DCGI clears India’s FIRST Intranasal Covid-19 vaccine for restricted emergency use

New Delhi: India’s fight against the coronavirus got a major boost on Tuesday after the Drugs Controller General of India (DCGI) gave its nod to Hyderabad-based Bharat Biotech's intranasal Covid vaccine for restricted emergency use in those aged above 18 years.

"Big Boost to India's Fight Against COVID-19! Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation," Union Health Minister Mansukh Mandaviya said in a tweet.

Big Boost to India's Fight Against COVID-19!

Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.

— Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022

The Union Health Minister said this step will further strengthen "our collective fight" against the pandemic. “India has harnessed its science, research and development (R&D), and human resources in the fight against COVID-19 under Prime Minister Narendra Modi's leadership,” he said.

"With the science-driven approach & Sabka Prayas, we will defeat COVID-19," Mandaviya also said.

Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "We are proud to announce the approval of iNCOVACC, a global game changer in intranasal 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."

Phase III trials of the vaccine were conducted for safety, immunogenicity in about 3,100 subjects, in 14 trial sites across India, Bharat Biotech said.

The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse reaction reported so far, company sources had said.