Bharat Biotech to launch Covaxin in second quarter of next year
Bharat Biotech is planning to launch its vaccine for COVID-19 in the second quarter next year if it gets the requisite approvals from the Indian regulatory authorities, a top company official said. It said its immediate focus is to conduct the Phase 3 trials successfully across sites in the country. The company's vaccine candidate — Covaxin — has been developed in collaboration with the Indian Council of Medical Research (ICMR) — National Institute of Virology (NIV) using inactivated Sars-Cov-2, the virus that causes COVID-19. The virus was isolated in an ICMR lab. "If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Q2 of 2021," said Bharat Biotech International Executive Director Sai Prasad. After the company received approval from the Drugs Controller General of India to conduct Phase 3 clinical trial to establish the efficacy of the vaccine candidate, it has begun site preparatory exercises for Phase 3, recruitment and dosage will begin in November, he added.
Covid vaccine trials on 1,000 volunteers in AMU from November 14
One thousand volunteers have been invited to enrol at the Aligarh Muslim University (AMU) medical college to participate in the clinical trials for Covaxine that will begin from November 14 and continue till the end of January. These will be a series of large-scale clinical trials held at AMU's Jawaharlal Nehru Medical College aimed at evaluating the safety and efficacy of the Covid-19 vaccine study led by Bharat Biotech. AMU Vice Chancellor Professor Tariq Mansoor said that JNMC has enhanced the preparations for the trials after a nod from the Indian Council of Medical Research. Appealing volunteers from all age groups and socio-economic strata to participate in the clinical trials, Mansoor said, "By volunteering for a trial or study, you get a chance to participate in ground-breaking research and contribute to developing better cures and treatment options. “People from various backgrounds are invited to be part of the solution and help end the pandemic.”