The European Commission has granted approval for the first “self-amplifying” mRNA COVID-19 vaccine.
A press release on 14 February reveals that the vaccine called KOSTAIVE was developed jointly by biotechnology company CSL and sa-mRNA pioneer Arcturus Therapeutics.
KOSTAIVE is used exclusively for patients 18 years or older, and is already being marketed in Japan against COVID-19.
A new approach to COVID-19
The COVID-19 pandemic saw the release of several mRNA vaccines, many of which were approved in Europe.
However, this is the first time the commission is approving self-amplifying vaccines, also known as sa-mRNA.
This is a type of vaccine that helps protect against infectious diseases by providing a blueprint for cells in the body for immune systems to recognize and fight the disease.
Self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response, unlike conventional mRNA vaccines.
Commenting on the approval, Jonathan Edelman, MD, Senior Vice President of the Vaccines Innovation Unit, at CSL said:
“The European Commission’s approval marks a significant milestone in our ongoing development program for KOSTAIVE. We are actively working to optimize KOSTAIVE’s formulation to better meet the needs of healthcare professionals and their patients. As COVID-19 remains an unpredictable global threat, CSL is dedicated to completing these technical enhancements and making this innovative vaccine available in Europe as soon as possible.”
According to the press release, the commission approved the vaccine after positive clinical data from several studies demonstrating KOSTAIVE’s efficacy, tolerability, and Phase 3 COVID-19 booster trials were provided.
A further analysis of a booster dose also showed that the vaccine elicited superior immunogenicity and antibody persistence for up to 12 months post-vaccination against multiple SARS-CoV-2 strains in all age groups compared to the same mRNA comparator.
The vaccine has also received a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024, making it valid for marketing in all EU states.
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