Dublin pharmaceutical firm gets approval for Covid-19 nasal vaccine trial

Open Orphan's vaccine is one of the first to use the entire virus in weakened form meaning it has the potential to provide long-term immunity 
Dublin pharmaceutical firm gets approval for Covid-19 nasal vaccine trial

Cathal Friel, CEO of Open Orphan 

A Dublin pharmaceutical services company has received approval from the UK's independent regulator to begin human trials on its intranasal COVID-19 vaccine.

Open Orphan is working in collaboration with US biotech Codagenix to conduct the first phase of trials which will evaluate the safety and immunogenicity of a single-dose nasal vaccine in 48 “healthy young adult volunteers” at the group's subsidiary hVIVO's state-of-the-art Quarantine Facility in Whitechapel, London.

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

Open Orphan says this means the vaccine has the potential “to induce broad antibody, cellular and mucosal immunity with a single intranasal dose and could be one of the first vaccines to provide long-term immunity from COVID-19.”[social=twitter]

https://twitter.com/OpenOrphan/status/1318439660767617024[/social]

hVIVO expects the study to commence in January 2021 with the initial data expected in early spring.

Cathal Friel, Executive Chairman of Open Orphan, said the group is delighted to have MHRA approval to begin recruiting volunteers for the clinical trial. 

"The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale."

"We hope to demonstrate safety and immunogenicity through this trial, which will then allow us to support Codagenix as they move into a larger Phase II / Phase III programme."

Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said the initial safety and immunogenicity data from healthy adults will position the company well to move into larger studies in 2021. 

"We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines."

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