Bharat Biotech's intranasal vaccine gets approval for emergency use

The government has given its approval to a nasal vaccine for Covid-19 developed by Bharat Biotech even as the number of cases in the country continued a declining trend.

The nasal vaccine is for “restricted use” among adults “in emergency situation”, said Union Health Minister Dr Mansukh Mandaviya in a tweet, claiming it to be a “Big Boost to India’s Fight Against COVID-19!”

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

The approval has been granted by the Drugs Controller General of India (DCGI) for emergency use in adults and the minister said it will help India defeat Covid-19.

“India has harnessed its science, R&D, and human resources in the fight against COVID-19. This step will further strengthen our collective fight against the pandemic. With the science-driven approach & Sabka Prayas, we will defeat COVID-19,” he said.

Also read: Bharat Biotech’s intranasal vaccine proven safe following trials

Last month, subsequent to finishing the phase III and booster dose trials for its intranasal Covid-19 immunization, Bharat Biotech said it had directed two separate trials for its vaccine, one as an essential portion plan and another as a booster dose, for subjects who have been inoculated with the two usually regulated Covid vaccines in India.

It has proven to be safe, well-tolerated and immunogenic in subjects in controlled trials, BBIL said in a statement.

The data from both Phase III human clinical trials have been submitted for approval to national regulatory authorities, the company said.