Some of the Studies being undertaken.
These studies were brought to my attention by Ms. Lucinda van Buuren, the Chair of the steering committee for the World Council for Health (Australia).
The active trial sites are Australia, Costa Rica, Honduras and the Philippines.
The completed trial sites are the US, UK, South Africa, Vietnam and Singapore.
Safety, Reactogenicity, and Immunogenicity of a Self-Amplifying mRNA Influenza Vaccine trials in Healthy Adults
Chimpanzee Adenovirus and Self-Amplifying mRNA Prime-Boost Prophylactic
Vaccines Against SARS-CoV-2 in Healthy Adults
Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine
Administered With Influenza Vaccines in Adults
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza
Vaccine in Adults
Study of Self-Amplifying Messenger Ribonucleic Acid (samRNA) Vaccines Against
COVID-19 in Healthy Adults and People Living With Human Immunodeficiency
Virus (HIV)
Commentary
The development of self-amplifying mRNA (saRNA) vaccines has garnered significant interest as an innovative approach to immunisation. These vaccines offer the potential to produce a more robust response using a lower dose of mRNA, due to their ability to amplify antigen production within host cells.
Self-amplifying mRNA is a next-generation ‘vaccine’ platform that builds upon the principles of conventional mRNA ‘vaccines’. It contains replicase proteins derived from viruses, allowing the mRNA to replicate once inside cells. This amplification can enhance antigen expression, stimulating a stronger and more durable ‘immune’ response at lower doses compared to conventional mRNA ‘vaccines’ . The self-amplifying mRNA also avoids the need for live attenuated viruses or viral vectors, reducing concerns over viral vector-induced immunity or replication competency .
In a Phase 1 clinical trial conducted to assess the safety of a self-amplifying mRNA influenza vaccine in healthy adults, the vaccine was well tolerated at all dose levels tested. The participants were monitored for adverse events (AEs) after receiving different doses of the vaccine. The most common side effects included mild-to-moderate pain at the injection site, fatigue, and headache, which are similar to those observed with other mRNA vaccines. These symptoms generally resolved within 1–3 days.
No serious adverse events (SAEs) related to the vaccine were reported during the trial. Importantly, safety monitoring also included laboratory evaluations of blood markers, such as liver enzymes and inflammatory markers, to rule out systemic reactions or organ toxicity. None of the participants showed concerning changes in these markers .
While the trial showed an excellent safety profile, ongoing studies will continue to monitor the long-term safety of saRNA vaccines, particularly in larger and more diverse populations, to ensure comprehensive safety assessments.
Reactogenicity refers to the short-term inflammatory responses triggered by vaccines, which are often associated with transient symptoms such as swelling, pain, fever, and fatigue. In the Phase 1 trial, the reactogenicity of the saRNA influenza vaccine was consistent with expectations for mRNA-based vaccines . Most participants experienced mild-to-moderate local reactions, including erythema and swelling at the injection site.
Systemic reactogenicity was also assessed, with common complaints being fatigue, muscle aches, and headache. These reactions were reported more frequently at higher doses, but the majority resolved within a few days. Importantly, no participants required medical intervention for these symptoms, and no life-threatening events were observed .
One of the most critical aspects of vaccine development is its ability to provoke a ‘protective immune response.’ Immunogenicity measures the capacity of the vaccine to elicit a targeted immune reaction, typically through the generation of specific antibodies or T-cell responses.
The saRNA influenza vaccine demonstrated strong immunogenicity in the Phase 1 trial. The vaccine elicited robust antibody responses against the influenza virus in most participants, with a clear dose-response relationship: higher doses resulted in higher antibody titers . Even at lower doses, the vaccine achieved seroconversion in a significant proportion of participants, indicating that it could offer protection with minimal mRNA input.
Neutralizing antibodies, which are critical for blocking viral infection, were also induced at all dose levels. Importantly, these immune responses were durable, remaining elevated for at least several months post-vaccination. Additionally, T-cell responses specific to influenza antigens were detected, suggesting that the vaccine stimulates both arms of the adaptive immune system .
