Bharat Biotech, in collaboration with apex research body Indian Council of Medical Research (ICMR), has developed Covaxin, an inactivated virus vaccine, for which it commenced Phase III clinical trials on November 16, involving around 26,000 participants. The adverse event did not lead to any life-threatening reaction, and hence, was categorised as “not severe and related to the vaccine”, they added.
The participant, undergoing the trial at a western India site, was hospitalised with viral pneumonitis, a couple of days after being administered the vaccine. He was discharged after a week.
When contacted, a spokesperson from Bharat Biotech said: “We have reported the adverse event to the DCGI office.” The company did not respond to the questionnaire despite repeated attempts.
The findings have been reported to the Ethics committee, and Central Drugs Standard Control Organisation (CDSCO), and were also taken up by the Subject Expert Group, a government panel on Covid-19, sources said.
Side-effects or adverse events are routine in large-scale trials, and globally, MNCs AstraZeneca and Johnson & Johnson had paused their vaccine trials due to serious adverse events, only to re-start them after a thorough investigation.
Experts say there is lack of transparency when it comes to vaccine clinical trials in India. As against this, globally, pharma biggies including Pfizer and Moderna have announced detailed data. Recently, the US Food and Drug Administration said it is fully committed to transparency regarding emergency approvals around Covid-19 drugs and vaccines, and will publicly disclose the review of scientific data.
“Transparency is key to building trust and public confidence in Covid-19 vaccines that may receive approval. Given the extensive and continuing role of the government in developing this vaccine, the agreement between ICMR & Bharat Biotech should be made public. We do not know whether the government is retaining rights or the terms for commercialisation,” said Malini Aisola, co-convenor of All India Drug Action Network, a civil society organisation working for patients’ rights.
The ‘indigenous’ Covid-19 vaccine has courted several controversies from the start, with questions raised initially about unduly fast tracking the regulatory process, role of the government and ICMR’s conflict of interest in its development.