ICMR-Bharat Biotech to expedite clinical trials of Covid-19 vaccine, plan launch by August 15
First made-in-India vaccine against coronavirus disease (Covid-19) could be launched on Independence Day on August 15, according to a letter written by the Indian Council of Medical Research (ICMR) to institutions involved in developing the vaccine for the viral infection.
Dr. Balram Bhargava, director-general (D-G), ICMR, has written to the institutions that said: “This 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... it is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials.”
ICMR is working in collaboration with pandemic vaccine leader, Bharat Biotech, to develop this vaccine against Covid-19.
“We have asked Bharat Biotech to expedite the process,” said Rajnikant Srivastava, spokesperson, ICMR.
On Monday, Bharat Biotech got the approval from the Drugs Controller General of India to conduct human trials of the vaccine candidate, Covaxin, which it has developed.
The SARS-CoV-2 strain that causes Covid-19 was isolated in the ICMR-National Institute of Virology (NIV), Pune, and transferred to Bharat Biotech in May.
Coronavirus is a difficult virus to isolate.
However, scientists at NIV, Pune, had managed to isolate and culture 11 strains, which is the basic requirement to develop a vaccine in the future or any research related to the viruses.
Bhargava told the institutions that while the ICMR wanted the process to be expedited, the ultimate outcome would depend on the cooperation of the trial sites.
“...non-compliance will be viewed very seriously...,” he said in the letter.
There are about 13 trial sites identified and working on the project.
The indigenous, inactivated vaccine candidate was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level-3) high-containment facility located at Genome Valley in Hyderabad.
“The Drugs Controller General of India granted permission to initiate phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July,” Bharat Biotech said in a statement.
Bharat Biotech completed comprehensive pre-clinical studies within two months after receiving all necessary regulatory approvals from the ICMR.
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