraging results and it appears to be ‘safe, well-tolerated, and immunogenic’. Last month, Oxford University also announced satisfactory progress with its COVID-19 vaccine, making it a lead one among the dozens of vaccine candidates being developed around the world. The clinical trials of a potential COVID-19 vaccine on humans began in April.

(With ANI inputs) 

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