Bharat Biotech announced monday the start of phase 3 clinical trials of its candidate coronavirus vaccine (Covid-19), Covaxin, India.
The trial will feature 26,000 participants at 22 sites across the country and will be conducted in partnership with the Indian Medical Research Council (ICMR).
“Phase III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR. This is the largest clinical trial for a Covid-19 vaccine in India. This is the first Phase 3 efficacy in India for a Covid-19 vaccine, and the largest Phase III efficacy trial ever conducted in India,” Bharat Biotech said in a statement.
The trial was recorded in the Indian Clinical Trial Registry and was approved through the Indian Comptroller General of Medicines (DCGI).
“Trial volunteers will get two intramuscular injections with a difference of approximately 28 days. Participants will be randomly assigned to obtain Covaxin or a placebo. The trial is double-blind, so researchers, participants, and society won’t know who’s assigned to which group. it has been evaluated in 1000 subjects in Phase I and Phase II clinical trials, with promising protection and immunogenicity data,” the company continued.
Trial volunteers are adults over the age of 18.
Covaxin, the indigenous indigenous candidate vaccine Covid-19 through Bharat Biotech is being developed in collaboration with the Medical Research Council of India (ICMR) – National Institute of Virology (NIV). This indigenous inactivated vaccine was developed and manufactured at Bharat Biotech’s Bio-Safety. Level 3 biological containment facility (BSL-3).
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Covaxin is a highly purified and inactivated vaccine, manufactured on a vero mobile production platform with a history of protection of more than three hundred million doses supplied.
“Covaxin’s progression and clinical evaluation marks a vital milestone for vaccination in India for a new vaccine. It is vital for Indian corporations to innovate and expand indigenous vaccines, especially a pandemic. Covaxin has attracted interest from several countries around the world for its materials and introduction,” said Suchitra Ella, Deputy Managing Director of Bharat Biotech.
Participating volunteers, who are vaccinated in phase trials, will be monitored for the onset of Covid-19 disease.
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