The intranasal Covid-19 vaccine BBV154 has successfully completed phase-III and booster dosage trials, according to Bharat Biotech International Ltd (BBIL), and it has been shown to be safe.
The business reported that it had carried out two independent studies for its intranasal Covid vaccine, one as a primary dosage schedule and another as a booster dose, for patients who had received two doses of the two Covid vaccinations that are frequently delivered in India.
According to a statement from BBIL, it has been shown in controlled trials to be secure, well-tolerated, and immunogenic in participants.
According to the firm, national regulatory authorities have received the data from both of the Phase III human clinical trials that have been filed for approval.
“With an easy-to-use formulation and delivery system, this intranasal vaccine will ease deployment in mass immunisation programmes if it is authorised. Additionally, vectored vaccines speed up the creation of targeted vaccinations in response to worrying new variants “Suchhitra K. Ella, joint managing director of Bharat Biotech, remarked
According to the business, its “BBV154” has been specifically developed to enable intranasal delivery and was created to be economical in low- and middle-income nations.
Bharat Biotech added that it has created sizable manufacturing capabilities at numerous sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana. It is stable at 2.8 degrees Celsius, permitting simple storage and transportation.
According to BBIL, the principal dosage schedule phase III studies for safety and immunogenicity in over 3,100 participants were carried out in 14 trial sites across India and compared with COVAXIN, the company’s current COVID-19 vaccine.
A booster dosage (3rd dose) of the BBV154 intranasal vaccine was given to the participants in the trials for booster dose investigations, which were carried out at nine sites across India with roughly 875 people.
The recombinant adenoviral vectored constructs for the intranasal Covid vaccination were created, developed, and tested for efficacy in preclinical research by Washington University St. Louis, the company claimed.
However, BBIL was in charge of product development for preclinical safety assessment, large-scale manufacturing scale-up, formulation development, and delivery device development, including human clinical trials.
The business claimed that the COVID Suraksha initiative of the Department of Biotechnology had received partial funding from the Indian government for product development and clinical studies.
