Bharat Biotech to Begin Phase-1 Trials of Intranasal COVID-19 Vaccine in Feb-March

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. Also Read – Bharat Biotech Announces Completion of Volunteer Enrollment For Phase-3 Clinical Trials of Covaxin

Besides Covaxin, Bharat Biotech has been actively engaged on growing one other 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 intranasal vaccine for COVID-19. Also Read – ‘Crucial Time to Save Lives’: Serum Institute, Bharat Biotech Pledge Smooth Vaccine Rollout

“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 e mail reply from the city-based vaccine maker advised P T I. Also Read – Zee News Reporter Pooja Makkar Becomes First Journalist to Get Bharat Biotech’s Covaxin | Watch

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

The Phase-1 trials shall 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 up to air pollution.

An intranasal vaccine won’t solely be easy to administer however cut back the use of medical consumables equivalent to needles, syringes, and so on., 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.

According to him, conserving a number of points in thoughts BharatBiotech tied up with Washington University School of Medicine for the one dose intranasal vaccine for COVID-19.

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

BharatBiotech, upon obtainingrequired regulatory approval, will pursue additional phases of medical trials in India and undertake massive scale manufacture of the vaccine at its GMP (good manufacturing follow) facility situated 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 knowledge having been already printed in the celebrated 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-3 trials of its COVID-19 vaccine Covaxin.

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