European Commission approves COVID-19 'self-amplifying' mRNA vaccine for the first time

The European Commission (EC) has granted approval for the first "self-amplifying" mRNA vaccine COVID-19.

Already on sale in Japan

The self-amplifying vaccine, called KOSTAIVE, was developed in collaboration between Australian biotech company CSL and sa-mRNA technology pioneer Arcturus Therapeutics from the US, according to a press release today.

"The KOSTAIVE vaccine is restricted to patients aged 18 years and older and is already marketed in Japan to combat COVID-19.

How does KOSTAIVE work?

During the COVID-19 pandemic, several mRNA vaccines were released, most of which received approval in Europe.

However, this is the first time the EC has approved self-amplifying vaccines, also known as sa-mRNA.

These vaccines protect against infectious diseases by giving cells in the body a blueprint for the immune system to recognise and fight disease.

Self-amplifying mRNA vaccines stimulate the body to produce more mRNA and proteins, boosting the immune response, unlike conventional mRNA vaccines.

"The EC approval is an important milestone in our ongoing KOSTAIVE development programme. We are actively working to optimise the KOSTAIVE formula to better meet the needs of healthcare professionals and their patients. As COVID-19 remains an unpredictable global threat, we are committed to completing these technical improvements and bringing this innovative vaccine to Europe as soon as possible," said Jonathan Edelman, MD, PhD, Senior Vice President, Vaccine Innovation, CSL.

Effectiveness found in all age groups

According to a press release, the EC approved the vaccine following positive clinical data from several studies. These studies confirmed the efficacy, tolerability and results of phase 3 trials of the COVID-19 vaccine for KOSTAIVE.

Additional analyses showed that the vaccine provided improved immunogenicity and antibody persistence up to 12 months post-vaccination against several SARS-CoV-2 strains in all age groups compared to a similar mRNA vaccine.

The vaccine has also received a positive opinion decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 12 December 2024, allowing it to be marketed in all EU countries.