The Drugs Controller General of India (DCGI) has given approval to intranasal "Five Arms" booster dose for restricted use for COVID-19 patients, it is learnt.
The DCGI has given emergency use authorisation to Bharat Biotech's five arms heterologous booster for people aged 18 years and above, sources told ANI.
Subject expert committee has also held a meeting recently to discuss about Bharat Biotech's five arms intranasal heterologous booster. In the meeting, the SEC recommended this vaccine for Covid19 for the age above 18yrs.
Bharat Biotech applied in September for DCGI approval for market authorisation of "Five Arms" intranasal heterologous booster dose.
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", an official explained.
Earlier, DCGI gave emergency use authorization (EUA) to bharat Biotech for 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." Bharat Biotech said 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 intranasal vaccines technology and delivery systems. Despite the lack of demand for COVID-19 vaccines, we continued product development in intranasal vaccines to ensure that we are well prepared with platform technologies for future infectious diseases. We thank the Ministry of Health, the CDSCO, Dept of Biotechnology Government of India, and Washington University St. Louis for their support and guidance. iNCOVACC has been designed for efficient distribution and easy administration." Bharat Biotech Chairman and Managing Director Dr. Krishna Ella said.
The intranasal vaccine is a heterologous booster dose, "Clinical trials were conducted to evaluate iNCOVACC as a primary dose schedule, as heterologous booster dose for subjects who have previously received 2 doses of the two commonly administered covid vaccines in India." the statement added.
"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. Evaluation was also carried out for ability iNCOVACC to elicit long term memory T and B cell responses against the ancestral and omicron variants", it added.
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", it further said.
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.
( With inputs from ANI )
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