Bharat Biotech announced on Monday that its Covid vaccine iNCOVACC in the form of nasal drops has been approved by the CDSCO
Published Date – Mon 28 Nov 22 06:54 PM
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Hyderabad: Hyderabad-based global vaccine manufacturer Bharat Biotech International Limited (BBIL) announced on Monday that its Covid vaccine iNCOVACC (BBV154) in the form of nasal drops has been approved by the Central Drugs Standard Control Organization (CDSCO) for restricted use in India18 Allogeneic booster doses for emergencies aged 10 and over.
The vaccine candidate was evaluated in phase I, II and III clinical trials with successful results. The design and development of nasal drug delivery systems is cost-effective in low- and middle-income countries. iNCOVACC was developed in collaboration with Washington University in St. Louis, which designed and developed the recombinant adenoviral vector construct and evaluated efficacy in preclinical studies.
Bharat Biotech performed product development related to preclinical safety assessments, large-scale manufacturing scale-up, formulation and delivery device development including human clinical trials. Product development and clinical trials are partially funded by the Government of India through the Ministry of Biotechnology’s COVID Suraksha scheme.
“iNCOVACC is an intranasal vaccine for the main 2-dose schedule and a heterologous booster dose. This is a great achievement for us and the global scientific community to enable intranasal administration of a Covid vaccine. Despite insufficient demand, we continue product development for intranasal vaccines to ensure we are fully prepared with our platform technology for future infectious diseases.
iNCOVACC is designed for efficient dispensing, easy and painless administration. We have also initiated the development of a variant-specific vaccine against Covid for future use,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
A clinical trial was conducted to evaluate iNCOVACC as a primary dosing regimen and as an allogeneic booster dose in subjects who had previously received two doses of two commonly used Covid vaccines in India.
Immunogenicity was assessed by plaque reduction neutralization test (PRNT) and immunoglobulin G (IgG) assay. PRNT exploits the ability of specific antibodies to neutralize the virus, which in turn prevents the virus from forming plaques in cells. IgG is the most common antibody in blood and other body fluids that protects against bacterial and viral infections. IgG may take some time to form after infection or immunization.
“DBT is nurturing biotech businesses and innovation ecosystem and strengthening India’s bioeconomy. Together with BIRAC, DBT is working towards developing an effective and safe Covid-19 vaccine under Mission Covid Suraksha. DCGI approves Bharat Biotech’s intranasal vaccine iNCOVACC is A moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and expand vaccine coverage,” said Dr Rajesh S Gokhale, Minister of Biotechnology and Chairman of the Biotechnology Industry Research Assistance Council.
“We are pleased to expand iNCOVACC’s Emergency Use Authorization as a booster, which will allow this intranasal vaccine to be used by more people and hopefully reduce transmission. This approval will increase people’s access to vaccination and prevention during the ongoing pandemic.” SARS-CoV-2 virus of choice,” said Michael S Diamond of Washington University in St. Louis, who co-developed the nasal vaccine with technical colleague David Currier.
The University of Washington licensed the vaccine technology to Bharat Biotech in 2020 for further development. iNCOVACC is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities in various locations in India including Gujarat, Karnataka, Maharashtra and Telangana, with operations across India.
