Bharat Biotech applies for market authorisation from DCGI for five arms intranasal heterologous booster

By Shalini Bhardwaj
New Delhi [India], September 11 : Bharat Biotech has applied for market authorisation from the Drugs Controller General of India (DCGI) for intranasal heterologous booster, sources told ANI.
The five arms heterologous Intranasal booster dose means:- "Arm 1: 2 covaxin - booster covaxin, Arm 2: 2 covaxin - booster I/N vaccine, Arm 3: 2 Covishield- booster Covishield, Arm 4: 2 Covishield- booster I/N vaccine, Arm 5: 2 intranasal- booster intranasal," said the source.
The company also sought DCGI nod for phase three study of Intranasal vaccine in the 5-18 age group.
Recently, the Drugs Controller General of India(DCGI) on Tuesday has given emergency use authorization (EUA) to Bharat Biotech for the intranasal vaccine.
"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 under Restricted Use in Emergency Situation for ages 18 and above," said Bharat Biotech in a statement
"iNCOVACC is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated in phase 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," It said further.
"We are proud to announce the approval of iNCOVACC, a global game changer in Intra Nasal vaccines technology and delivery systems. Despite the lack of demand for COVID-19 vaccines, we continued product development in intra-nasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases. We thank the Ministry of Health, the CDSCO, the Dept of Biotechnology Govt of India, and Washington University St. Louis for their support and guidance. iNCOVACC has been designed for efficient distribution and easy administration," said Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech
The intranasal vaccine is a heterologous booster dose, "Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as a heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India," read the statement issued by the company.
"Immunogenicity was evaluated through serum neutralizing antibodies by PRNT assays and serum IgG's through ELISA's. To evaluate vaccines taken through the intranasal route, IgA's were evaluated by ELISA in serum and saliva. The evaluation was also carried out for the ability iNCOVACC to elicit long-term memory T and B cell responses against the ancestral and omicron variants," it said
The vaccine development data will be submitted to peer-reviewed journals, "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 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 regulator approved the vaccine for primary immunisation of those above 18 years, Union Health Minister Dr Mansukh Mandaviya tweeted.
"Big Boost to India's Fight Against COVID-19! Bharat Biotech's ChAd36-SARS-CoV-S covid-19 (Chimpanzee Adenovirus Vectored) recombinant nasal vaccine approved by @CDSCO for primary immunization against COVID-19 in the 18+ age group for restricted use in an emergency situation," Mansukh Mandaviya tweeted.
According to Dr NK Arora, Chairperson COVID-19 working group, the NTAGI Intranasal vaccine will be another feather in India's fight against COVID-19.
He spoke to ANI and said, "Nasal COVID-19 vaccine approved today is first of its kind globally- it is another feather in India's fight against COVID-19. The vaccine uses a novel approach and is likely to influence the transmission of the virus. The vaccine will be available for both primary and booster dose with completion of all regulatory requirements."