03 Aug 2020: SII gets nod for Oxford COVID vaccine phase 2/3 trials
The Drugs Controller General of India (DCGI) gave the approval to SII late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee.
Here are more details.
Details: DCGI Dr. VG Somani gave nod to SII for trials
Government officials told PTI that SII had been granted the approval to conduct phase 2 and 3 clinical trials by the DCGI Dr. VG Somani.
A senior official said, "The firm has to submit safety data, evaluated by the Data Safety Monitoring Board, to the CDSCO before proceeding to phase 3 clinical trials."
The SII has partnered with AstraZeneca for manufacturing Oxford's vaccine candidate.
Fact: Phase 2, 3 trials underway in UK
Already, phase 2 and 3 clinical trials of the Oxford vaccine candidate, called AZD1222 (previously known as ChAdOx1 nCoV-19), are underway in the United Kingdom. In Brazil, phase 3 clinical trials are underway while phase 1 and 2 trials continue in South Africa.
Trial: SII to conduct observer-blind, randomized controlled study
The official said, "As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals."
They added, "[The SII] would conduct an observer-blind, randomized controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults."
Fact: 1,600 people above 18 years will participate in trials
According to a revised proposal submitted by SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, BJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences in Patna, PGIMER in Chandigarh, AIIMS-Jodhpur, etc.
Recent developments: SII had sent revised proposal last week
The SII had submitted its first application to the DCGI on July 25 to seek approval for phase 2 and 3 clinical trials.
The institute had then sent a revised proposal on Wednesday after it had been asked to do so, following deliberation over its application by the expert panel at the Central Drugs Standard Control Organisation (CDSCO).