The Indian Council of Medical Research on Thursday said that it aims to launch the Coronavirus vaccine being developed in partnership with Hyderabad-based Bharat Biotech for public health use by August 15. This is as per a letter written as internal communication by ICMR to Bharat Biotech asking for fast-tracking of the indigenous vaccine with an aim to launch it by August 15.
“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,” the letter says. ICMR sources confirm authenticity of the letter but say it was meant for internal communication.
The indigenous vaccine being developed in India is one of the top-priority projects which is being monitored at the top-most level of the government, the statement further read. PM Modi had recently held a high-level meeting to take stock on the indigenous vaccine efforts.
Meanwhile, the Drug Controller General of India has approved pharmaceutical firm Zydus Cadila to start Phase I and Phase II human clinical trials of its COVID-19 vaccine. This is the second vaccine after Hyderabad-based Bharat Biotech’s COVAXIN to get the approval. The approval process was fast-tracked following recommendation by the subject expert committee on COVID-19, considering the emergency and unmet medical need during the pandemic. The assent for human trials was given after the company submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to safety and immunogenicity, sources said. The company is likely to start enrolment of subjects soon. “The phase I and II trials will take around three months to be completed,” the source said.