An intra-nasal vaccine, iNCOVACC, made in India, has received approval for primary and heterologous booster doses for the first time in the world, according to a press release from Bharat Biotech International Limited (BBIL).
According to a press release, “iNCOVACC (BBV154) has received approval from the Central Drugs Standard Control Organization (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above, in India, for heterologous booster doses. BBIL, a global leader in vaccine innovation and developing vaccines for infectious diseases, announced this today.
According to the press report, iNCOVACC is an adenovirus-vectored vaccine with a pre-fusion stabilized SARS-CoV-2 spike protein that is recombinant and replication-deficient. Clinical studies for this vaccine candidate have been conducted in phases I, II, and III with positive outcomes.
Nasal drops can be used to give intranasally using iNCOVACC, which has been specially prepared to do so.
According to the press release, the nasal delivery method was created to be affordable in low- and middle-income nations.
In collaboration with Washington University in St. Louis, which created the recombinant adenoviral vectored construct and tested its effectiveness in preclinical trials, iNCOVACC was created.
Bharat Biotech carried out product development activities related to preclinical safety assessment, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials.
According to the press release, the COVID Suraksha Program of the Department of Biotechnology was partially used by the Government of India to support product development and clinical testing.
“iNCOVACC is an intranasal vaccination for the primary 2-dose schedule and the heterologous booster dosage,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.
“The ability to administer COVID vaccinations nasally is a significant accomplishment for the international scientific community and us. “We continued product development in intranasal vaccines despite the low market for COVID vaccines to ensure that we are well-prepared with platform technologies for future infectious illnesses,” he said.
He also expressed gratitude to Washington University and the Government of India for their support and advice.
We acknowledge the support and advice from the Ministry of Health, CDSCO, Department of Biotechnology, Government of India, Technology Development Board, and Washington University in St. Louis. The administration of iNCOVACC is simple and painless because it has been designed for effective distribution. He added that we have already started the development of COVID variant-specific vaccinations for future preparedness.
The clinical trials, he continued, were carried out to assess the efficacy of iNCOVACC as a primary dosage schedule and as a heterologous booster dose for participants who had already received two doses of the two COVID vaccines that are frequently delivered in India.
“Serum IgGs were measured using ELISAs, and serum neutralizing antibodies were measured using PRNT assays. ELISA measured IgAs in serum and saliva to evaluate the vaccination given by intranasal route. The effectiveness of iNCOVACC at inducing long-term memory T and B cell responses against the ancestral and omicron variants was also assessed, according to Dr. Krishna Ella.
For heterologous booster dosages, iNCOVACC recently got permission under the Restricted Use in Emergency Situation for Ages 18 and Above. In heterologous boosting, a different vaccination was delivered from the one used for the initial dosage series.
Dr. Rajesh S. Gokhale, Secretary of DBT and Chair of BIRAC, praised the scientific community’s efforts as well, noting that DBT “is supporting biotech firms & innovation ecosystem and strategically building Indian bioeconomy.”
According to him, DBT and BIRAC are committed to creating COVID-19 vaccinations that are both reliable and secure as part of Mission COVID Suraksha.
“Our nation should be incredibly proud that the DCGI has approved Bharat Biotech’s intranasal vaccine iNCOVACC (BBV154) for use as a heterologous booster dose against currently available COVID-19 vaccinations. He added that this action would increase vaccine coverage and boost our group’s fight against pandemics.
We are excited by the expansion of the EUA for iNCOVACC as a booster, which enables this intranasal vaccine to be used by a lot more people and hopefully reduces transmission, said Washington University colleague David Curiel, MD, Ph.D., and co-developer of the nasal vaccine technology Michael S. Diamond, MD, Ph.D.
During the ongoing pandemic, he continued, “This approval will extend the alternatives for people to get immunized and protected against the SARS-CoV-2 virus.”
In 2020, Washington University granted Bharat Biotech a license to continue to develop the vaccine technology.
The primary 2-dose regimen for iNCOVACC had previously been approved under Restricted Use in Emergency Situations for Ages 18 and Above. The press stated that 3100 patients participated in phase III studies across 14 trial sites in India to assess safety and immunogenicity.
Studies on the safety and immunogenicity of heterologous booster doses were carried out on 875 participants who received the intranasal BBV154 vaccination after receiving two doses of the two COVID-19 vaccines that are most frequently provided. Nine trial locations were used for the trials throughout India.
According to the press release, iNCOVACCeffect ®’s safety was assessed. The trial’s reactogenic and adverse events were comparable to information from earlier Covid-19 vaccinations that have been reported.
Data on product development will be shared with the public and submitted to peer-reviewed journals.
According to the press announcement, iNCOVACC offers the dual advantages of enabling quicker development of variant-specific vaccines and simple nasal delivery that facilitates mass immunization to guard against developing variations of concern.
It has the potential to be a crucial tool for mass immunization campaigns during pandemics and endemics. Launch dates, prices, and availability will be disclosed in due course following the receipt of this approval.
iNCOVACC is stable at 2–8°C for simple distribution and storage. According to the press release, Bharat Biotech has created significant manufacturing capabilities at numerous locations around India, including Gujarat, Karnataka, Maharashtra, and Telangana.
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