Health Ministry issues clarification on indigenous Covid-19 vaccine, assures safety will not be compromised

Union Ministry of Health and Family Welfare on Thursday issued a clarification on August 15 deadline for Covaxin, assured fast-track clinical trials will not compromise safety and security concerns.

The Union Health Ministry on Thursday clarified that 15 August deadline for an indigenous Covid-19 vaccine is “only to expedite duly approved clinical trials without compromising on safety and security concerns”.

During the press conference, Rajesh Bhushan, Officer on Special Duty, Health Ministry said, “Please don’t read something which is not there in DG-ICMR’s letter. Letter’s intent is only to expedite duly approved clinical trials without compromising on safety and security concerns.”
Earlier, ICMR DG Balram Bhargava wrote a letter to Bharat Biotech and principal investigators of medical colleges to complete the trial procedure of indigenous COVID-19 vaccine in a fast track method so that results of a clinical trial can be launched by August 15.

Bhushan further said that DCGI has permitted two vaccines to go in for phase 1 and 2 of clinical trials.

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“Bharat Biotech and Cadila Healthcare are developing vaccines. Both vaccines completed animal toxicity studies after approval. DCGI has permitted these two vaccines to go in for phase 1 and 2 clinical trials. Trials are yet to begin. Hope it begins soon.

Bharat Biotech had recently received a nod for a clinical trial of its vaccine – Covaxin.

A total of 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine as it is being considered the topmost priority projects which are being monitored by the government.

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