iNCOVACC first intranasal Covid vax in world to bag nod for primary, heterologous booster: Bharat Biotech | India News

HYDERABAD: Bharat Biotech on Monday said its iNCOVACC has become the world’s first intranasal Covid-19 vaccine to receive emergency use authorisation (EUA) as a primary vaccine as well as heterologous booster for those who have received two doses of another vaccine. Both the EUAs have been granted for those aged 18 years and above.
iNCOVACC is a recombinant replication deficient adenovirus vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein derived from the Wuhan strain.
Bharat Biotech chairman & managing director Dr Krishna Ella, said the company has also initiated development of variant-specific vaccines for Covid-19 for future preparedness.
“Despite the lack of demand for Covid-19 vaccines, we continued product development in intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases,” he said.
The Hyderabad-based vaccine maker said with the approvals from the Indian drug regulator now in place, it will be announcing the launch dates, pricing and availability of the vaccine in due course of time. The vaccine is expected to become available for administration post its integration with the Cowin portal.
Bharat Biotech said the intranasal vaccine platform — iNCOVACC – offers the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery will enable mass immunisation to protect from emerging variants of concern during pandemics and epidemics.
The vaccine, which was evaluated in phase-1,2 and 3 clinical trials, has been specifically formulated to allow intranasal delivery through nasal drops and has been designed and developed to be cost-effective in low- and middle-income countries as it can be stored at 2-8°C, the company added.
The company said it has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.
After the Indian drug regulator granted EUA for iNCOVACC as a primary two-dose vaccine in September this year, the Central Drugs Standard Control Organisation (CDSCO) on Friday last granted EUA for the booster.
While the phase-3 trials to test the safety and immunogenicity of iNCOVACC as a primary two-dose vaccine were conducted on around 3,100 volunteers at 14 sites across India, that for the heterologous booster were conducted on around 875 volunteers at 9 trial sites across India.
Its immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG’s through ELISA’s. To evaluate the vaccine, which is taken through the intranasal route, IgA’s were evaluated by ELISA in serum and saliva. Evaluation was also carried out for the ability of iNCOVACC to elicit long-term memory T and B cell responses against the ancestral and omicron variants.
iNCOVACC was also evaluated to determine its impact on safety and the reactogenic events and adverse events that were documented during the trial were highly comparable to published data from other Covid-19 vaccines, Bharat Biotech said.
“The product development data will be submitted to peer reviewed journals and will be made available in the public domain,” said Bharat Biotech which developed the vaccine in partnership with Washington University, St Louis.
While WashU designed and developed the recombinant adenoviral vectored construct and evaluated it in preclinical studies for efficacy, the 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.
Product development and clinical trials were funded in part by the Government of India, through the department of biotechnology’s COVID Suraksha Programme.

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