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

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Hyderabad: Buoyed by the Emergency Use Authorisation approval from the Drug Controller General of India (DCGI)for its COVID-19 vaccine Covaxin, Bharat Biotech has mentioned Phase-1 medical trials of its new intranasal antidote for the killer virus will start throughout February-March this 12 months.

Besides Covaxin, BharatBiotech has been actively engaged on creating one other vaccine, for which it has tied up with Washington UniversitySchool of Medicine in St Louis for the novel “chimp-adenovirus” (Chimpanzee adenovirus), a single dose intra nasal 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 electronic mail reply from the city-based vaccine maker informed PTI.

Phase I human medical trials will probably be performed in India, Bharat Biotech added.

“The company is focusing on the intranasal vaccine as the existing vaccines require two dose intramuscular injections”

— Krishna Ella, Chairman, Bharat Biotech

The Phase-1 trials will probably be performed in Saint Louis University’s Vaccine and Treatment Evaluation Unit, the corporate sources mentioned including Bharat Biotech owns the rights to distribute the vaccine in all markets besides USA, Japan and Europe.
Krishna Ella, Chairman of Bharat Biotech had earlier mentioned the corporate is specializing in the intranasal vaccine as the prevailing vaccines require two dose intramuscular injections and a rustic like India wants 2.6 billion syringes and needles which can add as much as air pollution.

An intranasal vaccine won’t solely be easy to manage however cut back using medical consumables resembling needles, syringes, and so forth., considerably impacting the general price of a vaccination drive, he had mentioned.

“One drop of vaccine in each of the nostrils is sufficient,” he had mentioned.

“An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes”

— Ella

According to him, holding a number of points in thoughts BharatBiotechtied up withWashingtonUniversitySchool of Medicine for the one dose intra nasal vaccine for COVID-19.

He had mentioned Bharat Biotech envisions that it might scale this vaccine to at least one billion doses, translating into equal variety of people being vaccinated receiving a single-dose routine.

BharatBiotech, upon acquiring required regulatory approval, will pursue additional phases of medical trials in India and undertake giant scale manufacture of the vaccine at its GMP (good manufacturing observe) facility positioned in Genome Valley, right here, the corporate had earlier mentioned.

The intranasal vaccine candidate has proven unprecedented ranges of safety in mice research and the expertise and information having been already revealed within the prestigious scientific journal ‘Cell’ and in an editorial in ‘Nature’, the corporate had mentioned.

Bharat Biotech has efficiently accomplished enrollment of25,800 volunteers for the Phase-Three trials of its COVID-19 vaccine Covaxin.




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