First-Ever ‘Self-Amplifying mRNA’ Covid Shot Is Launched...
Dec 3, 2023 16:26:04 GMT -5
Post by schwartzie on Dec 3, 2023 16:26:04 GMT -5
First-Ever ‘Self-Amplifying mRNA’ Covid Shot Is Launched with No Safety Data
Frank Bergman
December 3, 2023 - 12:29 pm
Japan has just approved the first-ever “self-amplifying mRNA” Covid shot, despite having no safety or efficiency data.
“A Japanese Health Ministry panel has said a coronavirus vaccine developed by Daiichi Sankyo can be used for inoculations in Japan,” according to NHK World.
“It would be the first Japanese-made Covid shot available for practical use.”
Unfortunately, the article doesn’t give any details of the effectiveness the experts apparently confirmed.
Big Pharma companies have been scrambling to develop new Covid shots for the public, despite ethe pandemic being over.
Pharmaceutical companies have been working on a new type of RNA vaccine that will contain self-amplifying RNA (saRNA), a more potent form of the mRNA found in the Covid vaccines.
According to reports, several vaccine manufacturers have been developing the new saRNA injections that will likely be fast-tracked through regulatory hurdles.
From the Epoch Times:
Numerous preclinical and clinical studies applying saRNA technology have already been undertaken.
A 2023 review in the journal Pathogens touts saRNA vaccines as “improved mRNA vaccines.”
The journal Vaccines published a summary of five years of saRNA study findings.
Once the requisite clinical studies are finished, these new vaccines can be approved for use.
It can be expected that this process will be as quick as it was for the COVID-19 vaccines.
The approval process will become simpler, as it could be argued that the technique (modRNA in lipid nanoparticles) is already approved and that only the modRNA sequence is different.
“Hence, these new saRNA vaccines could be injected into an unsuspecting public at any time,” the Epoch Times notes.
“While BioNTech performed experiments with saRNA (BNT162c2) but finally focused on modRNA (BNT162b2), Arcturus Therapeutics was the first to announce (in 2022) that its COVID-19 saRNA vaccine candidate ARCT-154—now the most advanced saRNA vaccine in trials—meets the primary efficacy endpoint in a phase-3 study.
“In the Arcturus Therapeutics study, participants received two doses, each containing 5 micrograms of saRNA.
“This is far less than the modRNA concentrations used by Pfizer-BioNTech (30 micrograms/shot) and Moderna (100 micrograms/shot).”
saRNA presents a “political solution” to the problem of mRNA vaccines because it requires only a tiny amount of the substance to be reproduced by human cells after injection.
But that “political solution” is also the very reason why the saRNA injections should not be given to the public.
“Compared to modRNA, a small number of saRNA results in an increased amount of produced antigen,” according to the Epoch Times.
“The ‘dose’ of viral antigen that current and future RNA-based vaccines bring about will show large fluctuations from one individual to the next, depending on the cell type producing the desired antigen, genetic predisposition, medical history, and other factors.
“This fact alone should prohibit the use of RNA-based injections as vaccines for healthy people.”
Even more alarming is that Pfizer’s Covid shot that was administered to the public was formulaically different than the Covid shot used in its clinical trial.
This was a result of the manufacturing process that scaled up the vaccine for widespread use.
“This means that individuals who gave consent to be vaccinated were injected with a substance different from the one approved by regulatory agencies and to which they had consented,” Steger wrote.
In other words, the developmental clinical trial version of these new saRNA injections likely won’t be the same when they are eventually distributed to the public.
link
Frank Bergman
December 3, 2023 - 12:29 pm
Japan has just approved the first-ever “self-amplifying mRNA” Covid shot, despite having no safety or efficiency data.
“A Japanese Health Ministry panel has said a coronavirus vaccine developed by Daiichi Sankyo can be used for inoculations in Japan,” according to NHK World.
“It would be the first Japanese-made Covid shot available for practical use.”
Unfortunately, the article doesn’t give any details of the effectiveness the experts apparently confirmed.
Big Pharma companies have been scrambling to develop new Covid shots for the public, despite ethe pandemic being over.
Pharmaceutical companies have been working on a new type of RNA vaccine that will contain self-amplifying RNA (saRNA), a more potent form of the mRNA found in the Covid vaccines.
According to reports, several vaccine manufacturers have been developing the new saRNA injections that will likely be fast-tracked through regulatory hurdles.
From the Epoch Times:
Numerous preclinical and clinical studies applying saRNA technology have already been undertaken.
A 2023 review in the journal Pathogens touts saRNA vaccines as “improved mRNA vaccines.”
The journal Vaccines published a summary of five years of saRNA study findings.
Once the requisite clinical studies are finished, these new vaccines can be approved for use.
It can be expected that this process will be as quick as it was for the COVID-19 vaccines.
The approval process will become simpler, as it could be argued that the technique (modRNA in lipid nanoparticles) is already approved and that only the modRNA sequence is different.
“Hence, these new saRNA vaccines could be injected into an unsuspecting public at any time,” the Epoch Times notes.
“While BioNTech performed experiments with saRNA (BNT162c2) but finally focused on modRNA (BNT162b2), Arcturus Therapeutics was the first to announce (in 2022) that its COVID-19 saRNA vaccine candidate ARCT-154—now the most advanced saRNA vaccine in trials—meets the primary efficacy endpoint in a phase-3 study.
“In the Arcturus Therapeutics study, participants received two doses, each containing 5 micrograms of saRNA.
“This is far less than the modRNA concentrations used by Pfizer-BioNTech (30 micrograms/shot) and Moderna (100 micrograms/shot).”
saRNA presents a “political solution” to the problem of mRNA vaccines because it requires only a tiny amount of the substance to be reproduced by human cells after injection.
But that “political solution” is also the very reason why the saRNA injections should not be given to the public.
“Compared to modRNA, a small number of saRNA results in an increased amount of produced antigen,” according to the Epoch Times.
“The ‘dose’ of viral antigen that current and future RNA-based vaccines bring about will show large fluctuations from one individual to the next, depending on the cell type producing the desired antigen, genetic predisposition, medical history, and other factors.
“This fact alone should prohibit the use of RNA-based injections as vaccines for healthy people.”
Even more alarming is that Pfizer’s Covid shot that was administered to the public was formulaically different than the Covid shot used in its clinical trial.
This was a result of the manufacturing process that scaled up the vaccine for widespread use.
“This means that individuals who gave consent to be vaccinated were injected with a substance different from the one approved by regulatory agencies and to which they had consented,” Steger wrote.
In other words, the developmental clinical trial version of these new saRNA injections likely won’t be the same when they are eventually distributed to the public.
link
