Bharat Biotech's intranasal Covid-19 vaccine approved for restricted use

In a boost to India's vaccine programme, Hyderabad-based Bharat Biotech International Limited (BBIL) has received an emergency use authorisation for its intranasal Covid-19 vaccine on people above the age of 18, from the Drugs Controller General of India (DGCI). This is India's first nasal vaccine against Covid.

Sharing the news, Union health minister Dr Mansukh Mandaviya terms it a "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 immunisation against COVID-19 in 18+ age group for restricted use in an emergency situation," he tweets.

The minister also says that this will further strengthen the country's collective fight against the pandemic. "India has harnessed its science, R&D, and human resources in the fight against COVID-19 under PM @NarendraModi Ji's leadership. With the science-driven approach & Sabka Prayas, we will defeat COVID-19," he adds.

As per Bharat Biotech, BBV154 (intranasal vaccine) has proven to be safe, well-tolerated, and immunogenic during phase I and II clinical trials. A recombinant replication-deficient adenovirus vectored vaccine, with a pre-fusion, stabilised spike protein, this intranasal vaccine was developed in partnership with Washington University St Louis.

Two separate and simultaneous clinical trials were conducted to evaluate BBV154 as a primary dose (2-dose) schedule and a heterologous booster dose for subjects who have previously received two doses of the two commonly administered covid vaccines in India. The vaccine remains stable at 2-8 degree Celsius and can be easily stored and distributed.

BBV154 has the double benefit of enabling faster development of variant-specific vaccines and easy nasal delivery, which helps mass immunisation protect from emerging concern variants. Plus, the company says the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries.

The government also partly funded product development and clinical trials of the vaccine intranasal vaccine through the Department of Biotechnology’s, COVID Suraksha programme.

Why intranasal vaccine is crucial

An intranasal vaccine stimulates a broad immune response. The nasal route has excellent potential for vaccination due to the organised immune systems of the nasal mucosa. It's non-invasive and needle-free. It ensures ease of administration – does not require trained healthcare workers. It also eliminates needle-associated risks (injuries and infections).

Suchitra K. Ella, joint managing director, Bharat Biotech, had earlier said that if approved, the intranasal vaccine will make it easier to deploy in mass immunisation campaigns, with an easy-to-administer formulation and delivery device. "Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern."

Bharat Biotech's whole inactivated virus-based Covid-19 vaccine, COVAXIN, received the World Health Organisation (WHO) approval for emergency use listing in November 2021. The vaccine was the first indigenous COVID-19 vaccine developed by an Indian pharma company. In October 2021, Covaxin also received approval for usage on children between 2 and 18 years of age.