Tokyo-based Meiji Seika Pharma has received approval in Japan to produce the world’s first self-amplifying mRNA COVID-19 vaccine without safety data.
The world’s first COVID-19 self-amplifying mRNA (sa-mRNA) vaccine has been authorized in Japan; however, the vaccine’s maker has not released any safety or effectiveness information.
In a press statement on November 28, Tokyo-based Meiji Seika Pharma stated that it has acquired approval to begin producing and selling its Kostaive sa-mRNA COVID-19 vaccine. When the vaccine’s mRNA enters cells, it is intended to self-amplify, resulting in a “strong immune response and the potential for extended duration of protection.” The adult population is meant to receive both booster shots and two doses of the main vaccination from this vaccine. According to the press release, Kostaive is the “world’s first approved product applying self-amplifying mRNA technology.”
RNA vaccinations that use a virus’s genetic code against it are known as sa-mRNA and mRNA vaccines. An mRNA vaccine boosts the immune system by telling cells to produce a certain protein when administered intraperitoneally. By producing multiple mRNA copies, a sa-mRNA vaccine extends this idea by producing more spike protein.
In an article published on Nov. 30, Toby Young, general secretary of the public interest group Free Speech Union, noted that the sa-mRNA vaccine received approval in Japan “despite only testing it on 800 people, no control group, and only checking antibody levels, not infection rates.” With COVID-19, medicine regulation was killed.
The Kostaive ARCT-154 vaccine and Pfizer’s Comirnaty mRNA COVID-19 vaccine were contrasted in a phase 3 research. The pre-print research was published in July at MedRxiv and has not undergone peer review.
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The study was carried out after a primary phase study that examined the safety and effectiveness of the Kostaive vaccine. The Japanese Ministry of Health, Labour, and Welfare supported it. The phase 3 study report states that the manuscript is “in preparation,” although the study’s findings have not yet been published.
828 individuals participated in the trial, which took place between December 2022 and February 2023. Comparing this to Pfizer’s phase 3 trial, which included approximately 40,000 participants, the number of participants is much fewer. The legality of the Kostaive trial has been questioned because of its tiny nature.
The pre-print study indicates that compared to Comirnaty, Kostaive recipients reported a somewhat decreased frequency of localized responses, such as localized discomfort or edema. On the other hand, Kostaive recipients reported more instances of some side effects, including fever, diarrhea, headache, nausea, malaise, chills, myalgia, or muscle soreness.
Meiji Seika Pharma claims that in comparison to Comirnaty, Konstaive produced “higher and longer-lasting neutralizing antibody titers against the original strain” as well as an Omicron subvariant in phase 3 clinical trials for booster doses.
Arcturus Therapeutics, located in San Diego, produced the vaccine. In April of this year, Meiji Seika Pharma granted CSL Seqirus, located in Melbourne, a license to sell the vaccine in Japan.
To create production capabilities in Japan, the company is working with Arcalis, a company that manufactures mRNA vaccines. The goal of Meiji Seika Pharma is to bring Kostaive to market by 2024.
Risks of sa-mRNA
Some researchers are concerned about the effects that sa-mRNA vaccinations may have on the human body and that injecting sa-mRNA injections may amplify any negative effects from mRNA vaccines since they increase the creation of proteins by producing copies of mRNA.
According to cardiologist Peter McCullough, “there is not a single study showing that the messenger RNA is broken down” in the human body after injection, during testimony before the European Parliament last month. The vaccinations “cannot be broken down because they are made synthetically.”
He noted that up to six months after immunization, the spike protein from the mRNA vaccines has been discovered to remain circulating in the body.
According to Dr. McCullough, 3,400 peer-reviewed publications have “proven” that the spike protein causes four main types of disease: blood clots, neurological disorders, cardiovascular disease, and immunological problems.
“A small amount of saRNA [sa-mRNA] results in an increased amount of produced antigen,” according to molecular researcher Klaus Steger.
“Due to increased antigen levels, one injection of saRNA—whether linear or circular—may cause adverse events comparable with repeated (booster) injections of modRNA.”
As Mr. Steger has previously noted, modified RNA (modRNA) is used instead of messenger RNA in the production of BioNTech’s “mRNA” vaccines.
In June of this year, a study that was published in the journal Trends in Biotechnology acknowledged that the primary obstacles to the worldwide approval of sa-mRNA vaccines are possible safety issues related to the vaccinations’ replicative nature.
“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.
According to the study, there are hazards associated with using sa-mRNA vaccinations in pregnant women, particularly if the vaccines’ vectors originate from viruses that cause congenital diseases like the Venezuelan Equine Encephalitis Virus.
“Additional preclinical and clinical studies are required to safeguard the implementation of replicon vaccines in vulnerable individuals,” it cautioned.
The creator of the science education website Science Defined, Mike Donio, commented on the Kostaive vaccine in a Nov. 30 X post, saying, “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.”
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