Bharat Biotech’s intranasal covid vaccine priced at ₹325 for govt hospitals

Bharat Biotech’s intranasal vaccine was approved by the Union health ministry as a booster dose for those aged 18 years and above.

According to the company, iNCOVACC is the world’s first intranasal vaccine for covid-19 to have received approval for a primary two-dose schedule, and as a heterologous booster dose.

Clinical trials were conducted to evaluate iNCOVACC as a primary dose, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered Covid-19 vaccines in India.

The phase III trials as a two-dose regimen for safety, immunogenicity were conducted in around 3,100 subjects, in 14 trial sites across India. Heterologous booster dose studies were conducted in around 875 subjects who had previously completed a regimen of commonly administered COVID vaccines. These trials were conducted in nine trial sites across India.

As per Bharat Biotech, 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.”

“We have achieved the goals we set for ourselves during this pandemic. We have developed COVAXIN and iNCOVACC, two covid-19 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,” said Dr Krishna Ella, executive chairman, Bharat Boitech.

As a needle-less vaccine, 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.

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. The nasal spray 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.

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. However, product development and clinical trials were funded Department of Biotechnology.

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.