- Bharat Biotech to expand its trials for Covid vaccine, Covaxin
- Till now, 21 sites have been shortlisted.
- The final stage trials are expected to begin from the end of November.
THD NewsDesk, Hyderabad: As reported by Economic Times, Bharat Biotech is hoping to expand Phase-III trials of its potential Covid-19, Covaxin. The report indicates that Hyderabad-based Bharat Biotech is all set to add more sites to the already shortlisted 21. To conduct the trials, the pharmaceutical firm has received the approval of the drug regulatory authority.
So far, the results inferred from the preliminary trials conducted have been promising. The last-stage clinical trials of Covaxin are due to start by the end of November.
The trial is expected to have over 25,000 participants who will be administered two doses of the potential vaccine with a gap of 28 days in between. Bharat Biotech has till now approached the states of Delhi, Uttar Pradesh, Bihar, Maharashtra, Punjab, Assam and some other states seeking permission and assistance to commence 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,” said the Bharat Biotech’s letter.
“This study will be India’s first efficacy-based19 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.
Covaxin has been developed in close partnership with the Indian Council of Medical Research (ICMR). The vaccine has been produced from a strain of SARS-CoV-2 that was separated by the ICMR National Institute of Virology, Pune.
The ICMR has taken charge of the project and will be taking care of the finances to fund the clinical trials, not the company. The process of securing approval is continuing. In all likelihood, AIIMS Delhi would approach its ethics committee in a week while PGI, Rohtak is still waiting for the approval from its ethics committee.
Source: Economic Times