Covaxin: Bharat Biotech gets nod from DCGI panel for Phase III trials

The nod is subject to amendment in how primary efficacy endpoint for symptomatic cases be studied in Phase 3 trials, the panel further stated.

Drugs Controller General of India (DCGI’s) Expert Committee recommended granting permission to conduct Phase III clinical trial for Bharat Biotech’s Covid-19 vaccine Covaxin.

The panel added that the recommendation is after assessing data from Phase I & II as well as animal challenge study.(HT file photo)

The panel added that the recommendation is after assessing data from Phase I & II as well as animal challenge study.

The nod is subject to amendment in how primary efficacy endpoint for symptomatic cases be studied in Phase 3 trials, the panel further stated.

“In continuation of the SEC meeting dated 05.10.2020, firm presented their data from Phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event driven Phase III clinical trial to assess the efficacy of the vaccine,” the expert panel said in a statement on Tuesday.

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The committee recommended for grant of permission to conduct Phase III clinical trial subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended as below:

-Once a suspect case is confirmed the PI 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.

Criteria A: One or more - Shortness of Breath/Difficulty in breathing, New onset Anosmia/Aguesia, Oxygen saturation of <94% or escalation in supplemental O2, Pneumonia diagnosed by chest X ray or CT scan, Evidence of Shock, ICU Admission/Death OR

Criteria B: Two or more - Fever, Chills, New cough, Myalgia/Fatigue, Headache, Sore throat, Nausea/Vomiting, Diarrhea, Congestion/ Runny Nose