The expert panel at Central Drugs Standard Control Organisation (CDSCO) has recommended the top drug regulator to grant permission to Bharat Biotech to conduct phase III clinical trial using the indigenous covid19 vaccine–Covaxin, with subject to the condition.
“In continuation of the Subject Expert Committee (SEC) meeting dated 5 Oct, the firm presented their data from a 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,” according to a government official.
“After detailed deliberation and based on the available evidence, 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–(i) once a suspect case is confirmed the principal investigator (PI) will evaluate the clinical information to classify it as asymptomatic case,” the SEC noted on 118h meeting held on Tuesday.
“Two criteria must be met for a participant to be a confirmed symptomatic case. It is either criteria A or B with positive RT-PCR confirmation,” said recommendation of SEC.
“In Criteria A, it includes that one or more – shortness of breath/difficulty in breathing, new-onset anosmia/aguesia, oxygen saturation of <94% of escalation in supplemental 02, pneumonia diagnosed by chest X-ray or CT scan, evidence of shock, ICU admission/death. Or, in criteria B–two or more – fever, chills, new cough, myalgia/fatigue, headache, sore throat, nausea/vomiting, diarrhea, congestion/runny nose,” SEC deliberated adding that the events not meeting the primary endpoint shall be categorized as secondary endpoints.
Recently, drug maker–Bharat Biotech submitted safety and immunogenicity data from an ongoing phase II trial to DCGI in order to conduct a phase III clinical trial for Covaxin. However, during the evaluation, the expert committee asked the pharma company to submit safety and immunogenicity data from the phase II clinical trial for consideration. In the previous SEC meeting, it opined that they require clarification on the definition of asymptomatic.
In July, the Drug Controller General of India (DCGI) had granted permission to Bharat Biotech pharma giant to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19.
For this, Bharat Biotech has partnered with the Indian Council of Medical Research (ICMR) country made COVID-19 vaccine using the virus strain isolated by ICMR’s National Institute of Virology (NIV) based in Pune.