Hyderabad, July 20 (FN Agency) Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, on Wednesday announced that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine, has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials. The study has been accepted and published in Nature Scientific Reports, a high impact factor journal. The study was conducted in 184 subjects, who were randomized 1:1 and received either a booster dose of BBV154 or a placebo, Rs6 months after the primary series of 2 doses, Hyderabad-based BBIL said in a statement here.
Subjects were evaluated for safety, neutralizing antibody responses against variants of concern, binding antibodies against spike protein, RBD, N proteins, and for memory T and B cell responses to demonstrate cell mediated immunity. Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “Our team has now demonstrated that COVAXIN is a multi epitope vaccine with antibodies against spike, RBD and N proteins. Post booster dose, it has proven neutralizing antibody responses against variants of concern and long term protection through memory T and B cell responses. We have now achieved our goal of developing a safe and efficacious vaccine with long term protection against a spectrum of variants.” COVAXIN , is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses, making it truly a universal vaccine. COVAXIN is a ready to use liquid vaccine, stored at 2-8C, with 12 months shelf life and multi dose vial policy. Whole virion inactivated vaccines have proven to be safe, tolerable with a safety track record of several decades. Several paediatric vaccines manufactured using this platform technology are utilized in routine immunization for primary immunization and booster doses.
Several flu vaccines also utilize this manufacturing platform technology, which is safe and effective for repeated annual immunization doses and boosters. Bharat Biotech has a stockpile of more than 50 million doses of COVAXIN ready to be distributed as required. Located in Genome Valley in Hyderabad, BBIL has built world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution. Having delivered more than 4 billion doses of vaccines worldwide, BBIL continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis (JENVAC®? ), Rabies, Chikungunya, Zika, Cholera, and the world’s first tetanus toxoid conjugated vaccine for Typhoid.