5 Deaths Already Recorded in EudraVigilance For The Self-Amplifying mRNA-based COVID-19 vaccine
ARCT-154, Kostaive, Zapomeran
This is all fluffy stuff for the Kool-Aid drinkers but this is what Grok says:
Self-amplifying RNA (saRNA) vaccines are an advanced type of mRNA vaccine designed to enhance immune responses with lower doses compared to traditional mRNA vaccines. Unlike conventional mRNA vaccines, which deliver a fixed amount of mRNA that instructs cells to produce a specific antigen (like a viral protein), saRNA vaccines include an additional component: genetic instructions for an RNA-dependent RNA polymerase derived from alphaviruses, such as Venezuelan equine encephalitis virus (VEEV). This enzyme enables the saRNA to replicate itself inside host cells, amplifying the production of the antigen-encoding mRNA and leading to higher and more sustained protein expression.
Key Features of saRNA Vaccines:
Self-Replication: saRNA contains two open reading frames—one coding for the antigen (e.g., SARS-CoV-2 spike protein) and another for the replicase enzyme. Once inside the cell, the replicase amplifies the mRNA, resulting in more antigen production from a smaller initial dose.
Lower Dosage: Due to self-amplification, saRNA vaccines require significantly less RNA (e.g., 5 µg for ARCT-154 vs. 30–100 µg for conventional mRNA vaccines like Pfizer or Moderna). This reduces production costs and logistical challenges.
Prolonged Expression: saRNA sustains antigen production for longer (up to 1–2 months), potentially offering more durable immune responses.
Delivery: Like mRNA vaccines, saRNA is typically encapsulated in lipid nanoparticles (LNPs) to protect the RNA and facilitate cell entry. Other delivery systems, such as cationic nanoemulsions, are also being explored.
Applications and Development:
COVID-19: The first fully approved saRNA vaccine, ARCT-154 (developed by Arcturus Therapeutics and CSL), targets SARS-CoV-2 and was authorized in Japan in November 2023 for adults as a primary or booster vaccine. It encodes the spike protein and has shown strong neutralizing antibody responses at low doses (5 µg). Another saRNA vaccine, Gemcovac-19, received emergency use authorization in India in June 2022.
Other Diseases: saRNA vaccines are being researched for influenza, rabies, Zika, Ebola, and malaria. For example, GSK’s rabies saRNA vaccine (RG SAM) is in clinical trials, and preclinical studies have shown protection against Ebola in mice.
Therapeutic Potential: Beyond infectious diseases, saRNA is being explored for cancer immunotherapy and genetic disorders due to its ability to sustain protein expression.
Advantages:
Rapid Development: Like mRNA vaccines, saRNA can be quickly designed and produced, ideal for emerging pathogens.
Cost-Effective: Lower doses mean higher manufacturing volumes and reduced costs, improving access in low-resource regions.
Strong Immune Response: saRNA induces both humoral (antibody) and cellular (T-cell) immunity, often with a Th1-biased response, and may provide broader protection against viral variants.
Thermostability: Some saRNA formulations, like ARCT-154, are stable at room temperature when lyophilized, easing storage and distribution compared to mRNA vaccines requiring ultracold storage.
Challenges and Concerns:
Delivery: The larger size of saRNA (~10,000 nucleotides vs. ~2,000 for mRNA) makes efficient delivery into cells more complex, requiring optimized LNPs or other systems.
Innate Immune Response: saRNA can trigger strong interferon responses, which may cause side effects or reduce efficacy. Recent advances allow incorporation of modified nucleosides (e.g., 5-methylcytosine) to mitigate this, though compatibility with replication remains a challenge.
Safety: While preclinical and early clinical trials (e.g., COVAC1 in the UK) show saRNA is generally safe, long-term safety data is limited. Concerns include potential cellular stress or apoptosis due to prolonged RNA replication.
Public Perception: Posts on X have raised alarms about saRNA, with some users speculating it could be “contagious” or a “bioweapon” due to its self-replicating nature. These claims are unfounded, as saRNA lacks viral structural proteins and cannot produce infectious particles. However, such sentiments reflect public skepticism that could impact acceptance.
Current Status:
Approved Vaccines: ARCT-154 (Japan, EU) and Gemcovac-19 (India) are the only fully or emergency-authorized saRNA vaccines, both for COVID-19.
Clinical Trials: Ongoing trials include GSK’s rabies vaccine and saRNA candidates for influenza and other viruses. Phase I trials (e.g., COVAC1, VLPCOV-01) have demonstrated immunogenicity at low doses, though some variability in seroconversion rates suggests need for optimization.
Research: Companies like BioNTech, Pfizer, and Novartis are investing in saRNA, with preclinical studies exploring trans-amplifying systems (where replicase and antigen are on separate RNAs) to improve versatility.
Critical Perspective:
While saRNA vaccines offer significant advantages in potency and scalability, the technology is still maturing. The self-replicating mechanism raises theoretical concerns about uncontrolled RNA amplification, though current designs mitigate this by excluding viral structural proteins. Limited long-term safety data and the complexity of managing innate immune responses warrant cautious optimism. Public distrust, fueled by misinformation on platforms like X, underscores the need for transparent communication about saRNA’s mechanisms and safety profile.
For more details on specific vaccines like ARCT-154, visit Japan’s Ministry of Health website (https://www.mhlw.go.jp) or Arcturus Therapeutics’ updates (https://www.arcturusrx.com). For pricing or availability, check with local health authorities, as I lack specific data on these.
Here some Hulscher comments:
REMINDER - Self-Amplifying (Replicon) mRNA Injections Are Actively Being Deployed Worldwide
APR 2025 - U.S. FDA fast tracks Gates & BARDA- funded self-amplifying mRNA bird flu injection (Arcturus Therapeutics - ARCT - 2304)
FEB 2025 - EU approves COVID-19 samRNA injection (Arcturus Therapeutics - ARCT-154)
NOV 2024 - U.S. FDA authorizes trial for H5N1 bird flu samRNA injection (Arcturus Therapeutics - ARCT - 2304)
NOV 2023 - Japan fully approves COVID-19 samRNA injection (Arcturus Therapeutics - ARCT-154)
JUNE 2022 - India authorizes very first COVID-19 samRNA injection for human use (Gennova Biopharmaceuticals - GEMCOVAC-19) There are currently at least 33 replicon mRNA injection candidates in development. It's become abundantly clear that the pharmaceutical industry and captured regulatory agencies have zero regard for the massive safety concerns of undefined synthetic mRNA replication resulting in uncontrolled toxic antigen production.
Here’s vaersaware.com receipts:
As of Today May 31, 2025, 5 deaths already recorded out of 14 total reports in EudraVigilance aka the EMA’s database:
For those not familiar with EudraV’s format it looks like this
Anybody frisky enough to dive into the EMA website, look here:
Below are the 5 death reports:
What's the point of saying there are vaccine trials? There's none. The manufacturers said there's none. No blind placebo trials at all. There are 5 deaths here. There are 1223 deaths in the first 3 months I. Pfizer's Cumulative Analysis Report February 28, 2021. So what ? No one cares? They want us dead. There's 150 more injections in development for us to take. I wish they'd stop pretending that this is for our own good on the basis that the injection will " crisper "out some rare rare form of genetic disease and it will save one person , maybe, somewhere in the world. Anyone today that is willing to inject themselves or their children with a government injection has to be out of their minds. 🇨🇦
For anyone who doesn't want to go to the trouble of opening up the five pdf's: Four of the deaths were over 85 years old, one was 65-85. One of the over 85's looks like she died immediately. The others took 1 day, 4 days, 5 days. When will this madness end?