The European Commission (EC) has approved CSL and Arcturus Therapeutics’ COVID-19 vaccine Kostaive (ARCT-154) for use in individuals aged 18 years and older.
The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and makes Kostaive the first self-amplifying messenger RNA (mRNA) COVID-19 vaccine to be approved in the EU.
mRNA is a type of genetic material containing instructions that direct the cells to make a protein, or piece of a protein, using the body’s natural machinery. The potential of the approach was brought to the fore during the COVID-19 pandemic and mRNA vaccines are now used globally to protect against the virus.
However, unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.
Among the data supporting the EC’s approval of Kostaive were the results from an integrated phase 1/2/3 study demonstrating its efficacy and tolerability, as well as the results from late-stage COVID-19 booster trials, in which Kostaive achieved higher immunogenicity results compared to a conventional mRNA COVID-19 vaccine.
Kostaive was also shown to induce superior immunogenicity and antibody persistence for up to one year post-vaccination against multiple SARS-CoV-2 strains in both younger and older adults compared to the same mRNA comparator.
Jonathan Edelman, senior vice president of CSL’s vaccines innovation unit, said the approval “marks a significant milestone” in Kostaive’s ongoing development programme, adding that the partners are “actively working to optimise [the vaccine’s] formulation to better meet the needs of healthcare professionals and their patients”.
Also commenting on the authorisation, Arcturus’ chief executive officer, said: “Kostaive and self-amplifying mRNA technology signify a major advancement in vaccine innovation, providing the potential for broader and more enduring protection. This approval highlights the clinical promise of Kostaive and its ability to protect against the ever-changing COVID-19 virus.”
CSL and Arcturus announced a strategic collaboration to develop and commercialise self-amplifying mRNA vaccines at the end of 2022. The agreement, according to the original announcement, covers vaccines for COVID-19, influenza, as well as three other globally prevalent respiratory infectious diseases.