New Delhi: Bharat Biotech International Limited (BBIL) ChAd36-SARS-CoV-S intranasal Covid-19 vaccine gets emergency use nod in adults by CDCSO.
Health Minister Dr Mansukh Mandaviya call it to be a ‘Big Boost to India’s Fight Against COVID-19’
Bharat Biotech’s ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine is approved by @CDSCO_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.
The company got manufacturing and marketing approvals from the Drugs Controller General of India for its Nitric Oxide Nasal Spray as part of an accelerated approval process. “Phase 3 trial in India met the key endpoints and demonstrated reduction of viral load of 94 per cent in 24 hours and 99 per cent in 48 hours,” the official statement said.
Last month, Bharat Biotech International Limited (BBIL) had said its Covid-19 intranasal vaccine (BBV154) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III. The vaccine candidate was evaluated earlier in phase I and II clinical trials with successful results.
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.