Bharat Biotech gets DCGI nod to conduct phase 3 trial of Covaxin
A subject expert committee on Covid19 at the CDSCO had recommended granting permission to the Bharat Biotech for conducting phase 3 clinical trial of its vaccine 'Covaxin' after assessing the safety and immunogenicity data of phase 1 and 2 trials.;
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New Delhi: The Drugs Controller General of India (DCGI) on Friday permitted Bharat Biotech to conduct phase 3 clinical trials of its indigenously developed Covid-19 vaccine with certain conditions, officials said.
A subject expert committee on Covid-19 at the Central Drugs Standard Control Organisation (CDSCO) had recommended granting permission to the Hyderabad-based firm for conducting phase 3 clinical trial of its vaccine 'Covaxin' after assessing the safety and immunogenicity data of phase 1 and 2 trials.
"The DCGI gave permission to Bharat Biotech to conduct phase 3 clinical trial of the 'Covaxin' on Friday," an official told PTI.
The vaccine 'Covaxin' is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The vaccine maker had applied to the DCGI on October 2 seeking permission to conduct phase 3 randomized double-blind placebo-controlled multicentre trial of its Covid-19 vaccine.
Once a suspect case is confirmed the principal investigator will evaluate the clinical information to classify it as a symptomatic case.
"Two criteria must be met for a participant to be a confirmed symptomatic case. Either criteria A or B with positive RT-PCR confirmation," the recommendations stated.
Criteria A includes shortness of breath/difficulty in breathing, new-onset anosmia/aguesia, oxygen saturation of <94 percent or escalation in supplemental O2, pneumonia diagnosed by chest X-ray or CT scan, evidence of shock, ICU admission/death (one or more).
Criteria B includes fever, chills, new cough, myalgia/fatigue, headache, sore throat, nausea/vomiting, diarrhea, congestion/runny nose (one or more symptoms).
In July, the Drug Controller General of India (DCGI) had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its Covid-19 vaccine.
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