COVAXIN: Human Trials of India’s First COVID-19 Vaccine to Begin on 375 People Soon

Bharat Biotech is expected to begin human trials of its COVID-19 vaccine, COVAXIN, next week. COVAXIN, which is India’s first indigenous vaccine against the novel COVID19 and has been developed by Bharat Biotech in collaboration with Indian Council for Medical Research (ICMR) and NIV, Pune, will be tested on more than 1,100 people in phase 1 and 2 clinical trials.  

COVAXIN is derived from a strain of SARS-CoV-2 virus isolated in NIV, Pune, and transferred to Bharat Biotech to develop into a vaccine candidate. The company has set July 13 as the final date of enrollment for the trials. The company has planned to enrol 375 people in the first phase of clinical trials, an ICMR spokesperson told Bloomberg. The company said COVAXIN has demonstrated safety and immune response in preclinical studies. 

On July 2, ICMR Director chief Dr Balram Bhargava wrote to 12 trial sites for the indigenous vaccine, stating that all clinical trials need to be completed by August 15. However, the August 15 target was criticised by experts who said that fast-tracking vaccine trials in four weeks could pose serious health risks. In a statement on Monday, the Indian Academy of Sciences, a Bengaluru-based body of scientists, said that while it wishes the vaccine is quickly made available for public use, the announced timeline is únfeasible’ and unrealistic’. 

Meanwhile, Zydus Cadila’s plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, became the second Indian vaccine to receive regulatory approval for clinical trials. According to the company, the vaccine was found to be immunogenic in multiple animal species. Preclinical toxicity studies showed the vaccine to be well-tolerated, safe and immunogenic. 

Zydus announced that it has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects. The vaccine, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement.