Covid-19: Bharat Biotech begins phase 3 trials of Covaxin in India – health
Bharat Biotech said Monday that it has started phase 3 clinical trials of its coronavirus disease (Covid-19) vaccine candidate Covaxin in India, with 26,000 participants at 22 sites across the country.
The trial will be carried out in partnership with the Indian Council for Medical Research (ICMR), the Hyderabad-based drug maker said in a statement.
“The Phase III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a Covid-19 vaccine in India. This is India’s first phase 3 efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted in India, ”said Bharat Biotech.
The trial has been registered in the Indian Clinical Trials Registry and approved by the Comptroller General of Medicines of India (DCGI).
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The trial volunteers will receive two intramuscular injections, approximately 28 days apart. “Participants will be randomly assigned to receive Covaxin or placebo. The trial is double blind, so researchers, participants, and the company will not know who is assigned to which group. Covaxin has been evaluated in 1,000 subjects in phase I and phase II clinical trials, with promising safety and immunogenicity data, ”the company statement reads. Volunteers are those over 18 years of age.
Covaxin, the indigenous Covid-19 vaccine from India, is developed and manufactured in Bharat Biotech’s BSL-3 biocontainment facility (biosafety level 3).
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The development and clinical evaluation of Covaxin marks an important milestone for vaccination in India for a new vaccine. It is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic, ”said Suchitra Ella, Joint Managing Director of Bharat Biotech.