Bharat Biotech’s intranasal vaccine iNCOVACC gets CDSCO approval for heterologous booster doses

Bharat Biotech International Limited (BBIL), a global vaccine producer, announced on Monday that the Central Drugs Standard Control Organization (CDSCO) in India had approved the use of the heterologous booster doses of the Covid vaccine iNCOVACC (BBV154), which is available as nasal drops.

This vaccine candidate was evaluated in clinical trials at phases I, II, and III, with positive results. The nasal delivery system was created to be cost-effective in low- and middle-income countries. iNCOVACC was created in collaboration with Washington University in St. Louis, which designed and developed the recombinant adenoviral vectored construct and tested its efficacy in preclinical studies.

Bharat Biotech developed products involving preclinical safety assessment, large-scale manufacturing scale up, formulation and delivery device development, as well as human clinical trials. The COVID Suraksha Program of the Department of Biotechnology of the Government of India helped to partially finance product development and clinical trials.

Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech said: “iNCOVACC is an intranasal vaccine for the primary 2-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 intranasal vaccines to ensure that we are well-prepared with platform technologies for future infectious diseases. 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.”

iNCOVACC was tested in clinical trials as a primary dose schedule and as a heterologous booster dose for subjects who had already received two doses of the two Covid vaccines that are frequently used in India.

Plaque Reduction Neutralization Tests (PRNT) and Immunoglobulin G (IgG) assays were used to gauge immunogenicity. In PRNT, a virus is neutralised by a particular antibody, which stops the virus from causing plaques to form in cells. The most prevalent type of antibody, IgG, which guards against bacterial and viral infections, can be found in blood and other bodily fluids. After an infection or vaccination, IgG can take some time to form.

“DBT is fostering biotech enterprises and innovation ecosystems and 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 intranasal vaccine iNCOVACC is a moment of great pride for our country. This move will further strengthen our collective fight against the pandemic and broaden vaccine coverage,” said Dr Rajesh S Gokhale, Secretary, Department of Biotechnology and Chairperson of Biotechnology Industry Research Assistance Council.

In 2020, Washington University licenced vaccine technology to Bharat Biotech for further development.

“We are excited by the expansion of the Emergency Use Authorisation 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,” said Michael S Diamond, of Washington University in St Louis, who co-developed the nasal vaccine technology with Washington University colleague David Curiel.