ICMR aims to launch indigenous COVID-19 vaccine by Aug 15

Henrietta Strickland
July 4, 2020

In the letter, ICMR Director General Dr. Balram Bhargava said they target to complete all clinical trials and launch the experimental vaccine for public use "latest by August 15, 2020". ICMR has fast-tracked the project and selected a dozen institutes for clinical trials of the indigenous COVID-19 vaccine (BBV152 COVID vaccine).

The first indigenous COVID-19 vaccine is being developed using a strain isolated at ICMR National Institute it Virology Pune.

While refusing to comment on the specific directions issued in Dr Bhargava's letter, former ICMR DG Dr Nirmal Kumar Ganguly said that each stage of clinical trial of a vaccine, if followed as per protocol, consumes months even after fast-tracking approvals.

The ICMR has selected 12 institutes, including one from Odisha, for the clinical trial of the country's first indigenous COVID-19 vaccine. However, the final outcome will depend on the corporation of all clinical trial sites involved in this project.

"You are advised to fast track all approvals needed for the initiation of clinical trials and ensure that subject enrolment is initiated not later than July 7", ICMR letter says.

The ICMR official said the aim was to complete all trials on the vaccine candidate by August 15.

A copy of the letter has been sent to the Bharat Biotech.

It further said no safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration.

The institutes have been asked by the ICMR to step up clinical trials as it is a "priority project" monitored at the topmost level of the government. It has now received permission from the Central Drugs Standard Control Organisation (CDSCO), headed by the DCGI, to initiate Phase I/II human clinical trials in India.

Mukti cited the limited production capabilities and capacities of biotech companies worldwide, and "challenges" to the global supply chain as reasons for the necessity of Indonesia developing its own vaccine. The company has now become the first company to manufacture a preservative-free vaccine (Revac-B mcf Hepatitis B Vaccine), launched India's first cell-cultured swine-flu vaccine, manufacture the world's cheapest Hepatitis vaccine and the first in the world to find a vaccine for the Zika virus.

Other reports by Click Lancashire

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