Bharat Biotech’s vaccine – Covaxin – enjoys clinical success of 81% after phase 3 trials
Bengaluru: Covaxin, Bharat Biotech’s vaccine enjoys clinical success of 81%. The result comes after phase 3 trials.
Republic TV adds that the trials involved 25,800 subjects and is the largest ever trial conducted in India, Bharat Biotech said on Tuesday. The vaccine has been in use since India began its first phase of the COVID-19 immunization drive back in January this year.
Elaborating on the details of the Phase 3 study, the pharma firm said that the participants enrolled were between the age of 18-98 years old including 2,433 over the age of 60 and 4,500 with comorbidities. "The primary endpoint of Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline," Bharat Biotech added.
"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Bharat Biotech Chairman and Managing Director Krishna Ella said.
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