Self-amplifying mRNA offers several advantages over conventional mRNA vaccines. First, because the mRNA can amplify itself, lower doses are required to achieve similar or even superior immunogenicity compared to conventional mRNA vaccines. This could make vaccine production more cost-effective and accessible, especially in resource-limited settings . Additionally, the self-amplifying feature of saRNA vaccines may lead to more robust cellular immune responses, including CD8+ T-cell activation, which is crucial for clearing viral infections and offering long-term protection .
While the early results for saRNA influenza vaccines are promising, there are still several challenges to address. One potential concern is the reactogenicity observed at higher doses, which may be a result of the immune system reacting to the replicase proteins in addition to the influenza antigen. Future studies will need to optimize the vaccine formulation to balance safety and immunogenicity, especially for broader populations including older adults, children, and those with pre-existing conditions .
Further research is also needed to evaluate the vaccine's effectiveness against circulating strains of influenza, as well as its potential to offer cross-protection against different viral subtypes. Given the rapid mutation rates of influenza viruses, saRNA vaccines may offer flexibility in adapting to new strains, potentially improving upon the existing annual flu shot model .
Safety Issues.
Self-amplifying mRNA (saRNA) technology, while promising for its efficiency in vaccine development, raises several potential safety concerns. These risks need to be carefully evaluated as the technology moves through clinical trials and broader use. Below are some of the key potential dangers associated with saRNA:
1. Enhanced Reactogenicity
Because saRNA encodes not only the antigen but also replicase enzymes to amplify the RNA within the host cells, there is a risk of enhanced reactogenicity. These replicase proteins can trigger stronger immune responses, leading to more frequent or severe local and systemic side effects. Common symptoms, such as fever, fatigue, muscle aches, and injection site inflammation, may be more pronounced in saRNA vaccines compared to conventional mRNA vaccines. Severe inflammatory responses, while ‘rare’, could pose a risk, particularly at higher doses.
2. Uncontrolled RNA Replication
Self-amplifying mRNA contains sequences that allow it to replicate within the host cells, theoretically amplifying the production of the target antigen. However, this process raises concerns about uncontrolled or excessive replication, which could lead to prolonged or excessive antigen production. This might increase the likelihood of adverse events, including exaggerated immune responses, tissue damage, or chronic inflammation.
3. Autoimmunity
As with other types of vaccines, there is a risk that saRNA vaccines could trigger autoimmune reactions. If the immune system mistakes self-proteins for foreign antigens, it could lead to an attack on the body’s own cells. This risk could be heightened if the replicase or antigen encoded by the saRNA shares structural similarities with human proteins, potentially leading to molecular mimicry and autoimmune diseases like Guillain-Barré syndrome or lupus.
4. RNA Persistence and Long-Term Effects
Conventional mRNA degrades ‘relatively quickly’ after it enters the cell, but with saRNA, the replication process may prolong the presence of the RNA. This raises concerns about the long-term presence of foreign RNA in the body and its potential effects. Although no evidence has suggested persistent RNA could integrate into the genome (since mRNA doesn't typically interact with DNA), the longer lifespan of saRNA in cells might carry unknown risks over time. Prolonged expression of the antigen might overstimulate the immune system, leading to chronic inflammation or autoimmunity.
5. Off-Target Effects
Self-amplifying mRNA vaccines are designed to target specific cells for antigen production, but there is a risk that the vaccine may unintentionally affect non-target tissues. If the vaccine ends up being taken up by cells in unintended tissues, this could result in aberrant protein expression, potentially causing organ-specific damage or dysfunction. For instance, off-target effects in the liver or heart could lead to unintended toxicities in those organs.
6. Immunogenicity of Replicase Proteins
One potential issue with saRNA is that the replicase proteins themselves may be immunogenic. In other words, the immune system might generate a response against these proteins, which could result in unwanted side effects or reduced effectiveness of the vaccine. If the body mounts an immune response against the replicase enzymes, it could interfere with the amplification process and reduce the overall antigen production, limiting the vaccine’s efficacy. Moreover, the immune response to replicase might cause systemic inflammation or other immune-related complications.
