Bharat Biotech has asked permission from the Drugs Controller General of India (DCGI) for conducting Phase 3 clinical trials of its intranasal Covid vaccine candidate, BBV 154. The company believes that nasal vaccines will be suitable for booster dose and can be incorporated in mass vaccination programmes.
“We have submitted Phase 3 clinical trial application to the DCGI. Phase 3 trial will be on those who have been administered with any two doses of Covid vaccine,” an official from the company told BusinessLine.
Krishna Ella, CMD, Bharat Biotech, recently said that the vaccine was capable of stopping virus transmission and would involve “a lot of new science which even the Western world is not aware of.”
Bharat Biotech recently completed Phase 2 trials of the world’s first intranasal vaccine on 650 volunteers in 10 centres across the country. Under Phase 1, trials were conducted on 400 healthy individuals aged between 18 and 20.
Bharat Biotech’s vaccine candidate is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2-vectored vaccine based on a new technology licensed from the Washington University. The company is working on a cocktail method of administering using a combination of intramuscular and nasal in a first-of-its-kind approach.