Phase 3 trial: Covaxin 77.8% effective against symptomatic COVID-19, 65.2% against Delta Variant

Hyderabad-based Bharat biotech's Covaxin has been found to be 77.8% effective against symptomatic COVID-19 in its phase 3 clinical trials. It also showed 65.2% efficacy against the Delta Plus variant. The results are based on the evaluation of 130 confirmed cases. 

The indigenously developed vaccine demonstrated 93.4% efficacy against severe symptomatic COVID-19, the company claimed.

The safety analysis demonstrated that adverse events reported post-vaccination were similar for Covaxin and the placebo. Twelve percent of subjects experienced commonly known side effects and less than 0.5% of subjects felt serious adverse events.

"Efficacy analysis demonstrates Covaxin to be 93.4% effective against severe symptomatic COVID-19. Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant," Bharat Biotech said.

COVAXIN Proven SAFE in India's Largest Efficacy Trial. Final Phase-3 Pre-Print Data Published on https://t.co/JJh9n3aB6V pic.twitter.com/AhnEg56vFN

— BharatBiotech (@BharatBiotech) July 2, 2021

Covaxin️ is a whole virion-inactivated vaccine against SARS-CoV2 and was developed by Bharat Biotech in partnership with ICMR and NIV Pune.

Phase 3 clinical trials

Phase 3 clinical trials of Covaxin were conducted at 25 sites across India.

It was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the second dose.

While 24 subjects were observed in the vaccine group, another 106 were administered placebo doses.

The age group of the vaccine trial participants ranged from 18-98 years, as per the company.

Phase 3 data has found Covaxin to be 78% effective against mild, moderate, and severe COVID-19.