The Drugs Controller General of India (DCGI), on Tuesday, approved Bharat Biotech's anti-covid vaccine for emergency use. It is the first such vaccine in the country
Hyderabad-based firm Bharat Biotech has sought permission from the drug regulator to conduct phase-3 study of its intranasal COVID-19 vaccine in the 5 to 18 age group. On September 6, the Drugs Controller General of India (DCGI) had approved its intranasal Covid vaccine iNCOVACC for restricted emergency use in those aged above 18 years. "Now the Hyderabad based firm has submitted an application seeking permission to conduct phase-3, multicenter study to evaluate the safety, reactogenicity and immunogenicity of iNCOVACC (BBV154) in those aged 18 to 5 years," an official source told PTI. iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phase 1, 2 and 3 clinical trials with successful results, a release from the vaccine-maker said. BBV154 has been specifically formulated to allow intranasal delivery. "Being an intranasal vaccine, BBV154 may produce local antibodies in the up
Bharat Biotech did not comment on its plans to make this vaccine available for young children
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The Drugs Controller General of India (DCGI) on Tuesday approved 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 tweeted. He 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. The Hyderabad-based firm completed clinical trials of the nasal vaccine with about 4,000 volunteers and there is no side effect or adverse
Besides Bharat Biotech's nasal vaccine, India has 13 vaccines to fight against Covid-19. Two have been approved for manufacturing, while 11 have been approved for emergency use
The Hyderabad-based company claimed that BBV154 is proven to be safe, well-tolerated and immunogenic in the subjects under controlled clinical trials
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