REPLICON mRNA VACCINE (sa-mRNA) - Japan Approves World's First Self-Amplifying mRNA Vaccine (Nov.27, 2023). New nightmare hits the market. What now? What are the problems? What about shedding?

NEWS Nov.27, 2023 - Japan's Ministry of Health, Labour and Welfare Approves CSL and Arcturus Therapeutics' ARCT-154, the first Self-Amplifying mRNA vaccine approved for COVID in adults

• “historic approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine”

• CSL and Arcturus Therapeutics announced Japan's Ministry of Health, Labor and Welfare (MHLW) granted approval for ARCT-154, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for initial vaccination and booster for adults 18 years and older. 

• "Self-amplifying mRNA technology has the potential to be an enduring vaccine option," said Nobel laureate Dr. Drew Weissman, "I look forward to seeing this next generation mRNA technology protect many from COVID-19 and possibly other harmful infectious diseases."

• The approval is based on positive clinical data from several ARCT-154 studies, including an ongoing 16,000 subject efficacy study performed in Vietnam as well as a Phase 3 COVID-19 booster trial, which achieved higher immunogenicity results and a favorable safety profile compared to a standard mRNA COVID-19 vaccine comparator.  Initial study results have been published in MedRxiv and are expected to be published in a peer-reviewed journal by the end of the year.

• CSL's vaccine business, CSL Seqirus, one of the largest influenza vaccine providers in the world, partnered exclusively with Meiji Seika Pharma for distribution of the sa-mRNA COVID vaccine, ARCT 154, in Japan.

• "We are proud of the role that Arcturus has played in this collaboration to develop and validate the first approved sa-mRNA product in the world," said Joseph Payne, Chief Executive Officer of Arcturus Therapeutics (San Diego, CA)

What are self-amplifying mRNA Vaccines?