Phase-1 Trials of Covid-19 intranasal vaccine for Bharat Biotech to begin in Feb-March
After receiving the Emergency Use Authorization approval from the Drug Controller General of India (DCGI) for its Covid-19 vaccine Covaxin, Bharat Biotech to begin with Phase-1 clinical trials of its new intranasal antidote for the virus during February-March this year.
To develop the vaccine, Bharat Biotech has tied up with Washington University School 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," read an email reply from the city-based vaccine maker.
“The company is focusing on the intranasal vaccine as the existing vaccines require two dose intramuscular injections”, said Krishna Ella, Chairman, Bharat Biotech.
According to the company sources, Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe and The Phase-1 trials will be conducted in Saint Louis University's Vaccine and Treatment Evaluation Unit.
According to Ella, it will not only be simple to administer an intranasal vaccine but also reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive.
"One drop of vaccine in each of the nostrils is sufficient," he said.
He said that Bharat Biotech envisions to scale this vaccine to one billion doses, translating into equal number of individuals being vaccinated receiving a single-dose regimen.
Bharat Biotech after receiving the regulatory approval will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP (good manufacturing practice) facility located in Genome Valley, here, the company had earlier said.
The intranasal vaccine candidate has shown unprecedented levels of protection in mice studies and the technology and data having been already published in the prestigious scientific journal 'Cell' and in an editorial in 'Nature', the company had said.
Bharat Biotech has successfully completed enrollment of 25,800 volunteers for the Phase-3 trials of its Covid-19 vaccine Covaxin.
Meanwhile, a second dry run to check the best way to vaccinate people against the virus and detect loopholes in logistics and training took place across 737 districts in the country today.