The vaccine is intended for preliminary vaccination and as a booster in those aged 18 years and above.
The development is based on positive data from clinical trials of ARCT-154. The studies include a 16,000-participant trial in Vietnam and a Phase III Covid-19 booster trial.
In the booster trial, the vaccine demonstrated increased immunogenicity and a favourable safety profile versus a standard mRNA Covid-19 vaccine.
CSL vaccines innovation unit senior vice-president Jonathan Edelman stated: “The approval marks a historic and exciting milestone as the first sa-mRNA vaccine in the world to be registered, and supports CSL’s promise to protect global public health.
“We are committed to working with health authorities around the world to ensure this important vaccine technology will be available to people at risk for Covid-19.”
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CSL’s vaccine business Seqirus collaborated with Meiji Seika Pharma to supply ARCT-154 in Japan.
It is the first sa-mRNA Covid-19 vaccine across the globe to gain approval.
In 2022, CSL and Arcturus entered into a worldwide partnership and licencing deal for the vaccine platform technology.
It was agreed that CSL would hold an exclusive licence to use Arcturus’ mRNA technology for influenza, Covid-19 and other respiratory viral ailments.
CSL also has a non-exclusive licence for the technology in the area of multi-pathogen pandemic readiness.
Arcturus Therapeutics CEO Joseph Payne stated: “We are proud of the role that Arcturus has played in this collaboration to develop and validate the first approved sa-mRNA product in the world.
“This approval for the sa-mRNA Covid-19 vaccine is a major achievement, and we are excited to embark on future endeavours that utilise our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL.”
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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