An expert panel at the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission for conducting phase 3 clinical trials of its indigenously developed Covid-19 vaccine with certain conditions.
The vaccine — ”Covaxin” — is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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.
“The DCGI is likely to give its final nod by tonight or tomorrow,” they said.
The firm in its application has said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites across 10 states including places like Delhi, Mumbai, Patna, and Lucknow.
The Hyderabad-based vaccine maker had on October 2 sought the DCGI”s permission to conduct phase 3 randomized double-blind placebo-controlled multicentre trial of its COVID-19 vaccine.
But it 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.
The phase 3 clinical trial application has proposed a dose of 0.5 ml on days 0 and 28, 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 evidence, 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 an asymptomatic 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/ageusia, oxygen saturation of 94 percent 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 Bharat Biotech to conduct phase 1 and 2 clinical trials of its Covid-19 vaccine.