Tokyo-based pharmaceutical company Meiji Seika Pharma has received approval in Japan for the production and distribution of the world's first self-amplifying mRNA Wuhan coronavirus (COVID-19) vaccine, even without safety data.
The vaccine named Kostaive is designed to trigger a strong immune response and potentially offer prolonged protection by instructing cells to produce multiple copies of the viral spike protein. RNA vaccines, commonly known as sa-mRNA and mRNA vaccines, use the virus's genetic code against it. An mRNA vaccine boosts the immune system by instructing cells to produce a specific protein, while a sa-mRNA vaccine generates more spike protein.
In a Nov. 28 press statement, Meiji Seika Pharma announced its approval to produce and distribute the world's first approved product using self-amplifying mRNA technology – the Kostaive sa-mRNA vaccine. The vaccination protocol for Kostaive includes both booster shots and two doses of the main vaccine for the adult population.
However, no matter how promising, critics are concerned about the limited safety testing.
Toby Young, general secretary of the Free Speech Union, stated on Nov. 30 that the vaccine was tested on only 800 people without a control group and the assessment was limited to antibody levels rather than infection rates.
Notably, the trial for Kostaive involved only 828 participants between December 2022 and February 2023, a significantly smaller number compared to Pfizer's phase three trial with approximately 40,000 participants. The pre-print study suggested that Kostaive recipients experienced a slightly lower frequency of localized responses but reported more instances of certain side effects compared to Comirnaty, including fever, diarrhea, headache, nausea, malaise, chills and myalgia.
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Researchers also compared the Kostaive ARCT-154 vaccine with Pfizer's mRNA COVID-19 vaccine in a Phase 3 study published in July on MedRxiv; however, it has not undergone peer review.
Experts highlight the adverse effects of mRNA vaccines
Aside from the limited safety testing, experts stressed the negative effects of increasing the creation of proteins by producing copies of mRNA.
In a testimony before the European Parliament, renowned cardiologist Dr. Peter McCullough stated that there is no evidence proving the breakdown of mRNA in the body after injection. He emphasized that these vaccines, being synthetically made, might persist in the body for up to six months after immunization.
McCullough further linked the spike protein from mRNA vaccines to various health issues, including blood clots, neurological disorders, cardiovascular diseases and immunological problems, citing 3,400 peer-reviewed publications as evidence. (Related: Dr. Peter McCullough: COVID shots should be taken completely off the market.)
Molecular researcher Klaus Steger also pointed out that even a small amount of sa-mRNA could lead to increased production of antigens.
"Due to increased antigen levels, one injection of saRNA – whether linear or circular – may cause adverse events comparable with repeated (booster) injections of modRNA," Steger said.
A study published in the journal Trends in Biotechnology in June highlighted safety issues associated with sa-mRNA vaccines, particularly related to their replicative nature. The study suggested that these vaccines might persist in immunocompromised individuals. Additionally, hazards were identified for pregnant women, especially if the vaccine vectors were derived from viruses causing congenital diseases.
Mike Donio, the creator of the science education website Science Defined, has expressed doubts about the sa-mRNA technology in his post on X.
"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," he wrote.
Head over to DangerousMedicine.com for more stories about the dangers of the mRNA COVID-19 vaccines.
Watch Florida Surgeon General Dr. Joseph Ladapo expound on the mRNA COVID-19 injections' terrible safety profile below.
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