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Bharat Biotech-ICMR developed Covaxin is safe, show preliminary phase I results

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NEW DELHI: 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.

“As of now we know that it is safe. The second step is to know how effective the vaccine is for which we have started collecting the samples,” added Verma. The investigators are expecting to finish the Phase I by August end.

“We are in the process of giving a second dose to the healthy volunteers and so far, we have not seen anything unusual event in patients.

It is safe,” said Sanjay Rai, principal investigator at All India Institute of Medical Sciences, Delhi. AIIMS had recruited 16 volunteers for testing the Bharat Biotech vaccine.

As the race to secure vaccines begins, the government is keeping a close eye on developments. Covaxin is India’s first vaccine candidate and is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). The vaccine is developed from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.

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.

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