Phase 3 trial data released: Covaxin provides 65.2% protection against Delta variant

July 3: In the Phase 3 trail conducted from November 2020 to January 2021, Bharat Biotech’s Covaxin showed 65 percent efficacy as against Delta Covid variant. Bharat Biotech has just released results from its final analysis from Phase 3 trial for Covaxin Covid-19 vaccine. The Delta variant of Covid-19 was first detected in India.

Bharat Biotech which produces Covid-19 vaccine Covaxin further claimed that the vaccine demonstrates overall efficacy of 77.8 percent against symptomatic infection. Around 26,000 people had voluntered for the Phase 3 trial of Covaxin.

Placing its Phase 3 trial report, Bharat Biotech stated, “We report the clinical efficacy against COVID 19 infection of BBV152, a whole virion inactivated SARS CoV 2 vaccine formulated with a Toll like receptor 7/8 agonist molecule adsorbed to alum (Algel IMDG). Methods: We did a double-blind, randomised, multicentre, phase 3 clinical trial in 25 Indian hospitals to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Healthy adults (age 18 to 98 years) randomised 1:1 using a sponsor-supplied randomisation scheme received 2 intramuscular doses of vaccine or placebo administered four weeks apart. The primary outcome was laboratory confirmed symptomatic COVID 19, occurring at least 14 days after the second dose. Secondary outcomes were efficacy in subgroups for age (18 to < 60 years and >=60 years) and in participants with pre-existing stable medical conditions.”

Taking to its twitter handle, Bharat Biotech wrote, “COVAXIN® Proven SAFE in India’s Largest Efficacy Trial. Final Phase-3 Pre-Print Data Published on https://medrxiv.org/content/10.1101/2021.06.30.21259439v1.”

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