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NEW DELHI: Bharat Biotech International Ltd had an adverse event during the phase 1 trial in August, when a patient was hospitalized after receiving a dose of the covid-19 Covaxin vaccine. But the matter was not made public by either the company or the regulator, the Central Medicines Standards Control Organization and its chief of General Medicines Control of India, VG Somani.
“The adverse event during the phase I clinical trials during August 2020 was reported to the CDSCO-DCGI within 24 hours of its occurrence and confirmation. The adverse event was thoroughly investigated and determined not to be related to the vaccine, “the company said in a statement.
Unlike Bharat Biotech, AstraZeneca and Johnson & Johnson had temporarily stopped their phase 3 clinical trial immediately after an adverse event was observed in one patient, each after receiving their respective vaccines.
The Bharat Biotech issue came to light on Saturday when The Times of India and The Economic Times reported the story.
According to The Times of India report, the adverse event occurred in a 35-year-old participant with no comorbidities, who was part of phase 1 trials at a site in western India. The participant was hospitalized with viral pneumonitis a couple of days after receiving the vaccine. He was discharged after a week of hospital stay.
“The sponsor paid the subject’s treatment costs in full and the subject is safe,” Bharat Biotech said.
Bharat Biotech is conducting three-stage clinical trials of Covaxin, a new, fully inactivated coronavirus vaccine, in collaboration with the lead biological research agency, the Indian Council for Medical Research.
Bharat Biotech said it submitted all documentation on time and as mandated by the ethics committees and CDSCO, including a full causation report.
The company says it obtained approval for the next two phases of clinical trials only after a detailed investigation of the incident was completed.
Bharat Biotech earlier this week began its third and final stage of the clinical trial at the Nizam Institute of Medical Sciences in Hyderabad. The company plans to enroll up to 26,000 participants in the massive phase 3 trial, the largest efficacy trial ever conducted in India, and it is expected to cost the company approximately ₹150 crore.
Mint is awaiting responses to inquiries sent to the company and Somani, especially on how to make its detailed phase 3 protocol public and report adverse events in the final stage of the study.
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