Bharat Biotech launches iNNCOVACC, world’s first intranasal Covid-19 vaccine

New Delhi: Bharat Biotech International, a global vaccine leader launched the world’s first COVID intranasal vaccine for primary series and heterologous booster, iNCOVACC (BBV154), on January 26, 2023.

The vaccine was launched by Dr. Mansukh Mandaviya, Minister for Health and Family Welfare, in the presence of Dr. Jitendra Singh, Minister for Science & Technology, on the occasion of Republic Day.

iNCOVACC is available on CoWIN, and priced at Rs 800 for private markets and Rs 325 for supplies to Govt of India and State Governments. The vaccine 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 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.

As a 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.

Clinical trials and extensive humoral and cell mediated responses were conducted to evaluate iNCOVACC as a primary dose schedule, and as 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.

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. Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for the vaccine to be administered for primary series and as heterologous booster doses.

Dr. Mansukh Mandaviya, Minister for Health and Family Welfare, said, “The launch of iNCOVACC vaccine is an important milestone in Atma Nirbhar Bharat vision. Today, India contributes 65% of the vaccine need of the world, saving lives of children, adolescents and adults. It is also great to note that, in global dialogue, India’s manufacturing, research and innovation capabilities are admired. India will not be just known as the pharmacy of the world, but will be known for its research and innovation in vaccines.”

Dr. Jitendra Singh, Minister for Science & Technology, said, “Bharat Biotech and the Department of Science and Technology are Natural Collaborators, and we owe this vaccine innovation to the world. India has taken the lead in vaccine innovation, as we have a legacy of dealing with communicable diseases. He added, iNCOVACC nasal vaccine launched today will be a huge success, with Bharat Biotech’s expertise, and diligence it will be a success story.”

Dr. Krishna Ella, Executive 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 & develop novel vaccine technologies for combating infectious diseases & 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.”

Mrs. Suchitra Ella, MD, Bharat Biotech 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.”

iNCOVACC was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated 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 is exciting to see the deployment of iNCOVACC in India as a nasally delivered vaccine and booster,” said Dr. Michael S. Diamond, MD, PhD, of Washington University in St. Louis, who co-developed the nasal vaccine technology with Washington University colleague Dr. David T. Curiel, MD, PhD. “The continued waves of COVID-19 infection necessitate new strategies to overcome transmission. By generating immunity in the upper respiratory tract at the portal of entry of the virus, this vaccine has the potential to better limit spread of the virus than other approaches. Washington University licensed the vaccine technology to Bharat in 2020 for further development.”