Nasal vaccine update: The Drugs Controller General of India (DCGI) on January 28, 2022, granted its approval to Bharat Biotech for the trials of its intranasal Covid booster dose in India. The trials of nasal vaccine will be done on 900 candidates.
Earlier, the Subject Expert Committee (SEC) of DCGI had given ‘in-principle’ approval to Bharat Biotech for the phase-III booster dose study for its nasal covid vaccine, a first of its kind in India. The committee had asked Bharat Biotech to submit the protocols for approval 3 weeks ago.
Notably, the Chairman of Bharat Biotech Krishna Ella and co-founder Suchitra Ella have also been honoured with the prestigious Padma Bhushan, announced on January 25, 2022, by the President of India.
Drugs Controller General of India (DCGI) gives permission to BharatBiotech for intranasal booster dose trials. #COVID19 pic.twitter.com/b2NEo5utfQ
— ANI (@ANI) January 28, 2022
Bharat Biotech’s nasal covid booster
Bharat Biotech had submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December 2021 stating that an intranasal vaccine as a booster dose will be easier to administer in the mass vaccination campaigns.
Intranasal covid vaccine in India
Bharat Biotech had received regulatory approval for mid-to-late-stage trials for its intranasal vaccine BBV154 in August 2021.
Bharat Biotech had become the second company to submit an application for the phase-III trials of the third dose in India. Reportedly, the intranasal vaccines have the potential of preventing the transmission of new COVID variants such as Omicron.
Covaxin and Covishield received market approval
The latest development of Bharat Biotech’s nasal booster dose receiving approval for trials in India has come a day after COVAXIN and Covishield received market approval from the Drugs Controller General of India. It means that the vaccines will be available for the adult population in hospitals and clinics.
Read More: COVID-19 vaccine: DCGI grants conditional market approval for Covishield and Covaxin
Booster doses in India
The Government of India in January 2022, in a bid to prevent the COVID-19 infection driven by the Omicron variant, started administering the booster dose of COVID-19 vaccine to healthcare and the healthcare workers as well as the people with co-morbidities who are aged 60 years or above.
COVID-19 vaccines in India
The Government of India gave its approval to COVAXIN, Covishield, Sputnik V for vaccination in the country. Covaxin has been approved for use under the 28-day Multi-Dose Vial Policy from DCGI and WHO Emergency Use Listing (WHO EUL).
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