The latest iteration of the mRNA vaccine is even more potent than the present version, as it generates more spike proteins in the human body.
Japan approved the world’s first self-amplifying mRNA (sa-RNA) COVID-19 vaccine that generates multiple mRNA copies in the body and has shown to trigger a higher rate of certain adverse events compared to Pfizer’s mRNA jabs.
Tokyo-based Meiji Seika Pharma received approval for manufacturing and marketing the “Kostaive” sa-RNA 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 phase in adults. Kostaive is the “world’s first approved vaccine” that utilizes sa-RNA technology.
Both mRNA and sa-RNA 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—sa-RNA takes this concept further by making multiple mRNA copies, which ends up generating more spike protein.
The phase 3
study compared Kostaive ARCT-154 vaccine against Pfizer’s Comirnaty mRNA COVID-19. The pre-print study, which has not been peer-reviewed, was
published in July at MedRxiv. The trial was conducted among 828 people between December 2022 and February 2023.
According to Meiji Seika Pharma, the phase 3 clinical trials for
booster shots showed that Konstaive elicited “higher and longer-lasting neutralizing antibody titers against the original strain” as well as an Omicron subvariant compared to Comirnaty.
As to adverse
reactions, Kostaive recipients reported a slightly lower number of such complications overall compared to Comirnaty. However, Kostaive recipients reported higher numbers in specific adverse events such as chills, diarrhea, dizziness, headache, malaise, nausea, and myalgia or
muscle pain.
The vaccine has been developed by
San Diego-based Arcturus Therapeutics. Meiji Seika Pharma licensed the vaccine for sale in Japan via
Melbourne-based CSL Seqirus in April this year.
The company is
collaborating with an mRNA vaccine manufacturing firm to establish facilities in Japan to produce the vaccine. Meiji Seika Pharma is working towards commercializing Kostaive in 2024.
Risks of sa-RNA
As sa-RNA vaccines produce copies of mRNA and thus boost the production of proteins, some experts are worried about the consequences it can have on the human body since any negative effects from mRNA vaccines could be amplified with injecting sa-RNA shots.
During a
testimony at the European Parliament last month, cardiologist Peter A. McCullough said that “there’s not a single study showing that the messenger RNA is broken down” in the human body once it is injected. Since the vaccines are “made synthetically, they cannot be broken down.”
The spike protein from the mRNA vaccines have been found circulating in the body even after six months from vaccination, he pointed out.
Dr. McCullough said that the spike protein is “proven” in 3,400 peer-reviewed manuscripts to cause four major domains of disease—cardiovascular, neurological disease, blood clots, and immunological abnormalities.
In a recent health
viewpoint at The Epoch Times, molecular biologist Klaus Steger noted that “a small amount of saRNA results in an increased amount of produced antigen.”
“Due to increased antigen levels, one injection of saRNA—whether linear or circular—may cause adverse events comparable with repeated (booster) injections of modRNA.”
A
study published at Trends in Biotechnology in June this year admitted that the “main challenges involved in the global authorization [of sa-RNA vaccines] are potential safety concerns regarding the replicative character of these vaccines.”
“As for all self-amplifying vaccines, concerns have been raised over adverse events in vulnerable individuals. For example, replicon (sa-RNA) vaccines could persist in immunocompromised individuals as clearance may be less efficient,” it said.
The use of sa-RNA vaccines in pregnant women also poses risks, especially if the vectors used in the vaccines come from viruses that cause congenital infections, like the Venezuelan Equine Encephalitis
Virus (VEEV), it said.
“Additional preclinical and clinical
studies are required to safeguard the implementation of replicon vaccines in vulnerable individuals.”
Safety/Efficacy Trials
In September, the safety and efficacy
results of the Kostaive vaccine were published. The trials demonstrated “acceptable safety and reactogenicity, and immunogenicity” of the vaccine.
Two doses of Kostaive were found to have an efficacy rate of 56.6 percent “against any severity of COVID-19.” In patients with severe COVID-19, efficacy was found to be 95.3 percent when the Delta variant was the predominant strain.
Kostaive “had > 90 percent efficacy against severe COVID-19 in those at risk for severe disease, those aged over 60 years, and adults from 18 to 59 years of age with underlying co-morbidities,” it said. “Efficacy against death due to COVID-19 was 86.5 percent.”
The study notes that all adverse events noted in the trials were observed to be more frequent “after vaccine than placebo.”
It points out that since most people around the world now have some immunity to the virus via natural infection or through vaccination, Kostaive is expected to be used “as a booster dose, rather than for primary immunization, to enhance and broaden the level of immunity against circulating variants.”
Commenting on the Kostaive vaccine, Mike Donio, the founder of
science education website Science Defined,
said in a Nov. 30 X post, “I’ve been saying for a while that the first generation Covid vaccines were only the start of a coming wave of mRNA therapies.”
“First, they told us that the mRNA wouldn’t persist in cells for a long time. Now they’ve unleashed self-amplifying mRNA, which means it replicates itself. Wonder how long that will last? Maybe forever? Now tell me how they don’t want to at least try to mess with our genetics.”
The Epoch Times reached out to Meiji Holdings for comment.
