According to officials, the Drugs Controller General of India (DCGI) granted Bharat Biotech an emergency use authorisation (EUA) for the intranasal vaccine iNCOVACC.
Bharat Biotech’s needle-free intranasal vaccination for COVID-19 is the first of its type. “Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that intranasal COVID vaccine (BBV154) has received approval under Restricted Use in Emergency Situation for ages 18 and above,” the company said in a statement.
The iNCOVACC is a vaccine vectored with a recombinant replication-deficient adenovirus and a pre-fusion stabilised spike protein. This vaccine candidate was successfully tested in phase I, II, and III clinical trials.
This vaccination has been particularly designed for intranasal administration through nasal drops. The nasal delivery method was created to be cost-effective in poor and middle-income nations.
The clearance, according to Bharat Biotech’s chairman, is a source of pride for the company, and the intra-nasal vaccination will be a worldwide game changer.
“Despite the absence of demand for COVID-19 vaccines, we kept developing intra-nasal vaccines to guarantee that we are well equipped with platform technologies for future infectious illnesses.” “We are grateful to the Ministry of Health, the CDSCO, the Government of India’s Department of Biotechnology, and Washington University in St. Louis for their assistance and advice,” stated Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech.
The intranasal vaccination is a differentiating booster dosage.
“Clinical studies were done to test iNCOVACC as a primary dosage schedule and as a heterologous booster dose for participants who had previously received two doses of the two routinely given covid vaccines in India,” according to the announcement.
“Immunogenicity was assessed using PRNT tests for serum neutralising antibodies and ELISAs for serum IgG. IgA levels in blood and saliva were measured using ELISA to assess vaccinations administered intranasally. The capacity of iNCOVACC to generate long-term memory T and B cell responses against the ancestral and omicron variants was also assessed “it was added
The data gathered during vaccine development will be published to peer-reviewed publications.
“The influence of iNCOVACC on safety was assessed. The reactogenic and adverse events seen throughout the experiment were extremely comparable to previously reported data from other covid-19 vaccinations. Product development data will be published to peer-reviewed publications and made publicly available.”
The iNCOVACC is stable at 2-8°C, making it ideal for storage and distribution. Bharat Biotech has created major manufacturing capacities in India, including Gujarat, Karnataka, Maharashtra, and Telangana, with activities across the country.
Dr. Mansukh Mandaviya, Union Health Minister, has authorised the vaccine for primary immunisation of those over the age of 18.
“A Significant Advance in India’s Fight Against COVID-19!” Mansukh Mandaviya tweeted, “@CDSCO has authorised Bharat Biotech’s ChAd36-SARS-CoV-S covid-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine for primary vaccination against COVID-19 in the 18-plus age range for limited use in an emergency case.”
The NTAGI intranasal vaccine, according to Dr. NK Arora, Chairperson of the Covid-19 working committee, would be another feather in India’s cap in the fight against Covid-19.
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“The nasal Covid-19 vaccination authorised today is the first of its type in the world, and it is another feather in India’s cap in the fight against Covid-19. The vaccination takes a unique strategy and is expected to alter viral propagation. With the completion of all regulatory criteria, the vaccine will be ready for both primary and booster doses “Dr. NK Arora said.