Did Bharat Biotech Follow Covaxin Clinical Protocols in Bhopal?

The COVID-19 vaccine is jointly made by Bharat Biotech and the Indian Council of Medical Research.

Why are there fears of ethical breaches in the clinical trial and what does it mean for Bharat Biotech’s Covaxin?

(Photo: The Quint)

On Sunday, 3 January, Covaxin became India's first indigenously produced vaccine against the novel coronavirus to get 'emergency approval in public health interest in clinical trial mode.’

The vaccine is jointly made by Bharat Biotech, Indian Council of Medical Research and National Institute of Virology.

However, its approval raised many questions, especially since phase 3 clinical trials were still ongoing and no efficacy data had been published.

Several media outlets in January 2021 reported on the vaccine’s clinical trial at People’s Hospital Bhopal, one of the several sites were phase 3 trials are taking place.

The reports pointed to how poor people were lured without any understanding that they were taking part in a vaccine trial and not a vaccination drive.

There has been one death and several participants have reported illnesses at this site.

Why are there fears of ethical breaches in the clinical trial and what does it mean for Bharat Biotech’s Covaxin?