The Drugs Controller General of India on Friday permitted Bharat Biotech to conduct phase 3 clinical trials of its indigenously developed COVID-19 vaccine with certain conditions, officials said.
A subject expert committee on COVID-19 at the Central Drugs Standard Control Organisation had recommended granting permission to the Hyderabad-based firm for conducting phase 3 clinical trial of its vaccine 'Covaxin' after assessing the safety and immunogenicity data of the phase 1 and 2 trials.
"The DCGI gave permission to Bharat Biotech to conduct phase 3 clinical trial of the 'Covaxin' on Friday," an official told PTI.
The vaccine 'Covaxin' is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research.
The vaccine maker had applied to the DCGI on October 2 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.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
The phase 3 clinical trial application proposed a dose of 0.5 ml on day 0 and 28, sources said.
In continuation of the subject expert meeting held on October 5, the Hyderabad-based firm presented its data from phase 1 and 2 along with animal challenge data in two species, including non-human primates, 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 based on the available evidence, the 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...," the recommendations said.
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).
In July, the Drug Controller General of India had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.