Bharat Biotech to begin Phase-1 trials of its intranasal vaccine for COVID-19 in February-March

Boosted by the Drug Controller General of India (DCGI) approval of the Emergency Use Authorisation for its COVID-19 vaccine Covaxin, Bharat Biotech has announced that Phase 1 clinical trials of its latest virus antidote would start in February-March 2021.

Covaxin, Bharat Biotech has been involved in the development of another vaccine along with the Washington University School of Medicine in St. Louis for the innovative 'chimp-adenovirus' single-dose COVID tranasal vaccine 19.

Preclinical trials for toxicology, immunogenicity, and challenge studies have been performed for BBV154 (intranasal COVID-19 vaccine).

In the USA and India, these researches have been performed. in Feb-March 2021, phase I human clinical trials will begin. In India, phase I human clinical trials will be carried out, Bharat Biotech added.

Phase 1 trials will be performed in the Vaccine and Treatment Evaluation Unit of Saint Louis University, company sources said that adding Bharat Biotech owns the rights to distribute the vaccine across markets except Europe, USA and Japan.

Mr. Krishna Ella, Chairman of Bharat Biotech had earlier said, “As the current vaccines need two doses of intramuscular injections and a region such as India needs 2.6 billion syringes and needles that can add up to pollution, the company focuses on the intranasal vaccine.”

In addition to being easy to administer, an intranasal vaccine will minimise the use of medical consumables such as needles, syringes, etc., which will have a direct effect on the overall cost of a vaccine.

He said, “In each of the nostrils, one drop of vaccine is sufficient.”

According to him, Bharat Biotech associated with the Washington University School of Medicine for the single dose intranasal vaccine for COVID-19, keeping several challenges in mind. Bharat Biotech plans to scale this vaccine to one billion doses, resulting in an equivalent number of vaccinated individuals receiving a single-dose regimen.

Upon gaining the requisite regulatory approval, Bharat Biotech will undertake further phases of clinical trials in India and conduct large-scale development of the vaccine at its Genome Valley GMP (good manufacturing practise) plant, the company said earlier.

In mice trials, the intranasal vaccine candidate has shown unparalleled levels of safety and the technology and data have already been published in the prestigious scientific journal 'Cell' and in an editorial in 'Nature,' the company said.

For the Phase 3 trials of its COVID-19 vaccine Covaxin, Bharat Biotech has successfully completed the enrolment of 25,800 volunteers.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.