The European Medicines Agency has recommended that a vaccine with “self-amplifying” mRNA be marketed.
“On 12 December 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Kostaive, a vaccine intended for the prevention of COVID-19 in adults,” the agency said.
Kostaive will be “available as a powder for dispersion for injection,” the statement says. “Kostaive is a RNA-based COVID-19 vaccine. It contains a self-amplifying mRNA that encodes the SARS-CoV-2 spike protein. Self-amplifying means that the mRNA also carries instructions to make a protein called replicate.”
When it is administered into a muscle, the replicate protein makes copies of the mNRA, which is used to make spike proteins, the agency described.
“The benefit of Kostaive as a primary vaccination against COVID-19 was shown in a large study in which adults received either two doses of Kostaive or placebo,” the European Medicines Agency added.
The vaccine, previously approved in Japan, is the “world’s first approved replicon vaccine applying self-amplifying mRNA technology,” a press release says.
Jonathan Edelman, M.D., Senior Vice President of the Vaccines Innovation Unit at biotechnology company CSL said in September that Kostaive “has the potential to change the paradigm for COVID-19 vaccines in Japan.”
Chief Executive Officer of Arcturus Therapeutics Joseph Payne similarly said at the time, “We are pleased that our sa-mRNA technology will be available to vaccinate people in Japan
against COVID-19, which remains an ongoing risk to public health around the world.”
Five deaths occurred among those who received the self-amplifying mRNA technology during phase 3b of the vaccine trial. According to a study, none of the deaths were a direct result of the vaccine but were instead related to COVID-19 infection.
