Suchitra K. said: “On this Independence Day, we are proud to announce the successful completion of clinical trials for the BBV154 injectable vaccine. Ella, Joint CEO, Bharat Biotech.
“If approved, this injectable vaccine will make it easier to deploy in mass immunization campaigns with an easily administered dispensing and dispensing device,” she said.
Intranasal vaccine for COVID-19
Two separate and concurrent clinical trials were performed to evaluate BBV154 as a primary dose (two doses); and a different booster dose for subjects who had previously received two doses of two commonly used COVID vaccines in India. Data from both Phase III human clinical trials have been submitted for approval to national regulators, the company said.
BBV154 (intranasal vaccine) is a replication-deficient adenovirus vector vaccine with a mutated protein that is stable prior to fusing. This vaccine candidate has been previously evaluated in phase I and II clinical trials with successful results.
Phase III major dose-scheduled trials were conducted for safety and immunogenicity in approximately 3,100 subjects, and compared with Covaxin. Tests were conducted at 14 test sites across India.
Various booster dose studies have been performed on safety and immunogenicity in approximately 875 subjects, in which booster dose (3rd dose) of BBV154 injectable vaccine was used to study study participants who had received a previously licensed COVID vaccine. Tests were carried out in nine test sites across India.
As an intranasal vaccine, BBV154 can induce local antibodies in the upper respiratory tract, which may provide the potential to reduce infection and transmission. Further studies are planned, the vaccine maker said.
BBV154 has been specially formulated to allow nasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.
The endoscope was developed in collaboration with Washington St Louis University, which designed and developed recombinant adenoviral vector constructs and evaluated them in preclinical studies for efficacy.
Bharat Biotech conducts product development involving preclinical safety assessments, large scale manufacturing, and delivery device development and construction, including human clinical trials. The Government of India partially funds product development and clinical trials through the COVID Suraksha program of the Ministry of Biotechnology.