Covaxin: Bharat Biotech's Covid vaccine candidate gets Phase 3 trials nod

Drugs Controller General of India (DCGI's) Expert Committee has given its nod to Phase III clinical trials of Bharat Biotech's Covid-19 vaccine Covaxin.

In a statement published on its website, the panel said it recommended granting the approval after studying the firm's Phase I and II data along with 'animal challenge data in two species'.

"After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct Phase III clinical trial," the statement reads. 

It, however, notes that the approval is 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

The Hyderabad-based vaccine maker had applied to the DCGI on October 2, seeking its permission to conduct Phase 3 trials for its Covid-19 vaccine candidate.