COVID-19 Vaccine in India Update: Serum Institute to Start Phase 3 Trials of Oxford Candidate After Clearances, Says ICMR

New Delhi, September 15: The Serum Institute of India (SII) would begin the third phase of trials after receiving clearances from the Drugs Controller General of India (DCGI), said the Indian Council of Medical Research (ICMR) on Tuesday. The statement was made as part of the weekly updates being issued by the Union Health Ministry over the vaccines being developed by India. Sputnik V Vaccine Update: Over 300 Volunteers Get Russian COVID-19 Vaccine, 14% Have Minor Complaints.

"Three vaccines at clinical trial stage in India. Cadila and Bharat Biotech have completed phase-I trials. Serum Institute has completed phase II-B3 trials, and will start phase-III trial (with 1500 patients at 14 locations) after clearances," Prof Balram Bhargava, DG, ICMR said.

Serum Institute, which by scale of operations is the world's largest manufacturer of vaccines, has partnered with with Oxford University and drugmaker Astrazeneca for the production of their vaccine candidate.

The late second stage trials have been completed and the third round of clinical tests were halted after a volunteer in the UK developed fever. Serum chief executive officer Adar Poonawalla, while speaking to a leading daily, said he is hopeful of the trials to resume in India at the earliest. On the volunteer falling ill in the UK trials, he said it was a "very normal issue".

The trials in the UK were resumed in the past week by Oxford-Astrazeneca. The Indian regulator is also expected to give the nod for resumption of tests in the near future. Serum Institute, as per the partnership with Oxford, will produce 1 billion doses of the vaccine -- half of which it has pledged for usage in India.

(The above story first appeared on LatestLY on Sep 15, 2020 05:49 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).