HQ Team
January 1, 2023: Bharat Biotech, an Indian developer of vaccines for infectious diseases, will roll out its nasal Covid-19 vaccine for patients above 18 years in the fourth week of this month.
iNCOVACC will be a booster dose priced at INR 800 ($9.67) for private hospitals and INR 325 for government healthcare institutions, according to a statement.
The nasal vaccine is the “world’s first Intranasal vaccine for COVID to receive approval for the primary 2-dose schedule, and as a heterologous booster dose.”
The vaccine was formulated to allow intranasal delivery through nasal drops and has been designed and developed to be cost-effective in low- and middle-income countries.
Regulator’s approval
In December last year, Bharat Biotech received approval from the Central Drugs Standard Control Organization, the drug regulator, for using heterologous booster doses of iNCOVACC.
The vaccine candidate got evaluated in three phases of clinical trials with successful results, according to the company statement.
Phase III trials, in two doses, were conducted for safety, and immunogenicity in more than 3100 subjects, in 14 trial sites across India.
Heterologous booster dose studies were conducted for safety and immunogenicity in more than 875 subjects, with a BBV154 intranasal vaccine administered in those previously completing a regimen of the commonly administered Covid vaccines. The trials were conducted in nine trial sites across India.
Mucosal antibodies
iNCOVACC recipients demonstrated significant levels of Mucosal IgA antibody levels, which are measured from the saliva. Mucosal IgA antibodies in the upper respiratory tract may provide benefits in reducing infections and transmission, according to the statement.
“We have developed COVAXIN® and iNCOVACC®, two COVID vaccines from two different platforms, with two different delivery systems,” said Dr Krishna Ella, executive chairman.
“The vectored intranasal delivery platform gives us the capability for rapid product development, scale-up, easy and painless immunisation during public health emergencies and pandemics.”
iNCOVACC’s manufacturing platform has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that helps mass immunisation to protect from emerging variants of concern, he said.
The company developed the vaccine in partnership with Washington University, St. Louis,. 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.
Government funds
The development of the product and clinical trials were partly funded 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 of intranasal vaccines to be well-prepared with platform technologies for future infectious diseases, according to the statement.
The vaccine is stable at 2-8 degree centigrade for easy storage and distribution.
With 145 global patents, Bharat Biotech has manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana.
The company, located in India’s southern Genome Valley in Hyderabad, has a portfolio of more than 19 vaccines, four bio-therapeutics, registrations in more than 125 countries, and the World Health Organization.
