sa-mRNA COVID-19 Vaccine Authorized in Europe

CSL and Arcturus Therapeutics recently announced that the European Commission (EC) has granted marketing authorization for KOSTAIVE ®, a self-amplifying mRNA COVID-19 vaccine, for individuals 18 and older.

KOSTAIVE (ARCT-154)is the first sa-mRNA COVID-19 vaccine to receive approval from the EC.

"KOSTAIVE and sa-mRNA technology signify a major advancement in vaccine innovation, providing the potential for broader and more enduring protection," said Joseph Payne, CEO of Arcturus, in a press release on February 14, 2025.

"This approval highlights the clinical promise of KOSTAIVE and its ability to protect against the ever-changing COVID-19 virus."

Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.

KOSTAIVE is currently marketed in Japan against COVID-19.