DCGI gives EUA to India’s first nasal vaccine against COVID-19

The Drugs Controller General of India (DCGI) has given Emergency Use Authorisation (EUA) to India’s first intra-nasal vaccine against COVID-19, manufactured by Bharat Biotech.

The vaccine has been supported by the Department of Biotechnology (DBT) and Biotechnology Industry Research and Assistance Council (BIRAC) under the aegis of Mission COVID Suraksha, 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.

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

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

Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, speaking on the subject said, “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 immunisation 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…..”