Covaxin phase-III: Bharat Biotech denies cover-up of trial volunteer’s illness

The trial of India’s indigenous COVID-19 vaccine, Covaxin, took a beating after a ‘trial volunteer’ took seriously ill after taking a test dose. The allegation is that Bharat Biotech, the Hyderabad-based company which is running the trial and developing the vaccine, had not stopped the trial after the mishap.

The 35-year-old trial volunteer had taken the vaccine in the first stage of the trial in August and contracted pneumonia. He was discharged after a week and had no history of illness.

As per guidelines, the trial should be temporarily halted if any issue is reported. Other companies had adhered to this protocol. However, in this case, neither the company nor the Central Drugs Standards Control Organisation (CDSCO) reported the matter.

The phase-III trials of Covaxin had started on November 16 after the initial two stages were deemed successful. The phase-III trial are being held in 22 partnering hospitals and 26,000 people have enlisted a volunteers.

Bharat Biotech clarified that the ‘issue’ was reported to the CDSCO. The company said it was found in investigations that the vaccine had no problem. Bharat Biotech said any medicine would have some side effects. The volunteer here was safe, it added.