Bharat Biotech's nasal COVID vaccine gets DCGI nod

Hyderabad-based Bharat Biotech International Limited (BBIL) today announced that its intranasal COVID19 vaccine iNCOVACC (BBV154), has got formal approval from the Drug Controller General of India (DCGI).

This is the second Bharat Biotech coronavirus vaccine to get the nod after Covaxin.

“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,” Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, said.

Also Read | Explainer: Intranasal vaccine against COVID-19 and why it is awaited so eagerly

The pharma company said 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,” company said in a statement.

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_INDIA_INF for primary immunization against COVID-19 in 18+ age group for restricted use in emergency situation.

— Dr Mansukh Mandaviya (@mansukhmandviya) September 6, 2022

Also Read | All about the world's first inhalable COVID-19 vaccine to get approval

Bharat Biotech said iNCOVACC was developed in partnership with Washington University St. Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.

"The 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 company said.

According to the Covaxin makers, iNCOVACC has the double benefit of enabling faster development of variant specific vaccines and easy nasal delivery that enables mass immunization to protect from emerging variants of concern.

"It promises to become an important tool in mass vaccinations during pandemics and endemics. With the receipt of approval today, the product will be launched and available for use in due course of time," Bharat Biotech said.

According to Bharat Biotech, the nasal vaccine iNCOVACC is stable at 2-8°C for easy storage and distribution.

The company has claimed that it has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana with operations pan India.

Also Read | World’s first Covid vaccine you inhale is approved in China

Benefits of COVID-19 nasal vaccine

Any injectable vaccine only protects the lower level (of the body) that was why people who were vaccinated with injectable vaccines may still get RT-PCR positive, whereas the nasal vaccine gives protection to the whole body, news agency PTI quoted Bharat Biotech chairman Krishna Ella as saying.

The firm completed clinical trials of the nasal vaccine with about 4,000 volunteers, Ella said. He said there was no instance of side effects. "Intranasal vaccine stimulates a broad immune response," the company has claimed.

Other benefits: As mentioned by Bharat Biotech, the nasal vaccine is:

• Likely to block both infection and transmission of COVID-19
• Non-invasive and needle-free
• Easy to administer as it does not require trained healthcare workers
• Eliminates needle-associated risks (injuries and infections)
• High compliance — ideally suits children and adults
• Scalable manufacturing — able to meet global demand