Bharat Biotech International Limited, which recently received the national drugs regulator’s emergency use approval for its injectable Coronavirus disease vaccine, has also moved an application to conduct Phase 1 clinical trials on its intranasal Covid-19 vaccine candidate.
An official in the government with knowledge of the matter said the company had sought approval to start Phase 1 trials. A decision ion the application will be taken by the Central Drugs Standard Control Organisation’s subject expert committee.
The company is likely to begin the trials around February or March, according to news agency PTI.
In September last year, Bharat Biotech had inked a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp- adenovirus, single dose intranasal vaccine for Covid-19. Bharat Biotech owns the rights to distribute the vaccine in all markets except the US, Japan and Europe.
“…We are proud to collaborate on this innovative vaccine. We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals receiving a single-dose regimen. 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,” the company had said in a statement.
The company had also said that the intranasal vaccine candidate had shown unprecedented levels of protection in mice studies; the technology and data having been published in the prestigious scientific journal Cell and in an editorial in Nature.
{{/usCountry}}The company had also said that the intranasal vaccine candidate had shown unprecedented levels of protection in mice studies; the technology and data having been published in the prestigious scientific journal Cell and in an editorial in Nature.
{{/usCountry}}The logic behind taking an intranasal route is that both influenza and Covid-19 follow the same pattern of infection-- nose and mouth route into the lungs, which is why having mucosal immunity is important and the vaccine will also use the same nasal (drop) route.
“The ideal vaccine in a pandemic should have an easy delivery mechanism that can reach easily to the villagers; even an anganwadi worker should be able to give it to the villagers. Look at the polio vaccine, it’s a great success because of the oral drop; it reached the last mile because of easy delivery of the vaccine. Similarly, nasal drop will work better. Also, the safety of the platform has been established in humans already,” Krishna Ella, chairman and managing director of Bharat Biotech, had said in an earlier interview to HT.
The company has vast experience in developing pandemic vaccines that includes H1N1, Zika, Chikungunya, and now the Covid-19 vaccine.
“Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines. It is prudent for Bharat to be involved in diverse but tenable projects to provide a much-needed vaccine against Covid-19 reaches all citizens of the world,” Ella added.