Bharat Biotech, the company that has manufactured the India’s first indigenous vaccine Covaxin , is all set to seek an approval for the third phase of the clinical trials of the nasal vaccine(BBV154). The company is trying to seek the approval of the DGCI (Drugs Controller General of India) to administer this as a booster dose.
A company source told the PTI that “We have submitted the Phase 3 trial application to the DGCI. Phase 3 trial will be on those who have been administered with any two doses of Covid vaccine. An intranasal vaccine as a booster dose would be easier to administer in mass vaccination campaigns and has potential to prevent transmission.”
Phase 1 trial was conducted on 400 healthy individuals between ages 18-20 years. Phase 2 was completed on 650 individuals in 10 centres across the country.
Also, the Central drugs Standard Control organisation (CDSCO) has also approved the extension of the shelf life of Bharat Biotech’s Covaxin for up to 12 months from the date of manufacture.
