Bharat Biotech receives approval to test nasal COVID-19 shot as booster

pharmafile | January 5, 2022 | News story | Research and Development  

India’s drug regulator has granted approval to Bharat Biotech, for late stage trials of its nasal COVID-19 vaccine to be used as a booster shot, according to a Mint report.

The company submitted the late-stage trial application to the Drugs Controller General of India (DCGI) in December 2021, sharing that a nasal vaccine as a booster dose would be easier to distribute in mass vaccination programmes.

The report stated, “DCGI’s Subject Expert Committee has granted ‘in principle’ approval to Bharat Biotech, for the conduct of Phase III superiority study and Phase III booster dose study’ for its intranasal COVID-19 vaccine, and has asked it to submit protocols for approval.”

This approval comes in the wake of rising Omicron cases in India, and is a precautionary measure.

Bharat Biotech’s intranasal vaccine, BBV154, has not yet been approved in India. The vaccine received regulatory approval for mid- to late-stage trials in August 2021, and local media reported the mid-stage trial has been completed.

India reported 58,097 new COVID-19 cases on Wednesday 5 January, bringing its total number of cases to over 35 million. A third of new infections are in Delhi and Mumbai. Delhi has now reimposed curfews and other restrictions to curb the spread of the virus, fuelled by the Omicron variant. The country is currently preparing for an increasingly likely third wave of COVID-19.

A domestically produced version of the AstraZeneca vaccine has dominated India’s vaccination drive, as well as Bharat Biotech’s inactivated Covaxin. Both are administered through injections.

Lina Adams

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