The Central Drugs Standard Control Organisation (CDSCO) expert panel has recommended granting approval to Indian firm Bharat Biotech for conducting Phase III clinical trials of its Covid-19 vaccine, Covaxin.
The latest development is backs assessment of safety and immunogenicity data of Phase I and II clinical trials. The results were sent to the Drugs Controller General of India (DCGI) for final approval.
Developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), Covaxin derives from a strain of SARS-CoV-2 virus and uses adjuvant Alhydroxiquim-II to boost immune response.
On 2 October, Bharat Biotech submitted an application seeking approval from the DCGI to carry out Phase III randomised, double-blind, placebo-controlled, multi-centre trial of its vaccine candidate.
Bharat Biotech was advised to submit the full safety and immunogenicity data from the Phase II trial and some clarifications related to it.
In its application, the company said that the study will be conducted on 28,500 participants aged 18 years and above in 19 sites across ten states including places like Delhi, Mumbai, Patna and Lucknow.
The Phase III trial application proposed a dose of 0.5ml on the initial day and day 28.
The panel was quoted by PTI as saying: “After detailed deliberation and the available evidences, the committee recommended that permission to conduct phase III clinical trial be granted subject to the condition that the primary efficacy endpoint for symptomatic cases should be amended as below…”
On confirming suspect case, the principal investigator will analyse the clinical information to classify it as a symptomatic case.
The CDSCO recommends that two criteria must be met for a participant to be a confirmed symptomatic case. Either criteria A or B with positive RT-PCR confirmation.
Criteria A comprises factors such as difficulty in breathing, new-onset anosmia / ageusia, oxygen saturation of over 94% or escalation in supplemental O2.
Other factors include pneumonia diagnosed by chest X-ray or CT scan, evidence of shock, ICU admission / death.
Criteria B includes fever, chills, new cough, myalgia / fatigue, headache, sore throat, nausea / vomiting, diarrhoea, congestion / runny nose.
In June, DCGI granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.