Japan Approves World’s First ‘Self-Amplifying’ mRNA COVID-19 Vaccine Without Published Efficacy Or Safety Data

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 immunisation (2 doses) as well as booster immunisation 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 an immune response. An sa-mRNA vaccine takes this concept further by making multiple mRNA copies, which ends up generating more spike protein.

Toby Young, general secretary of the Free Speech Union, a public interest group, pointed out in a Nov. 30 X post that the sa-mRNA vaccine was approved in Japan “despite only testing it on 800 people, no control group, and only checking antibody levels, not infection rates. Medical regulation died with COVID.”

A phase 3 study compared the Kostaive ARCT-154 vaccine to Pfizer’s Comirnaty mRNA COVID-19 vaccine. The pre-print study, which has not been peer-reviewed, was posted in July at MedRxiv.

The study, funded by the Japanese Ministry of Health, Labour, and Welfare, followed a primary phase study that analyzed the safety and efficacy of the Kostaive vaccine. The results of that study have not been published; the manuscript is “in preparation,” according to the phase 3 study report.

The trial was conducted among 828 people between December 2022 and February 2023. This is a far lower number of participants than Pfizer’s phase 3 study, which involved over 40,000 individuals. The small scale of the Kostaive trial has raised questions about its validity.

According to the pre-print study, Kostaive recipients reported a slightly lower number of localised reactions—such as localised pain or swelling—compared to Comirnaty. However, Kostaive recipients reported higher numbers of specific adverse events such as chills, diarrhoea, dizziness, headache, malaise, nausea, myalgia, or muscle pain.

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.

The vaccine was developed by San Diego-based Arcturus Therapeutics. Meiji Seika Pharma licenced the vaccine for sale in Japan via Melbourne-based CSL Seqirus in April of this year.

The company is collaborating with Arcalis, an mRNA vaccine manufacturing firm, to establish manufacturing capabilities in Japan. Meiji Seika Pharma is working towards commercialising Kostaive in 2024.

As sa-mRNA vaccines produce copies of mRNA and thus boost the production of proteins, some experts are worried about the consequences they can have on the human body and concerned that any negative effects from mRNA vaccines could be amplified by injecting sa-mRNA shots.

During testimony at the European Parliament last month, cardiologist Peter 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 has been found circulating in the body as long as six months after 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 Epoch Times article, molecular biologist Klaus Steger noted that “a small amount of saRNA [sa-mRNA] 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.”

Mr. Steger had previously pointed out that BioNTech’s “mRNA” vaccines are made not with messenger RNA but with modified RNA (modRNA).

A study published in the journal Trends in Biotechnology in June this year admitted that the “main challenges involved in the global authorization [of sa-mRNA 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-mRNA] vaccines could persist in immunocompromised individuals as clearance may be less efficient,” it said.

The use of sa-mRNA 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, the study said.

“Additional preclinical and clinical studies are required to safeguard the implementation of replicon vaccines in vulnerable individuals,” it cautioned.

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. I 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.”

Comments