Central Drugs Standards Control Organisation has deferred its decision on Serum Institute of India's proposal for trials of coronavirus vaccine candidate developed by University of Oxford and AstraZenca. Country's apex drug regulator has asked the company to amend its protocol for Phase II and III clinical trials of the COVID-19 vaccine.
Adar Poonawalla's Serum Institute had filed an application last week, seeking permission from Drugs Controller General of India for trials of Oxford-AstraZenca vaccine candidate, Covishield. The company had said that around 1,600 participants of more than 18 years would be enrolled in the clinical trials.
In it's meeting on Tuesday, the subject expert committee (SEC) for COVID-19 related proposals in Central Drugs Standards Control Organisation (CDDSCO) asked Serum Institute to submit revised protocol for evaluation. The regulator has asked Serum Institute to demarcate Phase II and Phase III parts of the protocol and conduct Covishield trials all over India, the daily further reported.
Covishield has been jointly developed by Jenner Institute of Oxford University and British-Swedish pharma company AstraZeneca. It has shown promising results in tests so far. A Lancet report claimed that the initial trial results demonstrated that the innoculation is safe and prompts protective immune response. Oxford University on Monday announced satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world.
Serum Institute has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it gets ready. The company has promised to produce and supply 1 billion doses of the COVID-19 vaccine.
Last Monday, NITI Aayog member Dr V K Paul had said that India will ensure regulatory facilitation and actively consider supplementing resources if needed for expediting SII's phase 3 trial of the vaccine developed by Oxford University.