Covaxin confirms that an ‘adverse event’ in phase I trials was reported to DGCI


“All treatment costs for the subject were paid in full by the sponsor, and that the subject is safe,” the company said in the statement, adding that it follows all safety guidelines as stipulated.

On November 16, Bharat Biotech began phase III testing of Covaxin. The phase III trials will involve 26,000 volunteers across India, the company said, adding that it is the largest clinical trial conducted for a COVID-19 vaccine in India.

Bharat Biotech had announced on June 29 that it had successfully developed Covaxin in collaboration with ICMR and NIV. The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The candidate vaccine has been developed and manufactured at Bharat Biotech’s high-containment facility located in Genome Valley, Hyderabad. Phase I trials began in July, while Phase II trials began in September.

(This article was originally published in The news minute and has been reissued in a deal with The Quint)

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