According to the press release, iNCOVACC® was launched by Dr. Mansukh Mandaviya, Hon’ble Minister for Health and Family Welfare, in the presence of Dr. Jitendra Singh, Hon’ble Minister for Science & Technology, on the occasion of Republic Day.
Bharat Biotech launches iNCOVACC®: World’s 1st intranasal COVID vaccine for Primary series and Heterologous booster#Bharatbiotech #nasalvaccine #incovacc #incovacclaunch #covidvaccine #covid19 #boosterdose #intranasalvaccine #heterollogousbooster #worldsfirstvaccine pic.twitter.com/SGszgbbSAQ— Bharat Biotech (@BharatBiotech) January 26, 2023
Product development and clinical trials for iNCOVACC® were funded in part by the Government of India, through the Department of Biotechnology’s, COVID Suraksha Program.
Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for iNCOVACC® to be administered for primary series and as heterologous booster doses. Amid growing COVID19 cases and emerging variants of the highly transmissible virus, a booster dose of the vaccine becomes imperative. iNCOVACC® is now available on CoWIN, and priced at INR 800 for private markets and INR 325 for supplies to Govt of India and State Governments.
iNCOVACC® is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase I, II and III clinical trials with successful results.
This vaccine 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. As a needleless vaccination, Bharat Biotech's iNCOVACC® will be the world's first such booster dose. India will now have more options when it comes to third doses or precautionary doses.
Clinical trials and extensive humoral and cell mediated responses were conducted to evaluate iNCOVACC® as a primary dose schedule, and as heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID-19 vaccines in India. 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.
iNCOVACC® 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, Govt of India, has been instrumental in debt financing for commercial scale manufacturing facilities.
Despite the lack of demand for COVID-19 vaccines, Bharat Biotech continued product development in intranasal vaccines, to be well-prepared with platform technologies for future infectious diseases. Bharat Biotech has also initiated development of variant-specific vaccines for COVID in an attempt to be future ready.
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