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

Hyderabad, Jan 8 (PTI): Buoyed by theEmergency UseAuthorisation approval from theDrug Controller General ofIndia (DCGI)for its COVID-19 vaccine Covaxin,Bharat Biotechhas said Phase-1 clinical trials of its new intranasalantidote for the killer virus will begin during February-Marchthis year.

Besides Covaxin, BharatBiotechhas been activelyworking on developing another vaccine, for which it tied upwith Washington UniversitySchool of Medicine in St Louisfor the novel ''chimp-adenovirus'' (Chimpanzee adenovirus), asingle doseintranasalvaccine for COVID-19.

''BBV154 (intranasal COVID-19 vaccine), preclinicaltesting has been completed for toxicology, immunogenicity andchallenge studies. These studies have been conducted in theUSA and India. Phase I human clinical trials will commenceduring Feb-March 2021,'' an email reply from the city-basedvaccine maker told P T I.

Phase I human clinical trials will be conducted inIndia, Bharat Biotech added.

The Phase-1 trials will be conducted in Saint LouisUniversity's Vaccine and Treatment Evaluation Unit, thecompany sources said adding Bharat Biotech owns the rights todistribute the vaccine in all markets except USA, Japan andEurope.

Krishna Ella, Chairman ofBharatBiotechhad earliersaid the company is focusing on the intranasal vaccine as theexisting vaccinesrequire two dose intramuscular injectionsand a country like India needs 2.6 billionsyringes andneedleswhich may add up to pollution.

An intranasal vaccine will not only be simple toadminister but reduce the use of medical consumables such asneedles, syringes, etc., significantly impacting the overallcost of a vaccination drive, he had said.

''One drop of vaccine in each of the nostrils issufficient,'' he had said.

According to him, keeping several issues in mindBharatBiotechtied up withWashingtonUniversitySchool ofMedicine for the single doseintranasalvaccine for COVID-19.

He had said Bharat Biotech envisions that it wouldscale this vaccine to one billion doses, translating intoequal number of individuals being vaccinated receiving asingle-dose regimen.

BharatBiotech, upon obtainingrequired regulatoryapproval, will pursue further stages of clinical trials inIndia and undertake large scale manufacture of the vaccine atits GMP (good manufacturing practice) facility located inGenome Valley, here, the company had earlier said.

The intranasal vaccine candidate has shownunprecedented levels of protection in mice studies and thetechnology and data having been already published in theprestigious scientific journal 'Cell' and in an editorial in'Nature', the company had said.

Bharat Biotech has successfully completed enrollmentof25,800 volunteers for the Phase-3 trials of its COVID-19vaccine Covaxin.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)