The country got its first intranasal and the world's first made-in-India intranasal vaccine iNCOVACC on the occasion of Republic Day after the Hyderabad-based Bharat Biotech received approval for the primary two-dose schedule and as a heterologous booster dose. The vaccine, launched by health minister Mansukh Mandaviya and science and technology minister Jitendra Singh, is being dubbed as a "game changer" by experts.
Bharat Biotech's needle-free intranasal vaccine was approved by India's drug regulator after successful evaluation in phase I, II and III clinical trials for ages 18 and above in November 2022. iNCOVACC is also the world's first intra-nasal Covid-19 shot that has been approved as both a primary series and heterologous booster. The vaccine has been designed for efficient distribution and easy and pain-free administration.
Bharat Biotech, in a statement on January 26, said amid growing COVID-19 cases and emerging variants of the highly transmissible virus, a booster dose of the vaccine becomes imperative. iNCOVACC is available on the government's CoWIN platform and is priced at ₹800 for private markets and ₹325 for supplies to the government and state governments.
Terming it a "mighty display" of India's research and innovation prowess, the health minister said: "This is a historic achievement & a testimony to the innovative zeal of our scientists. It has made every Indian proud. Heartiest congratulations to all our hardworking scientists and innovators who are working relentlessly to fulfil the dream of an Aatmanirbhar Bharat."
He said India contributes 65% of the vaccine need of the world, saving the lives of children, adolescents and adults. "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.”
Union minister Jitendra Singh said India has taken the lead in vaccine innovation. "iNCOVACC nasal vaccine launched today will be a huge success, with Bharat Biotech's expertise.”
The intranasal vaccine iNCOVACC allows intranasal delivery through nasal drops, which is aimed to be cost-effective in low and middle-income countries. 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.
iNCOVACC has been 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. Bharat Biotech had done preclinical safety evaluation, large-scale manufacturing scale-up, formulation and delivery device development, including human clinical trials. The government's Technology Development Board debt financed commercial-scale manufacturing facilities with regard to the vaccine.
Bharat Biotech says despite the lack of demand for COVID-19 vaccines, it continued product development in intranasal vaccines so India could 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."