India’s first Covid intranasal vaccine iNCOVACC launched on R-Day

Hyderabad: Hyderabad-based Bharat Biotech International Limited’a (BBIL) intranasal Covid-19 vaccine iNCOVACC (BBV154) was launched on Republic Day. It’s the world’s first Covid-19 intranasal vaccine for primary series and heterologous booster. iNCOVACC was launched by Dr. Mansukh Mandaviya, Union minister for health and family welfare, in the presence of Dr. Jitendra Singh, minister for science and technology.

Dr. Mansukh Mandaviya, minister of health and Family Welfare, said launching iNCOVACC is an important milestone under Atma Nitbhar Bharat’s efforts. “Today, India contributes 65% of vaccines for the world,” he said.

The minister further added, “In the global dialogue, India’s manufacturing, research, and innovation capabilities are admired worldwide. So, India will not be just known as the pharmacy of the world, but also for research and innovation.” The government of India partly funded the product development and clinical trials for iNCOVACC through the department of biotechnology’s COVID Suraksha programme.

Dr. Krishna Ella, Bharat Biotech’s executive chairman, 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 the world. We and the country are well prepared for future Covid-19 variants and future infectious diseases.”

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

CDSCO approval

Bharat Biotech received approval from the Central Drugs Standard Control Organisation (CDSCO) for iNCOVACC to be administered for primary series and as heterologous booster doses. Amid growing Covid-19 cases and emerging variants of the highly transmissible virus, a booster dose of the vaccine becomes imperative.

The vaccine is now available on CoWIN and priced at Rs. 800 for private markets and Rs. 325 for supplies to Central and state governments.

What is iNCOVACC?

iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein. This vaccine candidate was evaluated in phases 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. As a needleless vaccination, Bharat Biotech’s iNCOVACC will be the world’s first booster dose. India will now have more options when it comes to third doses or precautionary doses.

iNCOVACC was developed in partnership with Washington University, St. Louis, which designed and developed the recombinant adenoviral vector 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, was conducted by Bharat Biotech.