Union Health Minister Mansukh Mandaviya and Minister of Science and Technology Jitendra Singh launched first-of-it’s-kind intranasal COVID-19 vaccine iNCOVACC manufactured by Hyderabad-based Vaccine developer Bharat Biotech International Limited (BBIL) on January 26, 2023.
The vaccine is expected to be rolled out in private hospitals that have placed advance orders. It is priced at ₹800 a dose in private hospitals. For large volume procurement by the States and the Union government, it is priced at ₹325 a dose.
An Initial manufacturing capacity of several million doses per annum has been established for the vaccine, and this can be scaled up to a billion doses as required, said a BBIL spokesperson.
It is the world’s first Intranasal vaccine for COVID to receive approval for the primary two-dose schedule, and as a heterologous booster dose, administered as nasal drops. This means that those who have previously taken vaccines like Covidshield or Covaxin can take a booster dose of iNCOVACC.
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The BBIL spokesperson further said that Phase-3 trials (as a two-dose regimen) of the vaccine were conducted for safety and immunogenicity in up to 3,100 subjects, in 14 trial sites across India. Also, heterologous booster dose studies were conducted for safety and immunogenicity in up to 875 subjects, with BBV154 intranasal vaccine administered in those previously completing a regimen of the commonly administered COVID vaccines (like Covaxin or Covidsheild). The trials were conducted in nine 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,” BBIL said in a statement.
The intranasal vaccine is stable at 2-8°C. It is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilised spike protein.
The vaccine 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 run by the Indian government has been instrumental in debt financing for commercial scale manufacturing facilities.
The vaccine is cost effective and does not require syringes, needles, alcohol wipes, bandage, etc., thus saving costs related to procurement, distribution, storage and biomedical waste disposal. These are otherwise routinely required for injectable vaccines.
