Hyderabad-based Bharat Biotech, announced that their vaccine iNCOVACC (BBV154) had received approval from CDSCO(Central Drugs Standard Control Organization). This can be used only in emergency situations for ages 18 and above.
iNCOVACC, a recombinant adenovirus vaccine with a SARS CoV-2 spike protein, is the world’s first intranasal vaccine to allow delivery of vaccine through nasal drops.
These clinical trials were funded and the product development were initiated by the Government of India, Department of Biotechnology’s, COVID Suraksha Programme. Product related concerns like preclinical safety evaluation, large-scale manufacturing, formulating and delivering device development, including human clinical trials were conducted by Bharat Biotech.
Krishna Ella, Chairman of Bharat Biotech said that iNCOVACC is an intranasal vaccine for the primary 2-dose schedule, and heterologous booster dose. He said that it is a great achievement for them and for the global scientific community to enable nasal administration of COVID vaccines.
The vaccine was evaluated in three phases I,II and III which has been specifically formulated to allow intranasal delivery.
To evaluate iNCOVACC as a primary dose and as heterologous booster dose, scheduled clinical trials were conducted for subjects who had received two doses of the administered COVID vaccines in India. Immunogenicity was evaluated on the basis of serum neutralizing antibodies assessed by PRNT assays and serum IgG through ELISA test. To evaluate the vaccine that was taken through the intranasal route, IgA’s were assessed by ELISA in serum and saliva.
Assessment was also carried out to check the ability of iNCOVACC to invoke the responses against ancestral and omicron variants.
Rajesh Gokhale, Secretary, DBT, said that the approval by DCGI for the vaccine as a heterologous booster dose against currently used COVID-19 vaccine is a great move that will strengthen the collective fight against the pandemic and broaden vaccine coverage.
Dual benefits of iNCOVACC
iNCOVACC has the dual benefit of enabling growth of variant-specific vaccines and easy nasal delivery, enabling mass immunization to protect from further concerns. iNCOVACC promises to become a tool in mass vaccinations in future pandemics. With the receipt of this approval, Bharat Biotech will announce the launch dates, pricing and availability of the vaccine in due course of time.