Indian COVID-19 vaccine update: Bharat Biotech’s Covaxin gets nod for phase 3 trials
New Delhi: COVAXIN, India’s first indigenous vaccine against the novel coronavirus (SARS-CoV-2), has been cleared for the late-stage, phase 3 clinical trials even as scientists all over the world race against time to find an effective jab against COVID-19. The vaccine is being developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
According to reports, citing official sources, the recommendation was given by an expert panel at the Central Drugs Standard Control Organisation (CDSCO) after assessing the safety and immunogenicity data of phase 1 and 2 clinical trials and have been sent to the Drugs Controller General of India (DCGI) for final approval.
“The DCGI is likely to give its final nod by tonight or tomorrow,” they said.
On October 2, Bharat Biotech had sought the DCGI’s permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate. However, the vaccine maker was asked to submit the complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage, reported PTI.
According to the company, the study would enroll about 28,500 volunteers aged 18 years and above and would be conducted in 19 sites across 10 states, including Delhi, Mumbai, Patna and Lucknow. Sources also revealed that the phase 3 clinical trial application has proposed a dose of 0.5 ml on day 0 and 28.
In continuation of the subject expert meeting held on October 5, the Hyderabad based firm presented their data from phase 1 and 2 along with animal challenge data in two species including non-human primates (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, the recommendations stated.
“After detailed deliberation and the available evidences, the committee recommended that permission to conduct phase 3 clinical trial be granted subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended as below…,” the panel said.
The report added that once a suspect case is confirmed, the principal investigator 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,” the recommendations stated.
Criteria A includes – 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 (one or more). Criteria B includes – fever, chills, new cough, myalgia/fatigue, headache, sore throat, nausea/vomiting, diarrhea, congestion/runny nose (one or more symptoms).
The DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of COVAXIN. Besides COVAXIN, another indigenously developed vaccine candidate developed Zydus Cadila is also in phase 2 of human clinical trials. Also, the Serum Institute of India (SII) is conducting the phase 2/3 clinical trials of Oxford-AstraZeneca’s COVID-19 vaccine candidate, in the country.