PremiumDrugs Controller General of India (DCGI's) Subject Expert Committee (SEC) recommended granting of permission to conduct Phase III clinical trials 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.
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.
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
Over 25,000 people are expected to enrol for the trial and they will be given two doses of the experimental vaccine 28 days apart, according to reports. Preliminary results from the Covaxin trials have shown promising results.
Bharat Biotech is currently conducting Phase II human trials of Covaxin after receiving approval from the DCGI.
Earlier, the expert panel at Central Drugs Standard Control Organisation (CDSCO) had asked Bharat Biotech to submit safety and immunogenicity data from ongoing phase II trial in order to conduct phase III clinical trial of indigenous COVID-19 vaccine, Covaxin.
According to the Subject Expert Committee (SEC) meeting, the firm presented the phase III clinical trial protocol along with interim data of phase I and II clinical trials on October 2.
In July, the DCGI had granted permission to pharma company Bharat Biotech to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19.
In this regard, Bharat Biotech has partnered with Indian Council of Medical Research (ICMR) to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR's National Institute of Virology, Pune.
The central government expects that a COVID-19 vaccine will be ready for sale in India as early as December if clinical trials are successful, according to a Mint report.
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