7. Cytotoxicity
High levels of antigen expression driven by self-amplifying mRNA could overwhelm cellular machinery, leading to cytotoxicity. If cells produce too much of the target protein, they may experience stress, potentially leading to cell death or apoptosis. This could be particularly concerning if high antigen loads occur in vital tissues, potentially causing damage.
8. Genetic Interference and Unintended Immune Responses
There is some concern about how saRNA could interfere with other genetic processes within the cell. While mRNA itself does not integrate into the host genome, the large amounts of RNA and resulting protein could interfere with cellular processes or disrupt normal gene regulation. Furthermore, the presence of foreign RNA in the cytoplasm could trigger the innate immune system via RNA sensors, leading to inflammation and, in some cases, the activation of pathways that inhibit normal protein synthesis.
9. Long-Term Immunological Effects
Since saRNA can produce more antigen over a longer period than conventional mRNA vaccines, there is uncertainty about the long-term impact on the immune system. Chronic exposure to antigens might lead to immune tolerance, where the body becomes less responsive to the antigen over time. Alternatively, prolonged stimulation could lead to an overstimulated immune system, which could contribute to chronic inflammation or autoimmune conditions in some individuals.
10. Environmental and Ecological Risks
If saRNA technology becomes widely used, there are also potential ecological concerns, particularly in the context of mass vaccination. The large-scale production and disposal of saRNA vaccines may pose risks if these molecules are accidentally released into the environment. There is a concern about the stability of synthetic mRNA outside the body and its potential interaction with environmental RNA or DNA. Furthermore, there could be ethical or safety concerns related to the widespread use of saRNA in animals, which might have ecological implications if not properly regulated.
Self-amplifying mRNA technology holds great potential for enhancing vaccine efficacy and broadening the range of vaccine applications. However, it also introduces unique risks related to uncontrolled amplification, prolonged antigen expression, and possible off-target effects. As this technology advances, rigorous long-term safety studies and careful monitoring of its effects in diverse populations will be essential to mitigate these potential dangers.
Future research should focus on optimizing saRNA vaccines to balance their amplification capabilities with safety, ensuring that the benefits of increased immunogenicity do not come at the expense of safety. Further studies on dosage, delivery mechanisms, and long-term safety will help address these concerns as the field progresses.
The wise alternative is to completely abandon this foolish research and give everyone nutritional advice and vitamin D (C and Zinc). Cheap, available and truly safe and effective.
Please see my Substack on Lethal Synergism before deciding to have any more RNA vaccines.
Ian Brighthope
I'll be 71 in a few days (https://jonfleetwood.substack.com/p/repeated-mrna-covid-jabs-lead-to?). Yesterday morning, while opening Gmail, I was offered the following vaccines by my local hospital staff: - Covid - Influenza - VRS (Virus respiratoire syncytial) The government had never done such a thing before this eternal state of pandemic we're in now. I'm known here for my 'wrong thinking' and for wholeheartedly adhering to anti-vax misinformation theories (no, I just try to stay alive as long as I can), so my Social worker in the senior citizens' program sent me this email: "I think I already know your answer, but I have to ask if you would like vaccines administered at home." We're at a stage where the people paid to look after our well-being hound us with dangerous intentions. Social workers act like the desperate 'kapos' of the former German camps of WWII. That's unfortunate but real.
So when do the vaccines know when to stop "self-amplifying", crazy, stay away from this poison people. As Dr Brighthope says, vitamin C and other health measures does a better job. I have had my 2 cups of lemon water, 2 cups of celery juice, a small bowl of watermelon and now just had 2 apples and a kiwi fruit. Eating a lot of fruit has also kept my 87 year old mum healthy, she just had all blood test results with no issues showing. She sits in the sunshine most days too. Sun does not cause skin cancer but lack of sun does, especially if you plaster your body with toxic sunscreen cream/spray.