There has been quite a bit of talk for the past year or so regarding self-amplifying mRNA (sa-mRNA) vaccines.
As usual, there are some facts, some rumors and some speculation. This article will provide links to a few recent key events, keeping commentary to a minimum.
Japan’s Ministry of Health, Labor and Welfare (MHLW) granted approvals in late 2023 and early 2024 for Arcturus Therapeutics and CSL’s ARCT-154 sa-mRNA vaccine (also known under the brand name Kostaive).
Japan’s MHLW then granted approval in September 2024 for ARCT-154 to deal with JN.1 (which is a sub-variant of the COVID-19 Omicron variant BA.2.86).
It should be noted that CSL (Commonwealth Serum Laboratories) was founded in 1916 as a department of the Australian government and privatized in 1994. Arcturus Therapeutics was founded in 2013 and is based in San Diego, California.
The US Food and Drug Administration (FDA) issued in November 2024 a “Study Can Proceed” notification for ARCT-2304 “as a potential vaccine to protect against the highly pathogenic H5N1 avian influenza”.
The European Medicines Agency (EMA) “adopted a positive opinion” in December 2024 for Kostaive which will be “available as a powder for dispersion for injection”.
By the way, the Bill & Melinda Gates Foundation has committed a small grant to Arcturus Therapeutics.
A Japanese study by Y. Oda et al titled “Persistence of immune responses of a self-amplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2” published on 1 February 2024 compared 420 individuals who received the ARCT-154 to 408 individuals who received the BNT162b2 as the second booster up to 181 days after administration. If one thinks the persistence of spike proteins from the Pfizer mRNA injection is bad, then look at the antibody levels of the ARCT-2304 sa-mRNA injection in the figure reproduced below. Note the scale is logarithmic. Also note that ARCT-154 contains 5μg of mRNA while BNT162b2 contains 30μg.
On a slightly different note, it is reported that under the $2-billion Australia–Moderna deal for its injections to be manufactured in Melbourne, the so-called vaccines are to be exempted from assessments by the Pharmaceutical Benefits Advisory Committee (PBAC).
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