The DCGI has approved a phase II/III trial of Bharat Biotech’s nasal Covid vaccination

The Union ministry of science announced on Friday that Bharat Biotech has received authorisation from India’s pharma regulator to undertake mid-to late-stage trials of their nasal Covid-19 vaccine candidate.

“This is the first Covid-19 vaccine to go through human clinical trials in India,” says the company “According to the ministry. ”

“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.

Early stage trials of the vaccine candidate, BBV154, has been completed in subjects aged 18 to 60 years. The company has said that the doses of the vaccine administered to healthy volunteers were found to be 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.

The company’s Covaxin Covid-19 vaccine was approved for emergency use in the country in January this year. It is being administered through an injection in the country’s inoculation drive.

Suchitra Ella, Joint Managing Director, Bharat Biotech, on Thursday, said the Hyderabad-based company has supplied 75 million doses of Covaxin so far and more will be supplied this month.

The Bharat Biotech official said that Covaxin has 65% efficacy 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.

Last month, the vaccine maker said it has committed to supply over 500 million doses of Covaxin to the government under the nationwide immunisation programme.

Speaking at a virtual meet organised by the Confederation of Indian Industry, Ella said the firm facilities in four cities – Hyderabad, Bengaluru, Pune and Ankleshwar – are currently producing Covaxin.

Covaxin demonstrated 77.8% effectiveness against symptomatic coronavirus and 65.2% protection against the B.1.617.2 Delta variant, Bharat Biotech said recently, while announcing the final analysis of the jab.