First Nasal Vaccine against COVID- 19 supported by DBT-BIRAC gets emergency use authorization from India drug regulator DCGI

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Delhi, Sept 8
Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) is delighted to announce approval from DCGI for emergency use authorization first of its kind intranasal COVID-19 Vaccine to Bharat Biotech (BBIL). Supported by DBT and BIRAC under the aegis of Mission COVID Suraksha, the mission was launched by DBT and implemented by BIRAC to reinforce and accelerate COVID-19 vaccine development efforts as part of Aatmanirbhar 3.0. Scientific leadership at various levels of vaccine development was provided by DBT laboratories and BIRAC. This is the fourth success story for the Covid-19 vaccine under mission Covid Suraksha.

BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. It consists of a replication deficient ChAd vector expressing the stabilized Spike SARS-CoV-2 (Wuhan variant).

DBT’s Autonomous Institute, National Institute of Immunology (NII), New Delhi utilized their “Human Immune Monitoring and T-cell Immunoassay Platform” to examine the vaccine-induced SARS-CoV-2-specific systemic and mucosal cellular immune responses the trial participants. Interactive Research School for Health Affairs (IRSHA), Pune completed the Plaque Reduction Neutralization Assay (PRNT) to quantify the titer of neutralizing antibody for the virus from three trial sites.

Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC speaking on the subject said that “The Department through Mission COVID Suraksha, is committed to the development of safe and efficacious COVID-19 vaccines. BBV154 COVID Vaccine is the first intranasal vaccine approved by DCGI for primary immunization against COVID-19 in the 18+ age group for restricted use in emergency situation being developed in the country under Mission COVID Suraksha and adds to our repertoire of COVID-19 vaccine. This is an excellent example of Aatmanirbharta initiative of the Government of India. I congratulate our scientists for partnering with Bharat Biotech and providing scientific leadership throughout the development of first intranasal COVID-19 vaccine@.

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