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New Delhi, Jul 3: In a significant step, ICMR has partnered with Bharat Biotech International Limited (BBIL) to fast-track clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID Vaccine). It is the first indigenous vaccine being developed by India and is one of the top priority projects which is being monitored at the topmost level of the Government, says ICMR in a statement.

The vaccine is derived from a strain of SARS-CoV-z isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine.

In a letter to the institutes that will be involved in the trails of the vaccine, ICMR has said

"It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target. However, final outcome will depend on the cooperation of all clinical trial sites involved in this project. you have been chosen as a clinical trial site of the BBV152 COVID vaccine. ln view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated no later than 7th July 2020."

The ICMR also asked the institutes to comply with the order, "Kindly note that non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on the highest priority and meet the given timelines without any lapse."

The ICMR has selected 12 institutes, including one from Odisha, for the clinical trial of the country's first indigenous COVID-19 vaccine.

New Delhi, Jun 4: CSIR Director-General Shekhar Mande said on Thursday that the World Health Organisation's (WHO) decision to halt hydroxychloroquine (HCQ) drug trial was taken in haste and the global body should have actually analysed the data before making the decision.

"I firmly believe that WHO decision was taken in haste it was a kind of knee jerk reaction they should have actually analyse the data on their own before temporarily suspend the trials that is my personal opinion," Mande said.

India's nodal government agency ICMR (Indian Council of Medical Research) overseeing the country's response to the coronavirus pandemic last month wrote to the WHO citing differences in dosage standards between Indian and international trials that could explain the efficacy issues of HCQ in treating COVID-19 patients.

In addition, Dr Sheela Godbole, National Coordinator of the WHO-India Solidarity Trial and Head of the Division of Epidemiology, ICMR-National AIDS Research Institute also wrote a letter via an email to Dr Soumya Swaminathan, Chief Scientist at World Health Organisation.

In a letter, Dr Godbole stated: "There was no reason to suspend the trial for safety concern," attributing it to the current RECOVERY data which differs significantly from the non-randomised assessment by Mehra et al, a scientific paper.

Referring to the letter, the CSIR head said, "We don't know what actually happened behind the scenes but the hypothesis is that because of the paper published in Lancet. It is a very well known journal and if Lancet has done due vigilance in publishing the paper. 

Therefore, the WHO thought the paper's findings are right that's why WHO hold based on what is published on Lancet. The WHO shouldn't have accepted it immediately this should have taken their own due vigilance to find out that study is right or not."

DG CSIR said because there is a global outcry it must have put pressure on both Lancet as well as WHO and both of them now retracted from their original position. "WHO has started a trial again and Lancet has put an expression of concern on their website both of these are very welcome development for science," he said.

"So I am pretty sure that Lancet would have published the reports only after seeing somewhere the drug failed to work," Mande said.