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iNCOVACC, Bharat Biotech’s first intranasal Covid vaccine to receive approval

iNCOVACC Covid Vaccine: Bharat Biotech announced that its intranasal Covid-19 vaccine, known as iNCOVACC, had become the first in the world to receive emergency use authorization (EUA) for both primary vaccination and heterologous booster vaccination for those who have already received two doses of another vaccine. For people who are at least 18 years old, both EUAs have been obtained.

iNCOVACC Covid vaccine to receive approval: Key Points

● In order to be prepared for the future, according to Bharat Biotech Chairman and Managing Director Dr. Krishna Ella, the company has also started developing variant-specific vaccines for Covid-19.
● The Hyderabad-based vaccine manufacturer will be announcing the launch dates, pricing, and availability of the vaccine after it has received the necessary licences from the Indian drug regulator.
● Following its integration with the Cowin site, the vaccine is anticipated to be made accessible for administration.
● The company claimed to have huge production facilities developed at numerous locations around India, including Gujarat, Karnataka, Maharashtra, and Telangana.
● The Central Drugs Standard Control Organization (CDSCO) last awarded EUA for the booster after the Indian pharma authority approved iNCOVACC as a primary two-dose vaccine in September of this year.

iNCOVACC Covid vaccine: About

● iNCOVACC is a pre-fusion stabilised SARS-CoV-2 spike protein generated from the Wuhan strain that is included into a recombinant, replication-deficient adenovirus vectored vaccine.
● The intranasal vaccine platform, known as iNCOVACC, according to Bharat Biotech, has the dual advantages of speeding up the development of variant-specific vaccines and enabling easy nasal delivery, which will allow for mass immunisation to protect against emerging variants of concern during pandemics and epidemics.
● The vaccine, which was tested in phase 1 clinical trials, phase 2 clinical trials, and phase 3 clinical trials, has been specifically designed to allow intranasal delivery through nasal drops.
● It was created to be cost-effective in low- and middle-income countries because it can be stored at 2-8°C.

iNCOVACC: About the Clinical trials

● The phase-3 trials for the heterologous booster were carried out on approximately 875 volunteers at 9 trial sites in India, whilst the phase-3 trials for the primary two-dose iNCOVACC vaccine were carried out on approximately 3,100 participants at 14 sites throughout India.
● Its immunogenicity was assessed using ELISAs on serum IgG levels and PRNT tests on serum neutralising antibodies. IgAs were measured by ELISA in serum and saliva to evaluate the vaccination, which is administered intravenously.
● The capacity of iNCOVACC to generate long-term memory T and B cell responses against the ancestral and omicron variants was also assessed.
● The safety impact of iNCOVACC was also assessed, and the trial’s reactogenic events and adverse events were remarkably comparable to published data from other Covid-19 vaccines.
● While Bharat Biotech handled the product development for preclinical safety assessment, large-scale manufacturing scale up, formulation and delivery device development, including human clinical trials, WashU designed and developed the recombinant adenoviral vectored construct and evaluated it for efficacy in preclinical studies.
● The Indian government provided funding for product development and clinical testing via the COVID Suraksha Program of the department of biotechnology.

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