Bharat Biotech has received approval from the Central Drugs Standard Control Organisation (CDSCO) for conducting phase III clinical trials of its COVID-19 vaccine- Covaxin.
The approval is based on the 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, said the company.
The vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) 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 trial of its vaccine candidate following which the company was advised to submit the full safety and immunogenicity data from the phase II trial.
In its application, the company revealed that the study will be conducted on 28,500 participants aged 18 years and above in 19 sites across ten states including Delhi, Mumbai, Patna and Lucknow.
The phase III trial application proposed a dose of 0.5ml on the initial day and day 28. The CDSCO panel recommended that two criteria with positive RT-PCR confirmation must be met for a participant to be a confirmed symptomatic case.
Criteria A comprises factors such as difficulty in breathing, new-onset anosmia / ageusia, oxygen saturation of over 94% or escalation in supplemental oxygen. Other factors included pneumonia diagnosed by chest X-ray or CT scan, evidence of shock, ICU admission / death.
Criteria B included fever, chills, new cough, myalgia / fatigue, headache, sore throat, nausea / vomiting, diarrhoea, congestion / runny nose.