Over 25,000 people are expected to enroll for the trial in India and they will be given two doses of the experimental vaccine 28 days apart. Preliminary results from the Covaxin trials have shown promising results. So far, the company has written to Delhi, Uttar Pradesh, Bihar, Maharashtra, Punjab, Assam and some other states, seeking permission and facilitation to initiate the phase-III trial.
“The study is in the final stages of planning. We will be providing the investigational vaccine, study protocol and all the study-related documents,” it said in a letter to states last month. Bharat Biotech’s letter said, “This study will be India’s first efficacybased Covid-19 vaccine trial evaluating the clinical outcomes. Bharat Biotech requested the states to provide their support and guidance for conducting the study. The safety and efficacy data generated from this study will be pivotal towards the licensure of Covaxin.” Covaxin is India’s first indigenously developed coronavirus vaccine candidate.
It was developed in collaboration with the Indian Council of Medical Research (ICMR) from a strain of SARSCoV-2, which was isolated by ICMR National Institute of Virology, Pune. At other sites, the process of getting approval to start phase-III trial from the ethics committee is ongoing. While AIIMS, Delhi, is likely to approach its ethics committee this week, PGI Rohtak is awaiting approval from its ethics committee. The project has been taken over by the ICMR, which means the funding for the project will now be directly done from the ICMR and not the company.