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Covaxin efficacy can be determined after second dose: Bharat Biotech issues statement after Vij tests positive

Earlier on November 20, Anil Vij had been administered one shot of Bharat Biotech's Covaxin as part of its clinical trials.

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Hours after Haryana Health Minister Anil Vij tweeted about him been tested coronavirus positive, Hyderabad-based Bharat Biotech whose vaccine clinical trials the minister was part of, has said that the efficacy of its vaccine, could be determined only 14 days after a second dose.

Earlier on November 20, Anil Vij had been administered one shot of Bharat Biotech's Covaxin as part of its clinical trials. He was administered the trial dose of Covaxin at the same Ambala cantt civil hospital, where he is presently admitted.

Bharat Biotech said that its clinical trials were based on a two-dose schedule, given 28 days apart.

"Covaxin clinical trials are based on a two-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the second dose. Covaxin has been designed to be efficacious when subjects receive both doses," the biotechnology company said in statement, reported news agency ANI.

According to the company, as part of the trial 50 per cent of the participants received the vaccine while the others were administered a placebo.

"The phase-3 trials are double-blinded and randomised, where 50 per cent of subjects (participants in the trial) receive vaccine and 50 per cent of subjects receive a placebo," it said.

Vij had offered to be the first volunteer in the phase three human trials for the potential coronavirus vaccine Covaxin in which over 25,000 persons were administered trial doses. 

On November 20, Vij was the first in Haryana to be administerd the shot. Besides him, over 400 persons from Haryana, including Rohtak PGIMS' Vice Chancellor Dr OP Kalra, participated in the trials.

A team of Rohtak Post Graduate Institute of Medical Sciences had administered the vaccine to Vij at Ambala Cantonment’s civil hospital. His health and vitals were being monitored on a weekly basis ever since.

Bharat Biotech is developing the vaccine in collaboration with the National Institute of Virology (NIV) and the Indian Council of Medical Research (ICMR). It is among the several indigenous vaccines being developed in the country.

India recorded 36,652 new COVID-19 cases in the past 24 hours. The overall COVID-19 cases reached 96,08,211, including 4,09,689 active cases and 90,58,822 recoveries.

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