In a groundbreaking development in the field of medical science, Japan has become the first country to grant full regulatory approval to a self-amplifying RNA (saRNA) vaccine for COVID-19. The vaccine, ARCT-154, developed by Arcturus Therapeutics and CSL, marks a significant advancement in vaccine technology, offering a new approach to combating infectious diseases and potentially cancer. Â
Unlike traditional messenger RNA (mRNA) vaccines, saRNA vaccines like ARCT-154 have the unique ability to replicate themselves within cells. This innovative feature means that lower doses can be used, potentially reducing side effects and manufacturing costs. In clinical testing, ARCT-154 has been shown to trigger higher levels of virus-fighting antibodies that persist longer than those stimulated by standard mRNA COVID-19 vaccines. Â
The development of ARCT-154 represents over two decades of research in saRNA technology. Its approval is a testament to the perseverance and innovation in the field of vaccine research. “Being the first to bring an approval for this platform is pretty huge,” says Roberta Duncan, RNA-programme leader at CSL. The vaccine’s antigen is a surface protein expressed by SARS-CoV-2, with replication machinery derived from a mosquito-borne pathogen, modified to be non-infectious and safe for human use. Â
The saRNA platform offers several advantages over conventional mRNA vaccines, including the potential for lower doses and reduced reactogenicity. However, the technology is not without challenges. The longer genetic sequences in saRNA vaccines add complexity to the manufacturing process, and the intricate interaction with the immune system requires careful balancing to avoid counterproductive responses. Â
With ARCT-154’s approval, the focus now shifts to its broader applications. More than a dozen saRNA vaccine candidates are in clinical trials for various diseases, including shingles, flu, and cancer. Researchers are also exploring the use of saRNA technology for in-body production of therapeutic proteins, a concept that could revolutionize treatment methodologies. Â
The approval of ARCT-154 in Japan is seen as a significant milestone in the vaccine industry. Its developers are now seeking authorization in Europe, with a decision expected next year. This approval could pave the way for the wider acceptance and development of saRNA-based vaccines, potentially impacting global health, especially in pandemic preparedness and response. Â
The approval of the world’s first saRNA vaccine in Japan marks a pivotal moment in medical science. As the world continues to grapple with various health challenges, the emergence of saRNA technology offers a promising new tool in the fight against infectious diseases and beyond. The global health community watches with anticipation as this new chapter in vaccine technology unfolds. Â
Journal Reference Â
Dolgin, E. (2023). Self-copying RNA vaccine wins first full approval: what’s next? Retrieved from https://www.nature.com/articles/d41586-023-03859-wÂ
