Following an adverse event during the phase I clinical trial which was immediately reported to the CDSCO-DCGI, Bharat Biotech has finally entered the phase III human clinical trial of Covaxin (Indian Coronavirus Vaccine). The trial has begun recently at AIIMS with Dr M.V Padma Srivastava, chief of Neurosciences Centre, AIIMS and three other volunteers being the first people to receive the first dose. Bharat Biotech has acquired the permission for conducting phase III human clinical trials from the Drugs Controller General of India.
Over the next few days, the dose will be further given to around 15,000 volunteers at AIIMS. Report has it that four volunteers who were given the first dose of 0.5 ml intramuscular injection, were kept under observation for two hours and will be monitored continuously for the next few days.
While applying for phase III trial, the Hyderabad-based firm stated that the Covaxin was well-tolerated during its phase I and II trials the data of which has been submitted to the central drug regulator. While no serious side-effect has been observed, one of the most common adverse event was pain on the injection site which was later resolved.
Covaxin is being collaboratively developed by Bharat Biotech and Indian Council of Medical Research (ICMR). Besides this, four other coronavirus vaccines are currently under different trial phases in India. Serum Institute of India is conducting phase III trial of the Oxford-Astrazeneca Coronavirus Vaccine while Cadila Healthcare has recently completed the phase II clinical trial of Zydus Cadila in the country.
Similarly, Dr Reddy’s Laboratories is said to be commencing its combined phase II and III clinical trials of Sputnik V – a Russian coronavirus vaccine, in India and Biological E. Ltd has already started its early phase I and II human trials of its coronavirus vaccine.