Japan Approves World’s First ‘Self-Amplifying’ mRNA COVID-19 Vaccine Without Published Efficacy Or Safety Data
11th December 2023
Japan has approved the world’s first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine, although the manufacturer has not published safety or efficacy data for the shot.
Tokyo-based Meiji Seika Pharma received approval for manufacturing and marketing its Kostaive sa-mRNA COVID-19 vaccine, the company announced in a Nov. 28 press release. The mRNA in the vaccine is designed to self-amplify when delivered into cells, which generates a “strong immune response and the potential for extended duration of protection.” The vaccine is intended for primary immunization (2 doses) as well as booster immunization in adults. Kostaive is the “world’s first approved product applying self-amplifying mRNA technology,” according to the press release.
Both mRNA and sa-mRNA are RNA vaccines that use a virus’ genetic code against it. When an mRNA vaccine is injected into an individual, the mRNA instructs cells to make a specific protein and thus stimulates immune response. An sa-mRNA vaccine takes this concept