Phase-II Trial Of Bharat Biotech’s Covaxin To Begin In September

New Delhi: Covaxin, the indigenously developed COVID-19 vaccine, has been found to be safe, according to preliminary results of Phase-I clinical trials.

Covaxin is developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology (NIV).

“The vaccine is safe. We have not observed any adverse events in any of the volunteers at our site,” said Savita Verma, the principal investigator who is leading the trial at PGI, Rohtak, was quoted as saying by the Economic Times.

Investigators are collecting blood samples to test the immunogenicity of the vaccine and expect to complete the Phase 1 trials by the end of August.

As many as 375 volunteers at 12 sites except for AIIMS Delhi-where Phase-I trial is still underway, across India have enrolled for the clinical trial, with two doses being administered to each individual.

However, many centres are bracing for the recruitment of candidates for Phase-II human trials, which are scheduled to begin in the first week of September.

Meanwhile, the Serum Institute of India (SII) that has been granted regulatory approval to conduct Phase-II and III trials in India of Covishield, a vaccine created by University of Oxford and AstraZeneca. SII plans to start human trials in less than two weeks, reported India Today.

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