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India's first intranasal Covid vaccine by Bharat Biotech received DCGI approval on Tuesday for primary immunization against the infection for people above the age of 18. Lauding the achievement, Health Minister Dr Mansukh Mandaviya said, it is a ‘Big Boost to India's Fight Against COVID-19’. The intranasal vaccine for COVID-19 by Bharat Biotech is first of its kind needle-free vaccine.

Mandaviya tweeted, 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.

Bharat Biotech said in a statement "Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that intranasal COVID vaccine (BBV154), has received approval under Restricted Use in Emergency Situation for ages 18 and above."

All that you need to know about iNCOVACC?

The iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results.

This vaccine has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries.

The chairman of Bharat Biotech called the approval a matter of pride for the organisation and said that the intra-nasal vaccine would be a global game changer.

"Despite the lack of demand for COVID-19 vaccines, we continued product development in intra-nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases. We thank the Ministry of Health, the CDSCO, the Department of Biotechnology Govt of India, and Washington University St. Louis for their support and guidance," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.

The intranasal vaccine is a heterologous booster dose.

"Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India," the statement added.

"Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG's through ELISA's. To evaluate vaccines taken through the intranasal route, IgA's were evaluated by ELISA in serum and saliva. An evaluation was also carried out for the ability iNCOVACC to elicit long-term memory T and B cell responses against the ancestral and omicron variants," it added.

(With inputs from agencies)

 

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