On July 27, the NIH said that United States scientists have begun a phase three trial of a potential COVID-19 vaccine, known as mRNA-1273, developed by Moderna.
The recommendations of the committee at the Central Drugs Standard Control Organisation (CDSCO) have been sent to the Drugs Controller General of India (DCGI) for approval, highly-placed sources told PTI. On Wednesday evening, SII submitted a revised protocol for conducting the trials to the DCGI.
"An urgent meeting was held by the subject expert committee on COVID-19 on Friday to consider SII's application".
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 DCGI on Tuesday had asked SII to clearly define Phase 2 and Phase 3 part of the protocol and resubmit their application for the evaluation by the committee. The panel also recommended that the proposed clinical trial sites be distributed across India, the source said.
A total of 79 volunteers have so far been successfully administered the first dose of indigenous Covid-19 vaccine, Covaxin, at Pt Bhagwat Dayal Sharma Post Graduate Institute of Medical Science here under the first phase of its human clinical trial. "It is envisaged that, once a vaccine has proven to be safe and effective against COVID-19, the Commission would have a contractual framework in place for the purchase of 300 million doses, on behalf of all European Union member states", the Commission said in a statement. To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.
A few days back Oxford University announced satisfactory progress with the vaccine making it a leading one among the dozens of vaccine candidates being developed around the world.