iNDICA NEWS BUREAU-
On January 26 when India celebrates its Republic Day, Bharat Biotech plans to launch its intranasal Covid-19 vaccine iNCOVACC. Executive chairman of the company, Dr. Krishna Ella[Above photo], announced before a gathering on Saturday, January 21, that the vaccine manufacturer had already received approval from the Central Drugs Standard Control Organisation (CDSCO) earlier this month for the nasal vaccine, the first of its kind in India.
“Our nasal vaccine will be officially launched on Republic Day on January 26,” said Ella while participating in a session during the 8th edition of the India International Science Festival (IISF) at the Maulana Azad National Institute of Technology (MANIT) in Bhopal, Madhya Pradesh, on Saturday. Ella made the announcement while speaking at a session titled ‘Face-to-Face with New Frontiers in Science’.
The CDSCO has approved a primary two-dose schedule and a heterologous booster dosage for iNCOVACC. After the CDSCO approved the nasal vaccination in December 2022, the National Technical Advisory Group on Immunization in India suggested adding the vaccine to the list of “precautionary doses” that adults can take as boosters.
The vaccine was created in collaboration with Washington University in St Louis, which created the recombinant adenoviral vector construct and tested its effectiveness in preclinical tests. Phase-III trials were conducted for safety, and immunogenicity on 3100 subjects, in 14 trial sites across India. Heterologous booster dose studies were given for safety and immunogenicity to 875 test subjects, where a booster dose of intranasal vaccine was administered to study participants who were previously vaccinated with licensed COVID vaccines. The clinical trials were conducted in 9 trial sites across India.
The National Institute of Immunology (NII), an autonomous institute of DBT in New Delhi utilized its “Human Immune Monitoring and T-cell Immunoassay Platform” to examine the systemic and mucosal cellular immune responses of the trial participants.
“This vaccine 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. It promises to become an important tool in mass vaccinations during pandemics and endemics,” the Ministry of Science And Technology said in a statement.
The nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries. This vaccine is stable at 2-8°C for easy storage and distribution. Large manufacturing capabilities have been established by Bharat Biotech at multiple sites across India, including Gujarat, Karnataka, Maharashtra, and Telangana, with operations pan India.
Bharat Biotech had earlier announced that the cost of iNCOVACC will be Rs. 325 per dose for bulk purchases by the federal and state governments and Rs. 800 per dose for commercial vaccination clinics. The vaccine will be administered as a booster shot to everyone above the age of 18. Two doses will be given, separated by 28 days.
As per the vaccine manufacturer, the nasal route has excellent potential for vaccination due to the organized immune system of the nasal mucosa. Thus, intranasal immunization of ChAd-SARS-CoV-2-S can create an immune response in the nose, which is the point of entry for the virus, which will protect against disease, infection, and transmission.