Bharat Biotech’s nasal COVID-19 vaccine gets approval for phase 2/3 trial: Know all about it

WHO approval on Bharat Biotech's Covaxin EUL likely by October
Bharat Biotech

New Delhi: India’s drug regulator has given its approval to Pharmaceutical major Bharat Biotech to carry out mid-to late-stage trials of their nasal COVID-19 vaccine candidate, the Union ministry of science has said.

“This is the first of its kind Covid-19 jab to undergo human clinical trials in India,” the ministry said.

Bharat Biotech’s nasal COVID-19 vaccine

“BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. BBIL has in-licensed technology from Washington University in St Louis, USA,” it added.

Trials have been conducted in the early stage of the candidate vaccine BBV154 in subjects between the ages of 18 to 60 years. The company said the vaccine doses given to healthy volunteers were well tolerated.

“Bharat Biotech’s BBV154 Covid Vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials,” said Renu Swarup, chairperson of the Biotechnology Industry Research Assistance Council.

Covaxin’s efficacy

In January this year, Bharat Biotech’s Covaxin COVID-19 vaccine received a nod for emergency use in India. Its doses are being administered via injection as part of the country’s vaccination drive.

Bharat Biotech's nasal COVID-19 vaccine gets approval
Image credits: Bharat Biotech

Bharat Biotech’s Joint Managing Director Suchitra Ella said on Thursday that the Hyderabad-based firm has provided 75 million doses of Covaxin so far, with more expected to be supplied this month.

Furthermore, she said that Covaxin is 65% effective against the B.1.617.2 Delta variant of COVID-19.

“Our second site is at Ankleshwar-based manufacturing plant. Sample batches are ready, it’ll go to CDL Kasauli this month for quality testing,” Ella added.

In July this year, Bharat Biotech has vowed to provide more than 500 million Covaxin doses to the government as part of the national immunisation program.

At a virtual meeting organized by the Confederation of Indian Industry, Ella said that the company’s facilities in four cities: Hyderabad, Bengaluru, Pune and Ankleshwar, are currently producing Covaxin.

While announcing the final analysis of Covaxin, Bharat Biotech said the vaccine showed 77.8% efficacy against symptomatic COVID-19 and 65.2% protection against B.1.617.2 Delta variant.

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