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- March 3, 2021: Bharat Biotech announced interim findings from the Phase 3 study testing the Company’s COVID-19 vaccine candidate, COVAXIN (also known as BBV152). This is an inactivated vaccine that requires two doses, separated by a 4-week period.
- A total of 25,800 people took part in the study. All study participants were recruited in India. More information about the study can be in Table 1 on this website.
- 43 people in the study developed laboratory-confirmed, symptomatic COVID-19 beginning 14 days after they received the second dose of the vaccine. Of these, 36 had received the placebo vaccine and 7 had received COVAXIN. Thus, the vaccine is estimated to reduce the risk of getting symptomatic COVID-19 by 80.6%.
- No serious safety concerns have been reported.
- Going forward, the Company plans to conduct final analyses when a total of 130 people in the study have developed COVID-19.
- January 3, 2021: Bharat Biotech announced that the Company’s COVID-19 vaccine candidate, COVAXIN (also known as BBV152), has been approved for emergency use in India. Approval was based on promising safety and immune response (immunogenicity) findings from early stage (Phase 1 and 2) studies involving about 1,000 study participants. Findings from these studies can be accessed using two links below.Safety and immunogenicity clinical trial of an inactivated SARS-CoV-2 vaccine, BBV152 (a phase 2, double-blind, randomised controlled trial) and the persistence of immune responses from a phase 1 follow-up report
A Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine-BBV152