NEW DELHI: The Drugs Controller General of India (DCGI) has allowed the Serum Institute of India (SII) to conduct phase 2 and 3 human clinical trials of a potential Covid-19 vaccine developed by the Oxford University, UK, the Centre said on Monday.
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 announced two weeks ago, raising hopes that it could be available for public use by the end of the year.
Sources said that on Sunday evening, the subject expert committee of the Central Drugs Standards Control Organisation green-signalled the trial after evaluating it thoroughly.
As per the study design, each subject will be administered two doses of the vaccine 4 weeks apart (first dose on day 1 and the second dose on day 28) following which the safety and immunogenicity will be assessed at predefined intervals, sources said.
They added that the biotechnology firm has to submit safety data, evaluated by the Data Safety Monitoring Board to the regulator before it can proceed to phase-3 of the clinical trial.
Currently, phase 2, 3 clinical trials of the vaccine candidate developed by Oxford University is on in the United Kingdom and phase 3 clinical trial for the same vaccine candidate has started in Brazil. In South Africa, the vaccine is being assessed in phase 1 and 2 trials.
This particular vaccine candidate uses a common cold virus or adenovirus, 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—the pathogen that causes Covid-19.
The trial of the vaccine in India has been dubbed as especially significant as it is still unclear whether and how the different pre-existing immunity levels to the carrier adenovirus might impact the response to the vaccine.