As the country marked its 74th Republic Day, Union Health Minister Dr Mansukh Mandaviya and Union Science and Technology Minister Jitendra Singh launched Bharat Biotech’s first India-made nasal Covid-19 vaccine, iNCOVACC, on Thursday.

“Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today dedicated iNCOVACC® (BBV154) to the nation, the world’s 1st COVID intranasal vaccine for Primary series and Heterologous booster,” read a release issued by the firm on Thursday.

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“Product development and clinical trials for iNCOVACC® were funded in part by the Government of India, through the Department of Biotechnology’s, Covid Suraksha Program,” the statement informed further.
The firm said it got an approval from the Central Drugs Standard Control Organization (CDSCO) “for iNCOVACC® to be administered for primary series and as heterologous booster doses”.

Happy Republic Day…. #republicday2023 #BharatBiotech #republicdayindia #RepublicDay #RepublicDayCelebrations #26january #intranasalvaccine #iNCOVACC #india #nation pic.twitter.com/8Jr1vqo64m

— BharatBiotech (@BharatBiotech) January 26, 2023

“Amid growing Covid-19 cases and emerging variants of the highly transmissible virus, a booster dose of the vaccine becomes imperative. iNCOVACC® is now available on CoWIN, and priced at INR 800 for private markets and INR 325 for supplies to Govt of India and State Governments,” the statement read.

“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,” it stated further.

Further, according to the statement, the 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, informed the pharma firm.

“As needleless vaccination, Bharat Biotech’s iNCOVACC® will be the world’s first such booster dose. India will now have more options when it comes to third doses or precautionary doses,” it said.

“Clinical trials and extensive humoral and cell-mediated responses were conducted to evaluate iNCOVACC® as a primary dose schedule, and as a heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid-19 vaccines in India. The intranasal vaccine is stable at 2-8°C for easy storage and distribution and has been designed for efficient distribution and easy pain-free administration,” it informed further.

The firm said despite the relatively low demand for Covid vaccines, “Bharat Biotech continued product development in intranasal vaccines, to be well-prepared with platform technologies for future infectious diseases. Bharat Biotech has also initiated the development of variant-specific vaccines for COVID in an attempt to be future-ready”.

“iNCOVACC® was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it 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 Technology Development Board, Govt of India has been instrumental in debt financing for commercial scale manufacturing facilities,” it said. Dr Krishna Ella, cxecutive chairman, Bharat Biotech, said, “With the rollout of iNCOVACC® today, we have achieved our goal of establishing a novel vaccine delivery platform for intranasal delivery.

It proves that India can innovate for itself and for the world. We and the country are well prepared for future Covid-19 variants and future infectious diseases. We reaffirm our commitment to India, to lead innovation and develop novel vaccine technologies for combating infectious diseases and public health globally. We have proven these capabilities and expertise time and again with innovator vaccines such as TYPBAR TCV, ROTAVAC, JENVAC, COVAXIN and others. Bharat Biotech is a leading global developer and manufacturer of vaccines with more than 7 billion doses manufactured till date.”

Suchitra Ella, MD, said, “It is exemplary that India has not only served herself during the pandemic challenges, but also a strong provider to the global platform in distributing vaccines and medicines to over 150 countries. With iNCOVACC® – the world’s 1st intranasal Covid vaccine, we are privileged to defend the nation’s health with global quality and scale.”