India’s first intranasal Covid-19 vaccine! DCGI clears Bharat Biotech’s product for use in adults

The Drugs Controller General of India (DCGI) on Tuesday cleared Bharat Biotech’s intranasal Covid-19 vaccine for use as primary immunisation against the infection for patients above the age of 18, Union Health Minister Mansukh Mandaviya said. The ChAd36-SARS-CoV-S COVID-19 (Chimpanzee Adenovirus Vectored) is India’s first nasal vaccine against Covid-19. The minister added that the vaccine will have “restricted use” among adults “in emergency situation”. 

Terming it as a big boost to India’s Covid-19 fight, the health minister said that the step will further strengthen India’s collective fight against the pandemic. “India has harnessed its science, research and development, and human resources… under PM Narendra Modi’s leadership.” 

The Hyderabad-based firm completed its clinical trials of the new nasal vaccine with about 4,000 volunteers and reported that there were no side effects or adverse effects after the trial.

In August, Bharat Biotech said it had completed two separate trials for its intranasal Covid vaccine in two different schedules — as a primary dose schedule and another as a booster dose — on recipients who have got both doses of the commonly available vaccines in India.  

The company in a statement said that the nasal vaccine has been found to be safe, well-tolerated, and immunogenic in subjects in controlled trials. The data of the Phase III trials were submitted to the national regulatory authorities for approval. 
As per government data updated on Tuesday, India saw a single-day rise of 4,417 Covid infections, which is the lowest in three months. 

(With agency inputs)

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