Bharat Biotech’s iNCOVACC receives primary series and heterologous booster approval

Bharat Biotech’s iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organisation (CDSCO) under restricted use in emergency situation for people aged 18 years and above, in India, for heterologous booster doses, a company statement said.

According to the statement, iNCOVACC is a recombinant replication-deficient adenovirus-vectored vaccine with a pre-fusion stabilised SARS-CoV-2 spike protein. This vaccine candidate was evaluated in phases I, II and III clinical trials with successful results. iNCOVACC has been specifically formulated to allow intra-nasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in Low- and Middle-Income Countries (LMICs).

Further, the statement informed that iNCOVACC was developed in partnership with the Washington University, St Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated in pre-clinical studies for efficacy. Product development related to pre-clinical 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.

Clinical trials 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 vaccines in India, the statement added.

Krishna Ella, Chairman and Managing Director, Bharat Biotech, said in the statement, “iNCOVACC is an intra-nasal vaccine for the primary two-dose schedule and heterologous booster dose. This is a great achievement for us and the global scientific community to enable nasal administration of COVID vaccines. Despite the lack of demand for COVID vaccines, we continued product development in intra-nasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases. We thank the Ministry of Health, CDSCO, Department of Biotechnology, Government of India, Technology Development Board and Washington University, St. Louis, for their support and guidance. iNCOVACC has been designed for efficient distribution, easy and pain-free administration. We have also initiated development of variant-specific vaccines for COVID for future preparedness.”

The statement also informed that the vaccine’s immunogenicity was evaluated through serum-neutralising antibodies by PRNT assays and serum IgG’s through ELISA’s. To evaluate vaccine, taken through the intra-nasal route, IgA’s were evaluated by ELISA in serum and saliva. Evaluation was also carried out for ability iNCOVACC to elicit long-term memory T and B cell responses against the ancestral and omicron variants.

Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC, said in the statement, “DBT is fostering biotech enterprises and innovation ecosystem and strategically strengthening Indian bioeconomy. DBT, along with BIRAC, is dedicated to the development of effective and safe COVID-19 vaccines under Mission COVID Suraksha. The DCGI’s approval of Bharat Biotech’s intra-nasal vaccine iNCOVACC (BBV154) to be used as a heterologous booster dose against currently available COVID-19 vaccines is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage.”

Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development, according to the statement.

“We are excited by the expansion of the EUA for iNCOVACC as a booster, which enables this intra-nasal vaccine to be used by many more people, and hopefully curtail transmission,” said Michael S Diamond, MD, PhD, Washington University, St Louis, who co-developed the nasal vaccine technology with Washington University colleague David Curiel, MD, PhD.

iNCOVACC was evaluated to determine its impact on safety. The reactogenic events and adverse events that were documented during the trial were comparable to the published data from other COVID-19 vaccines. Product development data will be submitted to peer-reviewed journals and will be made available in the public domain, the statement concluded.