Hyderabad, Dec 27, 2022: Bharat Biotech iNCOVACC® (BBV154),the nasal vaccine for covid-19 is scheduled to be introduced in the country as a booster dose shortly. iNCOVACC® is now available on CoWin, and priced at INR 800 for private markets and priced at INR 325 for supplies to Govt of India and State Governments. The price is exclusive of GST.
Earlier this month, Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for the use of heterologous booster doses of iNCOVACC®.
Updated Key Facts about Bharat Biotech iNCOVACC Nasal Vaccine for Covid-19
- Bharat Biotech iNCOVACC® will be rolled out in the fourth week of January
- iNCOVACC® to be rolled out as booster dose for those above 18 years of age.
- iNCOVACC® to be priced at INR 325 / dose for large volume procurement by State Governments and Govt of India.
- iNCOVACC® is the world’s first Intranasal vaccine for COVID to receive approval for the primary 2-dose schedule, and as a heterologous booster dose.
- Phase III trials (as a 2-dose regimen) were conducted for safety, immunogenicity in ~3100 subjects, in 14 trial sites across India.
- Heterologous booster dose studies were conducted for safety and immunogenicity in ~875 subjects, with BBV154 intranasal vaccine administered in those previously completing a regimen of the commonly administered COVID vaccines. The trials were conducted in 9 trial sites across India.
- iNCOVACC® recipients demonstrated significant levels of Mucosal IgA antibody levels (measured in the saliva). Mucosal IgA antibodies in the upper respiratory tract may provide benefit in reducing infections and transmission.
Bharat Biotech iNCOVACC® is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion-stabilized SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC® 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.
Dr. Krishna Ella, Executive Chairman said; “We have achieved the goals we set for ourselves during this pandemic. We have developed COVAXIN® and iNCOVACC®, two COVID vaccines from two different platforms, with two different delivery systems. The vectored intranasal delivery platform gives us the capability for rapid product development, scale-up, easy and painless immunization during public health emergencies and pandemics. We thank the Ministry of Health, CDSCO, Dept of Biotechnology, Govt of India, Technology Development Board, and Washington University, St Louis, for their support and guidance.”
As a needle-less vaccination, Bharat Biotech’s iNCOVACC® will be India’s first such booster dose. India will now have more options when it comes to third doses or precautionary doses. iNCOVACC®’s manufacturing platform has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern.
Clinical trials 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 vaccines in India.
Bharat Biotech 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. Product development and clinical trials were funded in part by the Government of India, through the Department of Biotechnology’s, COVID Suraksha Program.
Despite the lack of demand for COVID vaccines, Bharat Biotech continued product development in intranasal vaccines, to be well-prepared with platform technologies for future infectious diseases. iNCOVACC® has been designed for efficient distribution and easy pain free administration. Bharat Biotech has also initiated development of variant-specific vaccines for COVID in an attempt be future ready.
iNCOVACC® is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.