On 29 June 2020, Covaxin, India’s first Covid-19 vaccine candidate, received the go-ahead for human clinical trials from its drug regulator. The vaccine is developed from a strain of SARS-CoV-2 by Hyderabad-based Bharat Biotech (BBIL) in collaboration with the Indian Council of Medical Research (ICMR) — National Institute of Virology (NIV).
Bharat Biotech was granted permission by the Drug Controller General of India — CDSCO, Ministry of Health and Family Welfare to initiate Phase I and II human clinical trials after preclinical studies demonstrated safety and effective immune response. According to the company’s earlier press statement, human clinical trials are scheduled to start across India in July 2020.
In a letter dated 2 July 2020, ICMR wrote to Bharat Biotech that it is planning to fast track the human clinical trials of the Covaxin vaccine to launch it by 15 August. However, the vaccine’s safety and efficacy depend on the outcome of the fast track human clinical trials, which are yet to occur.
The letter states, “It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target; however, [the] final outcome will depend on the cooperation of all clinical trial sites involved in this project.”
Fast track human trials to begin on 7 July
According to reports, Bharat Biotech has declined comment on the matter. In contrast, the ICMR sources confirmed the letter’s authenticity by saying that it was meant for internal communication only. “This is the first indigenous vaccine being developed in India and is one of the top-priority projects which is being monitored at the top-most level of the government,” says the letter. It further states, “You have been chosen as a clinical trial site of the BBV152 COVID Vaccine. In 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 the initiation of the clinical trial and ensure that the subject enrollment is initiated no later than 7 July 2020.”
Prime Minister Narendra Modi chaired a high-level meeting on 30 June 2020 to review the planning and preparations for vaccination against Covid-19. On 3 July, the number of Covid-19 affected cases has crossed 6,00000, with over 18,000 deaths.