First intranasal vaccine for COVID-19 approved: DCGI nod to Bharat Biotech’s intranasal ‘Five Arms’ – Know details

Bharat Biotech Nasal Vaccine: According to sources, the Drugs Controller General of India (DCGI) has approved Bharat Biotech’s intranasal ‘Five Arms’ booster dose for restricted use for Covid19. This is India’s first intranasal vaccine for COVID-19.

The members of the Subject Expert Committee (SEC) of DCGI held a meeting on 15th November to discuss the booster dose – INCOVACC (BBV154).

In September this year, BBIL submitted an application to DCGI seeking market authorization for its ‘Five Arms’ intranasal heterologous booster dose. It has now been announced that iNCOVACC (BBV154) has been approved for restricted use in emergency situations for persons 18 years of age and older.

“We are proud to announce the approval of INCOVACC, a global game changer in intranasal vaccine technology and delivery systems. With continued development we are well prepared. With platform technologies for future infectious diseases. We thank the Ministry of Health, CDSCO, Department of Biotechnology, Government of India, and Washington University St. Louis for their support and guidance iNCOVACC is designed for efficient delivery and easy administration,” Dr. BBIL ​​Chairman and Managing Director Krishna Ella said in a statement according to ANI.

“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 the nose. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries, the BBIL statement said. .

The statement released by the company said, “Clinical trials were conducted to evaluate INCOVACC as a primary dosing schedule as an admixed booster dose for subjects who had previously been treated in India. 2 doses of the two commonly administered Covid vaccines were received.”

“Immunogenicity was assessed by PRNT assays and serum IgG through ELISA to serum neutralizing antibodies. To evaluate vaccines taken through the intranasal route, IgA in serum and saliva was assessed by ELISA .INCOVACC was also evaluated for its ability to elicit term memory T and B cell responses against parental and omicron variants,” it further said.

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Vaccine development data will be submitted to peer-reviewed journals. “iNCOVACC was evaluated to determine its impact on safety. The reactive events and adverse events documented during the trial can be compared to published data from other COVID-19 vaccines. Product development data has been published in peer-reviewed journals will be presented and will be made available in the public domain,” BBIL added in its statement.

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