COVID-19 Vaccine | Bharat Biotech releases final analysis from Phase 3 trial data, Covaxin 65% effective against Delta variant

Covaxin was found to be 65 percent effective against the B.1.617.2 COVID-19 strain or Delta variant of the coronavirus disease. (File image of the Covaxin COVID-19 vaccine)

Covaxin maker Bharat Biotech on July 3 releases Phase 3 trial results and claimed vaccine efficacy of 78.8 pc against COVID-19.

“COVAXIN Proven SAFE in India's Largest Efficacy Trial,” the company tweeted on July 3.

COVAXIN® Proven SAFE in India's Largest Efficacy Trial. Final Phase-3 Pre-Print Data Published on https://t.co/JJh9n3aB6Vpic.twitter.com/AhnEg56vFN

— BharatBiotech (@BharatBiotech) July 2, 2021

Bharat Biotech claims they conducted the largest efficacy trial in India with 25,800 participants across 25 trial sites.

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

Phase III data has found Covaxin to be 78 percent effective against mild, moderate and severe COVID-19

It was found to be 93 percent effective against severe COVID-19 – reducing hospitalisations.

The vaccine was found to be 63 percent effective against asymptomatic COVID-19 transmission.

It was also found to be 65 percent effective against the B.1.617.2 COVID-19 strain or Delta variant of the coronavirus disease.

The company said Covaxin has been “well-tolerated” among participants and showed “minimal adverse effects post-immunisation”

The study has not yet peer-reviewed. It has been published on medrxiv here.

Meanwhile, the Hyderabad-based firm has applied to the World Health Organization (WHO) for the emergency-use listing of its coronavirus vaccine candidate Covaxin, which is among the three COVID-19 vaccines currently being administered in India. Covaxin was granted restricted emergency use approval in 'clinical trial mode' on January 2.

The vaccine-maker submitted its Expression of Interest (EOI) on April 19 and a pre-submission meeting is slated to be held in May-June 2021, as per key WHO documents.

The data released today is significant because as of now, vaccine beneficiaries who have been fully vaccinated by both doses of Bharat Biotech’s Covaxin, may not be allowed to go on international travel, as the vaccine produced by Bharat Biotech has not been included in WHO’s Emergency Use Listing (EUL) yet.

As per data available on covid19.trackvaccines.org, less than 10 nations have officially approved the Covaxin. Most countries only recognise Oxford-AstraZeneca’s Covishield, manufactured by the Serum Institute of India (SII), as the required vaccine for passengers coming from India.

Further, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO), on June 22, approved the Phase-3 trial efficacy data of Bharat Biotech’s COVID-19 vaccine, Covaxin.

In April, Bharat Biotech announced that Covaxin has 78 percent efficacy, based on the interim data of 127 symptomatic COVID-19 cases from participants in the Phase-3 trials. The company said the vaccine has demonstrated 100 percent efficacy against severe cases in Phase 3 trials.