Buoyed by the Emergency Use Authorisation approval from the Drug Controller General of India (DCGI)for its COVID-19 vaccine Covaxin, Bharat Biotech has said Phase-1 clinical trials of its new intranasal antidote for the killer virus will begin during February-March this year.
Besides Covaxin, Bharat Biotech has been actively working on developing another vaccine, for which it tied up with Washington University School of Medicine in St Louis for the novel "chimp-adenovirus" (Chimpanzee adenovirus), a single dose in tranasal 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," an email reply from the city-based vaccine maker told P T I.
Phase I human clinical trials will be conducted in India, Bharat Biotech added.
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.
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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.
"One drop of vaccine in each of the nostrils is sufficient," he had said.
According to him, keeping several issues in mind Bharat Biotech tied up with Washington University School of Medicine for the single dose intranasal vaccine for COVID-19.
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.
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 having been already published in the prestigious scientific journal 'Cell' and in an editorial in 'Nature', the company had said.
Bharat Biotech has successfully completed enrollment of 25,800 volunteers for the Phase-3 trials of its COVID-19 vaccine Covaxin.
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