India-made iNCOVACC, world's first intra-nasal vaccine to receive approval for both primary series, Heterologous booster

Hyderabad (Telangana) [India], November 28 : iNCOVACC, on Tuesday, became the world's first intra-nasal vaccine to receive both Primary series and Heterologous booster approval, Bharat Biotech International Limited (BBIL) announced in a press release.
"Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that iNCOVACC (BBV154), has received approval from the Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for ages 18 and above, in India, for heterologous booster doses," the release stated.
As per the release, iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized 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 intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, the release stated.
iNCOVACC was developed in partnership with Washington University, St. Louis, which had designed and developed the recombinant adenoviral vectored construct and evaluated it 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. Product development and clinical trials were funded in part by the Government of India, through the Department of Biotechnology's, COVID Suraksha Program, the release stated.
Chairman & Managing Director, Bharat Biotech, Dr Krishna Ella, said "iNCOVACC is an intranasal vaccine for the primary 2-dose schedule, and the 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 intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases," he said.
He also thanked the Government of India and Washington University for their support and guidance.
"We thank the Ministry of Health, CDSCO, Dept of Biotechnology, Govt of India, Technology Development Board, and Washington University, St. Louis, for their support and guidance. iNCOVACC has been designed for efficient distribution and easy and pain-free administration. We have also initiated the development of variant-specific vaccines for COVID for future preparedness," he said.
He added that the clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, and as a heterologous booster dose for subjects who have previously received two doses of the two commonly administered COVID vaccines in India.
"Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG's through ELISA's. To evaluate the vaccine, taken through the intranasal route, IgA's were evaluated by ELISA in serum and saliva. The 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," Dr Krishna Ella further said.
iNCOVACC recently received approval under Restricted Use in Emergency Situation for ages 18 and above for heterologous booster doses
In heterologous boosting, a person administered a different vaccine from the one that was used for the primary dose series.
Secretary, DBT, and Chairperson, BIRAC, Dr Rajesh S. Gokhale also lauded the efforts of the scientific community saying "DBT is fostering biotech enterprises & innovation ecosystem and strategically strengthening Indian bioeconomy.
He said that 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 intranasal 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," he further said.
Michael S. Diamond, MD, PhD, of Washington University in St. Louis, who co-developed the nasal vaccine technology with Washington University colleague David Curiel, MD, PhD said "We are excited by the expansion of the EUA for iNCOVACC as a booster, which enables this intranasal vaccine to be used by many more people, and hopefully curtail transmission,"
"This approval will increase the options for people to get vaccinated and protected against the SARS-CoV-2 virus during the ongoing pandemic," he added.
Washington University licensed the vaccine technology to Bharat Biotech in 2020 for further development.
iNCOVACC had earlier received approval under Restricted Use in Emergency Situation for ages 18 and above for the primary 2-dose schedule. Phase III trials were conducted for safety, and immunogenicity in 3100 subjects, at 14 trial sites across India., the release said.
Heterologous booster dose studies were conducted for safety and immunogenicity in 875 subjects, with BBV154 intranasal vaccine administered post 2 doses of the two commonly administered COVID-19 vaccines. The trials were conducted at 9 trial sites across India.
As per the release, iNCOVACC® was evaluated to determine its impact on safety. The reactogenic events and adverse events that were documented during the trial were highly comparable to 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.
iNCOVACC has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern, the release stated.
It promises to become an important tool in mass vaccinations during pandemics and endemics. With the receipt of this approval, launch dates, pricing and availability will be announced in due course of time.
iNCOVACC is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India, the release further stated.