India's leading biotechnology company Bharat Biotech expects to launch Covaxin, its indigenously developed coronavirus vaccine, by June 2021. The Hyderabad-based firm on Friday received approval from the Drugs Controller General of India (DCGI) to conduct phase 3 clinical trials of its vaccine with certain conditions.
"If we get all the approvals in place, I think during Q2 of 2021, we should get the efficacy readout from our phase-3 clinical trial -- April, May, June, for example. That is for the full efficacy results," Sai Prasad, executive director, Bharat Biotech International Ltd, told the Indian Express.
"We are committed to doing all our phase-1, phase-2 and phase-3 clinical trials in its entirety, but I think the government may also be considering emergency use approval," Prasad said. The top official, however, said that the firm is not pushing for such an approval. "Our intent is to develop everything to its logical conclusion in terms of empirical evidence and data, and efficacy data and safety data. But there are discussions, I guess, within the government about that (emergency use approval)," he said.
Developed in collaboration with the Indian Council of Medical Research (ICMR), the vaccine's phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above. It will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow. According to PTI sources, the phase 3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28.
Earlier on October 2, the vaccine maker had applied to the DCGI seeking permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine. It was asked to submit complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage.
PHASE-3 and the criterion
Bharat Biotech presented its 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. After detailed deliberation and based on the available evidence, a subject expert committee recommended for grant of permission to conduct phase 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 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).