India’s first intranasal anti-Covid vaccine, manufactured by Hyderabad-based Bharat Biocon, has been approved by the Drugs Controller General of India (DGCI).
The vaccine can be used for primary immunization in emergency situations in people above 18 years of age, as per the Ministry of Health.
“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 Ji’s leadership,” said Union health minister Mansukh Mandaviya.
He said India will defeat Covid-19 disease with a science-driven approach and public participation.
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
Last month, the drug maker said it conducted two separate and simultaneous clinical trials to evaluate the clinical efficiency of its needle-free vaccine for primary usage (two doses), and a heterologous booster dose for subjects who have already received two doses of the two commonly administered Covid vaccines in India – Covishield and Covaxin.
For the vaccine meant for primary use, Bharat Biotech conducted phase 3 trials in 3100 subjects at 14 sites across India to evaluate its safety and immunogenicity.
The company, headed by Krishna Ella, has said that the intranasal Covid vaccine, BBV154, has proven to be safe, well-tolerated, and immunogenic in phase 3 trials.
Being an intranasal vaccine, BBV154 may produce local antibodies in the upper respiratory tract which may provide the potential to reduce infection and transmission, it said on August 15.
The nasal delivery system for the vaccine has been designed and developed to be cost-effective in low and middle-income countries.
The vaccine has been developed in partnership with Washington University in St. Louis. “The university had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy,” Bharat Biotech informed.
Product development related to pre-clinical safety evaluation, large-scale manufacturing, formulation, and delivery device development was conducted by Bharat Biotech.
The Central government partly funded product development and clinical trials through the Department of Biotechnology’s, COVID Suraksha program, the company revealed.