After years of injecting themselves with foreign-made mRNA injections, patriotic Japanese Covidians will finally get the chance to put some domestically made lipid nanoparticles into their bloodstreams. From NHK World:
A Japanese Health Ministry panel has said a coronavirus vaccine developed by Daiichi Sankyo can be used for inoculations in Japan. It would be the first Japanese-made Covid shot available for practical use.
Would you be surprised to know that the majority of the panel still wears masks?
The panel of experts held a meeting on Monday. The experts said they confirmed the vaccine’s effectiveness, and that they have no serious concerns over its safety.
Banzai! Unfortunately, the article doesn’t give any details of the effectiveness the experts apparently confirmed. Fortunately, Daiichi-Sankyo previously put out a press release joyously announcing that the primary endpoint had been reached in the Phase Three trial of their Covid vaccine (DS-5670). So did DS-5670 reach 95% effectiveness like Pfizer/BioNTech and Moderna did?
The primary endpoints of the booster vaccination trial were the geometric mean blood neutralising antibody titer and immune response against SARS-CoV-2 (Omicron BA.5 subvariant) four weeks after the investigational vaccination. Results on the endpoints in the DS-5670 group were higher than those in the control group (Omicron-adapted bivalent vaccine approved in Japan), statistically demonstrating non-inferiority of DS-5670.
In other words, DS-5670 produced more antibodies against BA.5 than the Pfizer/BioNTech or Moderna bivalent jab, neither of which has ever been shown to be effective. How many more? Dunno yet.
Detailed results from the booster vaccination trial will be presented at academic conferences and in publications.
You may be thinking, “Hang on. Are you telling me that Japan just approved a completely new Covid jab based on unpublished antibody titers?” Yep, that’s exactly what I’m telling you.
But Daiichi-Sankyo is using the same mRNA platform as Pfizer/BioNTech and Moderna, so at least the Ministry of Health, Labour, and Welfare (MHLW) is not green-lighting new technology for them…
Rise of the Replicons
Unlike for Meiji Seika Pharma, where the MHLW is green-lighting new technology for a second new Covid jab. From the company’s press release:
Meiji Seika Pharma Co., Ltd. announced today that it has received approval for the manufacturing and marketing of ‘Kostaive™ for Intramuscular Injection’ (ARCT-154), a self-amplifying mRNA vaccine against COVID-19, from the Ministry of Health, Labour and Welfare (MHLW) in Japan. [emphasis added, here and below]
This is the world’s first approval of a self-amplifying mRNA vaccine. So what’s a self-amplifying mRNA vaccine? An mRNA vaccine that self-amplifies, obviously.
The mRNA in Kostaive is designed to self-amplify once delivered into cells, so that it generates a strong immune response and the potential for extended duration of protection while using lower doses of mRNA compared to existing mRNA vaccines.
In other words, your cells can become even more efficient mRNA factories. The below image and description come from an article in the top immunology journal Cell ominously titled ‘Rise of the RNA machines – self-amplification in mRNA vaccine design‘. Note that self-amplifying mRNA can also be called replicon RNA.
Once released in the cell, the mRNA is translated to produce the protein of interest. In contrast to mRNA, replicon RNA encodes alongside the protein of interest, self-amplifying genes (depicted in blue) that amplify the replicon RNA. This intracellular amplification will subsequently result in higher expression levels of the protein of interest.
I don’t claim expertise here, but I doubt this is going to fix the problem of spike protein overproduction seen with the original mRNA platform. The Cell article even suggests as much.
At present, the main challenges involved in the global authorisation are potential safety concerns regarding the replicative character of these vaccines… For example, replicon vaccines could persist in immunocompromised individuals as clearance may be less efficient.
Because no other self-amplifying mRNA vaccine has previously been approved, the MHLW at least demanded the company do a large-scale randomised controlled trial to test the jab’s real-world effectiveness against infection and severe disease, right? Haha, no. Back to the press release.
In the Phase III clinical trials for booster vaccination conducted in Japan, 5 μg Kostaive™ elicited higher (p<0.05) and longer-lasting neutralising antibody titers against the original strain, as well as the Omicron BA 4-5 subvariant, compared to 30 μg COMIRNATY ® , a licensed conventional mRNA vaccine targeting COVID-19.
At least this time there’s a pre-print available (here). Whereas the Phase Three trial for Pfizer/BNT’s Comirnaty started with about 40,000 unvaxed participants, this one had only 828, who’d all had three shots previously. Such a small-scale trial clearly can’t tell us if the new platform causes any of the same safety issues associated with the original platform let alone any different ones (which is kind of the point). But Kostaive (ARCT-154) interestingly still managed to, er, amplify the rates of chills, headaches and myalgia (muscle aches and pains) compared with Comirnaty despite one sixth of the dosage. That’s the magic of self-amplification, I guess.
However, the version of Kostaive in the trial targeted the wild-type virus that went out of circulation in early 2021, so Meiji Seika Pharma won’t release that one. Instead, the company plans to release an updated version of Kostaive in 2024 and is currently conducting another Phase Three trial of a bivalent version, again comparing antibody titers.
So not only did the MHLW approve a vaccine that uses new technology based on antibody titers, it didn’t even approve it based on antibody titers from the vaccine that will actually be released. The old definition of ‘regulation’, like those of ‘safe’ and ‘effective’, appears to have died due to Covid.
