Bharat Biotech Seeks DCGI Nod for Clinical Trials of Intranasal COVID-19 Booster

The booster can be administered to Covaxin-vaccinated persons as well as those who have received Covishield.

The Quint
COVID-19
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<div class="paragraphs"><p>Indian drugmaker Bharat Biotech on Monday, 20 December, sought approval from the Drug Controller General of India (DCGI) for the conduction of phase-3 trials for its intranasal vaccine (BBV154), which is to be used as a booster dose.</p></div>
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Indian drugmaker Bharat Biotech on Monday, 20 December, sought approval from the Drug Controller General of India (DCGI) for the conduction of phase-3 trials for its intranasal vaccine (BBV154), which is to be used as a booster dose.

(Photo: iStock)

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Indian drugmaker Bharat Biotech on Monday, 20 December, sought approval from the Drug Controller General of India (DCGI) for the conduction of phase-3 trials for its intranasal vaccine (BBV154), which is to be used as a booster dose.

"The application has been filed and the company is awaiting approval from the drug regulator. The intranasal vaccine will be administered to those who have already taken their two doses," sources told news agency PTI.

The vaccine can be administered to Covaxin-vaccinated persons as well as those who have been inoculated by Serum Institute of India-manufactured Covishield, sources told news agency ANI.

An intranasal vaccine is easier to administer in mass vaccination campaigns, the sources noted.

Union Health Minister Mansukh Mandaviya, earlier in December, had informed the Lok Sabha that the government was considering the need for a booster dose.

In its weekly bulletin dated 29 November, the Indian SARS-CoV-2 Genomics Consortium (INSACOG) has recommended that the government should consider COVID booster dose for people who are 40-years-old and above amid the concerns revolving around the Omicron variant of coronavirus.

"Vaccination of all remaining unvaccinated at-risk people and consideration of a booster dose for those 40 years of age and over, first targeting the most high-risk/high-exposure may be considered, since low levels of neutralising antibodies from current vaccines are unlikely to be sufficient to neutralise Omicron, although risk of severe disease is still likely to be reduced," the weekly bulletin had mentioned.

(With inputs from ANI and PTI)

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