Wednesday, October 27, 2021

Bharat Biotech to submit Covaxin phase-3 trial data to WHO by June 23





India’s indigenous Covid vaccine Covaxin has submitted its phase-3 clinical trial data to World Health Organization (WHO) for its authorization.  According to a report, it is likely that WHO can take Covaxin’s approval application on June 23. WHO has mentioned on its website that six other vaccines- Pfizer, AstraZeneca, Sinopharm, Moderna, Sinovac and John & Johnson have also applied for global usage. 

Bharat Biotech Limited also informed that Covaxin will also undergo phase-4 trials to meet the scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.

Covid task force chief Dr VK Paul said that phase-3 trial data of Bharat Biotech (BBL)’s Covaxin will be released in 7-8 days. He added that the Centre has much data on safety and phase-3 trials of Covaxin and Bharat Biotech on Saturday also informed that the scientific standards and commitment of Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy.

“Covaxin’s scientific standards+commitment is transparent. Academic journals, peer reviewers, NIV-ICMR-BB researchers -scientists,9 studys & data published,” BharatBiotech CoFounder & Joint MD Suchitra Ella said in a tweet

 


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