This seems to be one of the enduring legacies of the COVID-19 pandemic: regulatory agencies have dropped the pretence of doing their jobs properly and will happily rubber stamp any application for approval from favoured companies on the basis of essentially meaningless data. Despite what they claim, the MHLW’s experts haven’t confirmed that the new jabs offer any benefit to anyone other than the vaccine makers, but they have confirmed that they themselves certainly don’t.
This article first appeared on Guy Gin’s Substack page, Making (Covid) Waves in Japan. Subscribe here.
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And they can jolly well inject it where the sun don’t shine, Bloody idiots!
In Japan, that can be tight.
Actually that’s quite the untapped market. Imagine if you could deliver mRNA gunk into your system via a suppository? I’d bet money that the Covidian vaxtards would totally go for it if you told them they wouldn’t catch a cold/”deadly virus”. They’re that far gone. It’d be like an alternative to the famous Asch experiment on conformity.
Did you misshpell Asch?
No, that looks correct – Solomon Asch Experiment, for it’s full name.
at the risk of trying to point out a joke, thus eradiacting the humour.
…topic being vax-suppositories; reference to the Asch experiment.
…not wishing to mishspell, etc.
>sean connery voice>
I give up. Open goal. Failed penalty kick.
Ahhhsohl.
This one would be good with Connery voice?
oops dupe comment.
But it’s the land of the rising sun!
Perhaps Northern Sweden would be a better bet.. 
Do you recall when the Chinese insisted that anyone coming into China had to have anal swabs as China had decided this would be better. Actually, this is similar to what China did to the rest of the world, and the majority willingly asked for it.
https://www.youtube.com/watch?v=HhDpR7h6yiU
Most Kenyans don’t welcome the anal swab for testing COVID-19 deployed in China
And this one…
https://www.youtube.com/watch?v=KZXDVMn6ce4
China shuts down viral video after anal Covid test accusation | Cobrapost
And…There is still the bloody NHS strapline below these videos about getting the latest information from the NHS about coronavirus. The latest info!!! It’s been 4 years!!!
Love it.
Anal Swab- Claus Schwab ,the same thing really!
https://www.gbnews.com/news/albanians-london-fireworks-met-police-celebrate-independence-day
Albanian soldiers running bloody riot again.
This was my concern. They see the Pfizer trial as approval of the ‘mechanism’ not the product itself.
My analogy is the approving of the missile launcher, not the missile. The faulty assumption being that all missiles will be equal. The initial one could be a confetti bomb, one day it could be a nuke.
That this tech can be programmed to deliver different payloads is no doubt part of the business case.
Another concern is the focus on short-term antibodies, which is a proxy trial endpoint (in the same way as cholesterol levels are treated as a proxy for heart disease with statins). The real endpoint should be whether people get ill, but since the virus is now weaker, nobody will get ill. So they’ll cheat and the regulators nod sagely.
Your long term immune system is based on t-cells, of which I believe there are several types, some more important than others in determining efficacy. Not an expert but I recently listened to Angus Dalgleish explain this.
Doctoring Data by Malcolm Campbell discusses in great detail how the way clinical trials can be obfuscated to appear successful.
Dr Malcolm Kendrick :- https://drmalcolmkendrick.org/
Thank you Baldrick for correcting my brain-fart.
I was in the pub so unable… (well, generally unable…)
It’s an interesting book though.
So are his other two tomes …
Soon everything will be mRNA based.
The death of the human being.
https://hatchardreport.media/pdf-files/the-big-picture-we-have-jumped-off-an-evolutionary-cliff.pdf
Not only is there a looming disaster with the range of damage caused by any of the 28 different vaccines/’vaccines’ and the unknown long term effect, but there will also be a growing disaster caused by giving blood transfusions from those injected with experimental ‘vaccines’.
The thing is people rocking up for all jabs is declining seeing as trust is rightly waning. Therefore, what with ethics now a thing of the distant past, they’re going to have to come up with novel but ingenious ways of getting the toxic crud into us. It wouldn’t surprise me at all if they start putting it in other stuff. For instance, if they put it in contact lens solution certainly I’ll be royally screwed. I mean, it’s not beyond the realms of possibility that the stuff could be absorbed through your eyeballs. And what about deodorant? I avoid ones with aluminium in but they could easily stabilize mRNA so it could live in your roll-on or aerosol deodorant and you get it delivered transdermally. They’re already putting it in food, aerosol vaccines are a thing, water supply?…the possibilities are endless when you try and put yourself in the mind of a mad, evil scientist really..
I do recall either Mr Gates or someone waxing lyrical about putting vaccines in food. Mad, evil scientists indeed.
https://youtu.be/kZ26Sqk9C8k?si=C1-ctE_V22jRfcFe
Mogs take a look at this short vid from Dr Sam Bailey.
I have ditched shampoo, most soap and all conventional deodorants. Nobody says I have BO. My hair is no better or worse and we are saving a few coppers.
Too much unnecessary pharmacology in our daily lives.
Japanese birthrates are already dire, well below the 2.1 replacement rate. Looks like they are deliberately trying to reduce it still further.
They are doing a third stage trial. That means 10 years of data, and it cannot possibly have been approved properly. I suggest brown envelopes are present. Well Japaneese gineau pigs are probably as good as any other creatures. I hope full disclosure takes place this time, it certainly didn’t in the UK.