CDSCO has approved a recombinant nasal vaccine for COVID-19 for restricted use in emergency situations.It is a recombinant replication deficient adenovirus vectored vaccine with a prefusion stabilised spike protein.
Dr Mansukh Mandaviya Minister of Health and Family Welfare informed today that Bharat Biotech's ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by CDSCO for primary immunization against COVID-19 in 18 plus age group for restricted use in emergency situation.
He further said that, This step will further strengthen our collective fight against the pandemic. India has harnessed its science, R&D, and human resources in the fight against COVID-19 under PM Narendra Modi's leadership.
In August, Bharat Biotech announced that its intra nasal vaccine has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.
It 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. Product development related to preclinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, were conducted by Bharat Biotech.
The Government of India partly funded product development and clinical trials through the Department of Biotechnology’s, COVID Suraksha program.
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.
