World’s first self-amplifying COVID-19 vaccine approved in Japan despite lack of safety data
By Cassie B. // Dec 13, 2023

Japan has just given the stamp of approval to a pioneering, self-amplifying mRNA vaccine despite a dearth of evidence that it is safe or effective.

The Japanese company Meiji Seika Pharma is behind the vaccine, which is known as the Kostaive sa-mRNA COVID-19 vaccine and is considered the first in the world of its kind. It works by self-amplifying after being delivered into the body’s cells. This leads to what they claim is a “strong immune response and the potential for extended duration of protection.”

When conventional mRNA vaccines are injected into the body, the mRNA tells cells to create a specific protein, which spurs an immune response. With self-amplifying mRNA vaccines, multiple mRNA copies are made, which creates even more spike protein – and if the current mRNA vaccines have taught us anything, it’s that this is unlikely to end well.

Much like the traditional mRNA COVID-19 vaccines forced upon the world in recent years, the plan for these vaccines is to convince people they need two doses of primary immunization followed by boosters.

Lack of testing raising concerns

Although there is a lot to be worried about here, one of the biggest concerns is the lack of testing the jab has undergone. A trial took place from December 2022 to February 2023 involving just 828 individuals. To put this in perspective, 40,000 people took part in the phase 3 study for Pfizer’s COVID-19 vaccine.

Meiji Seika Pharma claims that its clinical trials showed that the booster of its vaccine led to “higher and longer-lasting neutralizing antibody titers against the original strain” and a subvariant of Omicron than Pfizer’s vaccine. And while recipients of the Kostaive vaccine did experience fewer localized reactions like pain and swelling at the jab site, they actually had higher numbers of several specific side effects, such as muscle pain, headache, chills, nausea, myalgia, malaise, dizziness and diarrhea.

The company hopes to have the vaccine ready for the market next year.

Potential side effects of sa-mRNA vaccines

Some experts are concerned that because these vaccines amplify the action of the current mRNA vaccines, they could also amplify the long and deadly list of adverse effects associated with them.

The spike protein in particular has been singled out as a factor in four domains of disease linked to the jabs: blood clots, immunological abnormalities, neurological diseases and cardiovascular effects.

Molecular biologist Klaus Steger told the Epoch Times that small amounts of self-amplifying mRNA lead to greater antigen production.

“Due to increased antigen levels, one injection of saRNA—whether linear or circular—may cause adverse events comparable with repeated (booster) injections of modRNA,” he cautioned.

A study published in the journal Trends in Biotechnology pointed to other potential safety issues with these vaccines despite declaring them promising overall. It points out that these replicon vaccines can persist in people who are immunocompromised and may therefore not be able to clear them from their bodies. The authors also drew attention to the ability of these vaccines to recombine with circulating viruses, which is something that needs to be studied further.

The study also said there could be safety concerns for pregnant women using these types of vaccines, especially when they are made with replicon vectors that were derived from viruses that may cause congenital infections. Although they say “it is not expected to affect the development of the fetus,” this is hardly a confident statement, and the study’s authors insist that further studies are needed to explore the effects of these vaccines in vulnerable people.

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