India's first indigenous coronavirus vaccine, Covaxin, is safe and built on a time-proven technology, claimed Bharat Biotech's chairman and managing director Krishna Illa.
Bharat Biotech, which is conducting a Phase-3 clinical trial of Covaxin in over 25 centres across India, applied to the drug regulator seeking emergency authorisation for its COVID-19 vaccine last week based on Phase 1 and 2 trial data.
Covaxin has been developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
Speaking virtually at a programme organised by the industry body FICCI, Ella said: "Data from monkeys have shown the efficacy and the Phase 1 and 2 human trial data showed that it was safe, one could apply for marketing approval".
He added the company has sought emergency approval of the vaccine as it is safe and can be given to any age group of people.
According to Ella, "It's not that without any evidence we are jumping on. There's nothing wrong with this. Phase-2 also we have done on 2,000 people which is not a small number. We have multiple evidence, we are not jumping on something which is a new technology."
Ella's statement came after an expert committee of the Central Drugs Standard Control Organisation (CDSCO) sought additional safety and efficacy data for COVID-19 vaccine candidates of Bharat Biotech after deliberating upon its applications seeking emergency use authorisation for the shots.
"After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration," the SEC stated. Bharat Biotech began its phase 3 trials on November 17. So far, the firm has recruited 8,000 participants for the Phase-3 clinical trial.