NEW DELHI: The Drugs Controller General of India has allowed the Serum Institute of India (SII) to conduct Phase-2 and Phase-3 human clinical trials of a potential Covid-19 vaccine, developed by the Oxford University.
The SII has a manufacturing partnership with AstraZeneca, which has got the licence for the vaccine. The experimental vaccine, AZD1222, produced promising immune response in early-stage clinical trials, the Lancet said two weeks ago, raising hopes it would be available for public use by the year-end.
Sources said the subject expert committee of the Central Drugs Standards Control Organisation gave its nod for the trial on Sunday evening after evaluating it thoroughly. According to the study design, each subject will be administered two doses of the vaccine four weeks apart (first dose on Day 1 and the second dose on 28th day) following which the safety and immunogenicity will be assessed at predefined intervals.
SII has to submit safety data of Phase-2, evaluated by the Data Safety Monitoring Board, to the regulator before it can proceed to Phase-3. Currently, Phase 2, 3 clinical trials of the Oxford vaccine are in the UK, while Phase-3 clinical trial has started in Brazil. In South Africa, the vaccine is being assessed in Phase-1 and Phase-2 trials. This vaccine candidate uses a common cold virus, which has been weakened so that it can’t cause any disease in humans, and is genetically modified to code for the spike protein of the SARS-CoV-2 virus.
India trial is crucial as it will reveal how pre-existing immunity levels will impact response to the Covid-19 vaccine