Bharat Biotech’s intranasal COVID-19 vaccine receives approval for emergency use in India

Bharat Biotech International Limited’s (BBIL) intranasal COVID-19 vaccine, iNCOVACC (BBV154), has received approval in India under Restricted Use in Emergency Situation for ages 18 and above.

iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a prefusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results. iNCOVACC has been specifically formulated to allow
intranasal delivery through nasal drops. The nasal delivery system has been designed and
developed to be cost effective in low- and middle-income countries.

iNCOVACC was developed in partnership with Washington University St. Louis, which had
designed and developed the recombinant adenoviral vectored constructs and evaluated
them in preclinical studies for efficacy. Product development related to preclinical safety
evaluation, large scale manufacturing scale up, formulation and delivery device
development, including human clinical trials were conducted by Bharat Biotech. Product
development and clinical trials were funded in part by the Government of India through the
Department of Biotechnology’s COVID Suraksha program.

Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as
heterologous booster dose for subjects who have previously received 2 doses of the two
commonly administered COVID vaccines in India.

Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and
serum IgG’s through ELISA’s. To evaluate vaccines taken through the intranasal route, IgA’s
were evaluated by ELISA in serum and saliva. Evaluation was also carried out for ability of iNCOVACC to elicit long term memory T and B cell responses against the ancestral and
omicron variants.

Dr. Krishna Ella, chairman & Managing Director, Bharat Biotech, said: “We are proud to
announce the approval of iNCOVACC, a global game changer in Intra Nasal vaccines
technology and delivery systems. Despite the lack of demand for COVID-19 vaccines, we
continued product development in intra nasal vaccines to ensure that we are well prepared
with platform technologies for future infectious diseases. We thank the Ministry of Health,
the CDSCO, Dept of Biotechnology Govt of India, and Washington University St. Louis for
their support and guidance. iNCOVACC has been designed for efficient distribution and
easy administration.”

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