India’s first intranasal Covid vaccine by Bharat Biotech, iNCOVACC, received the Drugs Controller General of India’s (DCGI) approval on Tuesday for primary immunization against the infection for people above the age of 18 for restricted use in an emergency situation.
Lauding the achivement, Union health minister, Mansukh Mandaviya, said: “The nasal vaccine was a big boost to India’s fight against Covid-19. This is the first nasal Covid-19 vaccine approved in India. India has harnessed its science, R&D and human resources in the fight against Covid-19.”
Two trials were carried out with one as a primary dose schedule and another as a booster dose, for those who had received two shots of Covid-19 vaccines. The company had said it was proven to be safe, well-tolerated and immunogenic in the trials that covered 4,000 subjects.
Krishna Ella, chairman and managing director, Bharat Biotech, said despite the lack of demand for Covid-19 vaccines, they continued product development in intra-nasal vaccines to ensure that the country was well prepared with platform technologies for future infectious diseases.
The ChAd36-SARS-CoV-S Chimpanzee Adenovirus Vectored recombinant nasal vaccine produced local antibodies in the upper respiratory tract which reduced potential infection and transmission. The company completed the phase-III and booster dose trials for its intranasal Covid-19 vaccine on August 22.
Earlier, Suchhitra K Ella, joint managing director, Bharat Biotech, had said while seeking regulatory approvals that the intra-nasal vaccine would make it easier to deploy in mass immunisation campaigns with an easy-to-administer formulation and delivery device. The nasal delivery system was designed and developed to be cost-effective in low and middle-income countries. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern, Ella said.
iNCOVACC, developed in partnership with Washington University St. Louis, had designed and developed the recombinant adenoviral vectored constructs and evaluated them 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 programme.
iNCOVACC is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established manufacturing capabilities in Gujarat, Karnataka, Maharashtra and Telangana for making the vaccine.