Bharat Biotech-ICMR developed Covaxin is safe, show prelimin
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Preliminary results of phase 1 clinical trials of the Bharat Biotech-ICMR developed Covid-19 vaccine, Covaxin, suggest that the vaccine is safe, principal investigators conducting the trials told ET.

The vaccine is being tested on 375 volunteers who have enrolled at 12 sites in India. Two doses of the vaccine are being administered to each volunteer.

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

While volunteers are being administered with the second dose, investigators are collecting blood samples which will test the immunogenicity of the vaccine.

Once the safety data from all 12 sites shows desirable results, the company will approach the Drug Controller General of India for conducting Phase II trials. “If all goes well, the vaccine may be available in the first half of next year,” said another investigator, on the condition of anonymity.

Source: https://health.economictimes.indiatimes.com/news/pharma/bharat-biotech-icmr-developed-covaxin-is-safe-show-preliminary-phase-i-results/77533480
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