The Covid-19 nasal vaccine trial has been approved by the Dublin Pharmaceutical Institute

The Dublin Pharmaceutical Services Company has received approval from the UK Independent Regulator to begin human testing on the Intranasal Covid-19 vaccine.

Open Orphan, in collaboration with US Biotech Codegenics, is conducting the first phase of testing, which will evaluate the safety and immunity of the single-dose nasal vaccine among the 48 “healthy young adult volunteers” in the state’s subsidiary, HIVVO. Art Quarantine Facility at Whitechapel, London.

Unlike other vaccines that contain only the viral spike, COVI-VAC is one of the few vaccines that uses the “live-attenuated virus” (the whole virus is in a weakened form).

Open Orphan says the vaccine “has the ability to induce broad-spectrum antibody, cellular, and mucosal immunity with a single intranasal dose, making it one of the first vaccines to provide long-term immunity from Kovid-19.”

HVIVO expects the study to begin in January 2021 with preliminary data expected in early spring.

Kathleen Friel, executive chairman of Open Orphan, said the group was pleased to have received MHRA approval to recruit volunteers for the clinical trial.

“Volunteers attending our unique detention center in East London are expertly supervising the safe and controlled clinical environment and can contribute to the development of a new breakthrough vaccine candidate that has the potential to give individuals immunity over a longer period of time.”

“We hope this trial will demonstrate safety and immunity, which will allow us to support them as codegenics moves into a larger Phase II / Phase III program.”

Primary safety and immunogenicity data from healthy adults will help lead the company to better learning in 2021, said MDH MD Sibyl Tasker, Chief Medical Officer, Codegenics.

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“We believe that the needle – free, single-dose vaccine, COVI-VAC, is ideal for bridging global distribution gaps, as there is a significant potential for significant redundancies even after the initial roll-out of first – generation COVID – 19 vaccines.”

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