Leading vaccine maker Bharat Biotech, which is developing India's own vaccine for coronavirus named COVAXIN has got the nod from the Drugs Controller General of India (DCGI) to conduct phase 3 clinical trials. The development has come after Bharat Biotech Ltd, a Hyderabad based company presented its data from Phase 1 and 2 along with animal challenge data in two species including NHP on the Inactivated Coronavirus Vaccine (BBV152) along with the proposal to conduct event driven Phase 3 clinical trial to assess the efficacy of the vaccine in the SEC meeting to examine COVID-19 related proposals under accelerated approval process made in its 118th meeting at CDSCO, Headquarters, New Delhi.
After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct Phase III (3) 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 per cent 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 events not meeting the primary endpoint shall be categorized as secondary endpoints.
Covaxin is the first indigenous vaccine developed by India against COVID-19 and is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.
ICMR and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine.
According to Bharat Biotech, this intranasal vaccine candidate has already shown unprecedented levels of protection in mice studies; the technology and data having been recently published in the prestigious scientific journal ‘Cell' and in an editorial in ‘Nature'.
This vaccine expands Bharat's portfolio of vaccines that are currently being developed and are in various stages of clinical development including Covaxin which is currently in Phase II human clinical trials in India, the company said.