The Central Drugs Standard Control Organisation has issued restricted emergency use approval to Hyderabad-based Bharat Biotech’s recombinant nasal vaccine for primary immunisation against Covid-19. The vaccine, which has advantages of easy nasal delivery, is claimed to be more cost-effective.
Announcing the approval, Union Health Minister Dr Mansukh Mandaviya said “it is 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 approved by @CDSCO_India_INF for primary immunisation against Covid-19 in 18+ age group for restricted use in emergency situation,” he tweeted.
“This step will further strengthen our collective fight against the pandemic,” he said.
India has harnessed its science, R&D, and Human Resources in the fight against Covid-19 under Prime Minister Narendra Modi’s leadership. “With the science-driven approach and Sabhka Prayas, we will defeat Covid-19,” he said. BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated earlier in phase I and II clinical trials with successful results. BBV154 has been specifically formulated to allow intranasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries, said the company during the time.
BBV154 was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy. Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2- dose) schedule and a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered Covid vaccines in India.
BBV154 has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunization protect from emerging concern variants, it added.