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Announce the approval from DCGI for emergency use authorization for Bharat Biotech’s intranasal COVID-19 vaccine

The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) are pleased to announce the approval from DCGI for emergency use authorization for Bharat Biotech’s (BBIL) first-of-its-kind intranasal COVID-19 vaccine. Supported by DBT and BIRAC under the auspices of the COVID Suraksha Mission, the mission was initiated by DBT and implemented by BIRAC to strengthen and accelerate the efforts to develop a COVID-19 vaccine as part of Aatmanirbhar 3.0. Scientific leadership at various levels of vaccine development was provided by the DBT and BIRAC laboratories. This is the fourth Covid-19 vaccine success story under the Covid Suraksha mission.

BBV154 is an intranasal replication-deficient SARS-CoV-2 vectored chimpanzee adenovirus vaccine. It consists of a replication-deficient ChAd vector expressing a stabilized Spike SARS-CoV-2 (Wuhan variant). DBT’s autonomous institute, National Institute of Immunology (NII), New Delhi used their “Human Immune Monitoring and T-cell Immunoassay Platform” to investigate vaccine-induced systemic and mucosal cellular immune responses in study participants. The Interactive Research School for Health Affairs (IRSHA), Pune completed the Plaque Neutralization Test (PRNT) to quantify the titer of neutralizing antibodies to the virus from three test sites.

Speaking on the issue, Dr Rajesh S Gokhale, Secretary DBT and Chairman BIRAC said that “The Department through the COVID Suraksha Mission is committed to developing safe and effective vaccines against COVID-19. BBV154 COVID Vaccine is the first DCGI-approved intranasal vaccine for primary immunization against COVID-19 in the 18+ age group for limited use in an emergency situation, which is being developed in the country under the COVID Suraksha mission and complements our COVID-19 vaccine repertoire. This is an excellent example of the Aatmanirbharta initiative of the Government of India. I congratulate our scientists for partnering with Bharat Biotech and providing scientific guidance during the development of the first intranasal vaccine for COVID-19@.

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