Sunday, August 9, 2020

ICMR sets Aug 15 deadline for Covid Vaccine - AIIMS says Phase-I trials not over yet

“Covaxin initial results encouraging”, Dr Sanjay Rai AIIMS Principal Vaccine Investigator

Harish Gupta, National Editor, Lokmat Group

New Delhi, Aug. 9

PM Narendra Modi may have cut short bureaucratic delays to fast-track Coronavirus Vaccine trials in India. But the wonder drug will continue to elude as trials and may take longer than the August 15 deadline set by Indian Council of Medical Research.

It is authoritatively learnt that the Bharat Biotech’s Covaxin vaccine trials that began at the prestigious AIIMS and 11 other facilities across India last month, has not even completed Phase-I stage. The ICMR has partnered with the Hyderabad based Bharat Biotech to invent and manufacture vaccine.

Zydus Cadila’s ZyCov-D has was also been given permission for phase-I & II human clinical trials at its own facilities.

The ICMR raised the hopes when its director Dr Balram Bhargawa told reporters last week that phase-I and Phase-II trials for Covaxin drug would be completed before August 15.

But Dr Randeep Guleria, Director, AIIMS clarified, “We are rushing trials for the vaccine and clubbed phase-I & II trials. The human clinical trials will follow all safety norms.”

When contacted, Dr Sanjay Rai, Principal Investigator, AIIMS who is coordinating the Bharat Biotech’s Covaxin trials, told Lokmat this morning, “We have completed the Phase-I trials results which are very encouraging. There was no reaction to the drug. We gave single dose to Vaccine warriors and now double dose will be given to them to test its efficacy.”

In reply to a question, Dr Rai said phase-II trials will begin only after results of double dose are out in the next 10-15 days.

When asked why reports have been surfacing that the wonder drug will be out shortly, Dr Sanjay Rai said, “The government clubbed the phase-I & II clearances only. This was to cut delays and not aimed at compromising safety norms.”

Currently, trials of three vaccines including the one produced by the Oxford University & Seerum Institute, Pune are under way. Experts say that no Covid vaccine is likely to make it before the year-end.