Covaxin Maker Bharat Biotech Is Getting Ready For Clinical Trials Of Nasal Vaccine For COVID-19

Domestic drug maker Bharat Biotech which had recently received a restricted emergency approval for its COVID-19 vaccine candidate Covaxin is all set to take another major step in the fight against the pandemic.

The Hyderabad-based company is eyeing to start the Phase-1 clinical trials of its new intranasal antidote for COVID-19, as early as February-March.

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Bharat Biotech, in partnership with Washington University School of Medicine in St Louis has developed the novel "chimp-adenovirus" (Chimpanzee adenovirus), a single dose intranasal vaccine for COVID-19.

What is BBV154?

"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," an email reply from the city-based vaccine maker told PTI.

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

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The Phase-1 trials will be conducted in Saint Louis University's Vaccine and Treatment Evaluation Unit, the company sources said adding Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe.

How is it better than vaccines?

Krishna Ella, Chairman of Bharat Biotech had earlier said the company is focusing on the intranasal vaccine as the existing vaccines require two dose intramuscular injections and a country like India needs 2.6 billion syringes and needles which may add up to pollution.

An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive, he had said.

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"One drop of vaccine in each of the nostrils is sufficient," he had said.

He had said Bharat Biotech envisions that it would scale this vaccine to one billion doses, translating into equal number of individuals being vaccinated receiving a single-dose regimen.

The intranasal vaccine candidate has shown unprecedented levels of protection in mice studies and the technology and data having been already published in the prestigious scientific journal 'Cell' and in an editorial in 'Nature', the company had said.