New Delhi: Covaxin, an indigenously developed vaccine candidate by Bharat Biotech, has received clearance for phase 3 trial in India. The trials will start in the first week of November, sources said.
The vaccine is being developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on October 2, seeking its permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine candidate.
The firm in its application said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow - across 10 states.
The phase 3 clinical trial application has proposed a dose of 0.5 ml on day 0 and 28, sources said.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.
Earlier, an expert panel at the Central Drugs Standard Control Organisation (CDSCO) had recommended granting permission for conducting phase 3 clinical trials of 'Covaxin' with certain conditions.
The recommendation was given 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, official sources said.
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.
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) while 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 DCGI had given permission to BharatBiotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.
(With inputs from PTI)
