25,800 Volunteers Enrolled for Covaxin Phase III Clinical Trials
Headquartered in Hyderabad, Bharat Biotech, the renowned vaccine manufacturer has finished its recruitment of volunteers for the phase III trials of Covaxin. The firm has concluded its recruitment after achieving the sample size it has initially promised to the ethics committee. It is to be noted that Bharat Biotech has recruited 25,800 participants, the targeted number of volunteers.
Addressing the enrollment for phase III clinical trials, Head of Community Medicine and Principal Investigator of the trial at AIIMS, Delhi, Dr. Sanjay Kumar Rai, said, "AIIMS has achieved around 99 per cent of the promised target. We have finished our enrollment process after accomplishing the target in total."
The enrollment process for Covaxin, the Covid-19 vaccine faced certain challenges in terms of the number of volunteers. Where many sites had a smaller number of volunteers for the phase 3 study, there were a few sites that registered volunteers in abundance. While AIIMS Patna, undertook around 1,400 participants instead of 1,000, AIIMS Delhi and several other clinical sites faced shortage of volunteers.
Phase III study of Covaxin, which initially included 25 clinical sites across the country, inducted multiple sites in December last week due to shortage of participants. It is to be noted that the trial commenced with three sites each in Aligarh Muslim University (U.P), ICMR-National Institute of Cholera and Enteric Diseases (West Bengal), and Directorate of Public Health and Preventive Medicine (Tamil Nadu) on November 10.
The update regarding Covaxin, the novel coronavirus vaccine achieving the desired target has come after the received approval for restricted emergency use by drug regulators in India.
Covaxin is India’s first indigenous, inactivated coronavirus vaccine manufactured by Bharat Biotech, in collaboration with ICMR.
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Disclaimer: This article is issued in the general public interest and meant for general information purposes only. Readers are advised not to rely on the contents of the article as conclusive in nature and should research further or consult an expert in this regard.
