BHARAT BIOTECH SENDS PROPOSAL FOR TRIALS OF NASAL VACCINE
NEW DELHI: 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 on 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.
NEW DELHI: 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 on 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 chimpadenovirus, 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.