Bharat Biotech to start Phase-1 trials of intranasal COVID-19 vaccine in Feb-March 2021

Bharat Biotech has said Phase-1 clinical trials of its new intranasal COVID-19 vaccine will commence during February-March this year.

Besides Covaxin, Bharat Biotech has been working on another vaccine in partnership with Washington University School of Medicine in St Louis for the novel “chimp-adenovirus” (Chimpanzee adenovirus), a single dose intranasal vaccine for COVID-19.

“BBV154 (intranasal COVID-19 vaccine), preclinical testing has been completed for toxicology, immunogenicity and challenge studies. These studies have been conducted in the USA and India. Phase I human clinical trials will commence during Feb-March 2021,” said Bharat Biotech to PTI.

Phase I human clinical trials will be conducted in India, Bharat Biotech added.

Company sources inform that Phase-1 trials will be conducted in Saint Louis University’s Vaccine and Treatment Evaluation Unit. Bharat Biotech owns the rights to distribute the vaccine in all markets except the US, Japan and Europe.

Dr Krishna Ella, Chairman and MD of Bharat Biotech said that the company envisions that it would scale this vaccine to one billion doses.

Bharat Biotech, upon obtaining required regulatory approval will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP (good manufacturing practice) facility located in Genome Valley, here, the company had earlier said.

The intranasal vaccine candidate has shown unprecedented levels of protection in mice studies and the technology and data have been published in scientific journal Cell and in an editorial in Nature.