It is the stuff movies are made of – big pharma going into the slums of India to conduct vaccine trials on the most vulnerable and marginalised of society, sometimes with tragic consequences.
With lockdown restrictions in place for much of last year, areas in North Bhopal are struggling with high unemployment, and many people were attracted by the payment accompanying the vaccine, and signed forms that they couldn’t read given that many are illiterate. One of the participants of the third phase trial, Deepak Maravi, died nine days after receiving the vaccine, and several others experienced several illnesses.Bharat Biotech says his death was not related to the vaccine, but gave no bioethical basis for that.
The approval lacked efficacy data which is usually arrived at once Phase 3 trials have been concluded. The vaccine trial involves two shots that are supposed to be administered 27 days apart. After the two shots, participants are supposed to be tracked and tested until enough have contracted Covid-19 to allow the vaccine’s efficacy to be analysed. By December 22, Covaxin admitted it had recruited only 13 000 participants – half of its target for the Phase 3 trial.
India’s National Institute of Immunology and the Coalition for Epidemic Preparedness objected to the defiance of the CDSCO guidelines, which requires a minimum efficacy of 50% in Phase 3 trials. Vineeta Bal, an immunologist at the National Institute of Immunology described the approval of a vaccine without phase 3 data as “unconscionable” and said it would hurt public trust and risk frontline lives.
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