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Bharat Biotech will begin phase 1 trials of its intranasal vaccine for Covid-19 in February-March | India News


HYDERABAD: Encouraged by the approval of the Emergency Use Authorization from the Controller General of Medicines of India (DCGI) for its Covid-19 Covaxin vaccine, Bharat Biotech has said that phase 1 clinical trials of its new intranasal antidote for the Killer virus will start during February- March of this year.
In addition to Covaxin, Bharat Biotech has been actively working on the development of another vaccine, for which it partnered with the Washington University School of Medicine in St Louis for the novel “chimpanzee 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 provocation studies. These studies have been conducted in the US and India. Phase I human clinical trials will begin between February and March 2021, “an email response from the city-based vaccine manufacturer told PT I.
Phase I human clinical trials will be conducted in India, added Bharat Biotech.
The Phase 1 trials will be conducted at Saint Louis University’s Vaccine Evaluation and Treatment Unit, company sources said, adding that Bharat Biotech owns the rights to distribute the vaccine in all markets except the US. USA, Japan and Europe.
Krishna Ella, president of Bharat Biotech, had previously said that the company is focusing on intranasal vaccine, as existing vaccines require two dose intramuscular injections and a country like India needs 2.6 billion syringes and needles that can contribute to the contamination.
An intranasal vaccine will not only be easy to administer, it will reduce the use of medical consumables like needles, syringes, etc., which will significantly affect the overall cost of a vaccination campaign, he said.
“One drop of vaccine in each nostril is enough,” he had said.
According to him, taking several issues into account, Bharat Biotech partnered with the University of Washington School of Medicine for the single-dose intranasal vaccine for Covid-19.
He had said that Bharat Biotech anticipates that it will scale this vaccine to 1 billion doses, which translates to an equal number of vaccinated people receiving a single dose regimen.
Bharat Biotech, once it gets the required regulatory approval, will continue the stages of clinical trials in India and undertake large-scale manufacturing of the vaccine at its GMP (Good Manufacturing Practice) facility located in Genome Valley, here, it said the company previously.
The intranasal candidate vaccine has shown unprecedented levels of protection in mouse studies and the technology, and the data has already been published in the prestigious scientific journal Cell and an editorial in Nature, the company had said.
Bharat Biotech has successfully completed the enrollment of 25,800 volunteers for phase 3 trials of its Covid-19 vaccine, Covaxin.

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