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In Chicago, Medicago uses plants as bioreactors to grow vaccines. They insert virus gene sequences into Agrobacterium tumphatians bacteria, which is then absorbed by the plants. After a few days in a greenhouse, the plants start producing virus-like particles, the key component of the vaccines.

mRNA vaccines code for a small part of viral proteins, usually a single antigen. A single mutation can make the vaccine ineffective. This drives antigenic shift, where the vaccine encourages new mutations, prolonging pandemics as the virus mutates to escape the vaccine's protection. Millions caught the Omicron variant despite vaccination because a single mutation can render mRNA vaccines ineffective. The same risk applies to the flu.

In the event of a future pandemic, waiting a year for a vaccine is undesirable. AI has the potential to shorten this timeline to just a month, which would be a significant advancement for humanity.

The FDA is considering simplifying COVID vaccinations to one shot annually, similar to the flu shot. Researchers are also developing an mRNA flu vaccine, leveraging technology used in COVID vaccines. Traditional vaccines introduce weakened germs, while mRNA vaccines teach cells to produce proteins that trigger immune responses. This new flu vaccine could be adjusted more easily for different strains during flu season. Although the mRNA flu vaccine may not be superior to traditional ones, it offers an alternative for those who cannot tolerate existing vaccines. Current studies on mRNA vaccines are also exploring options for Lyme disease, rabies, HIV, and Zika, with results for the flu vaccine expected by March.

Chicago's manufacturing facility is using a unique technology called virus like particles to grow vaccines. Medicago, the company behind this process, uses plants as mini bioreactors. They start by synthesizing the virus code into a biological product using the gene sequence. The code is inserted into bacteria called Agrobacterium tungfaciens, which is then submerged with the plants in a bacterial bath. The plants absorb the information and continue growing in a controlled greenhouse for at least 4 days. During this time, they start producing virus like particles, which are the crucial ingredient for the vaccines.

You don't need a secret lab or a massive complex to create bioweapons. Unlike nuclear weapons, biological weapons can be developed discreetly, blending in with legitimate activities like vaccine production. This dual-use nature makes it difficult to detect a biological weapons program.

In Chicago's manufacturing facility, a new type of vaccine is being developed using a technology called virus like particles. Medicago, the company behind it, uses plants as mini bioreactors. They start by synthesizing the gene sequence of a virus into a biological product. The plants absorb this information through a bath with bacteria, which is then replaced with liquid using a vacuum. After spending at least 4 days in a controlled greenhouse, the plants begin producing virus like particles, the key ingredient for the vaccines.

The speakers discuss the need for a new and improved method of vaccine production. They acknowledge the challenges of transitioning from the current egg-growing process to a more efficient method. The process of proving the effectiveness of a new vaccine and going through clinical trials can take up to a decade. They suggest the need for a disruptive entity that is not bound by bureaucratic processes to address the problem of influenza. They also mention the possibility of using RNA sequences from novel avian viruses in China to create vaccines that can be self-administered through patches.

The NIH is developing a universal vaccine that addresses the entire phylum of viruses. This vaccine mimics natural immunity and is effective against any kind of mutation. It doesn't drive the virus to mutate. The researchers believe it could be effective not only against coronaviruses but also against influenza. The vaccine is described as much safer and much more effective. The exchange then notes that Mark, did you take your question again? and Mark is prompted to ask his question.

The symposium revolves around the science and safety implications of Replicating/Replicon vaccines and broader RNA vaccine platforms, with a sequence of expert presentations and reactions from the panel. -荒川博 presents the central premise that Replicon vaccines (replicating or self-amplifying RNA vaccines) raise unique safety and biosafety concerns beyond traditional mRNA vaccines. He frames the discussion around the idea that these vaccines “increase and mutate” within the host, potentially evolving in ways that could affect humans and populations. He references specific real-world events and case observations, including severe vascular events and tissue damage in some vaccine recipients, as motivation to scrutinize this technology carefully. -荒川 emphasizes that Replicon vaccines differ from conventional mRNA vaccines by embedding replicative machinery so that the RNA self-amplifies inside cells. He explains that, unlike ordinary mRNA vaccines, replication can produce more copies of the RNA and additional viral proteins, potentially leading to unexpected immune and biological consequences. He notes that the Alpha virus replicase used in some designs is designed to enable replication and increased antigen production, but that high mutation and recombination potential could yield variants or new properties. -藤本、藤田（参加者は複数） and others discuss the science of replication in viruses, highlighting the Central Dogma nuances. They describe that normally DNA → RNA → protein is the standard flow, but some viruses (RNA viruses and certain retroviruses) can reverse or bypass parts of this flow (RNA to DNA in retroviruses; RNA to RNA replication in some RNA viruses). This provides a conceptual basis for why replicating vaccines could, in principle, generate abnormal replication dynamics or new variants. -コロナウイルスRNAワクチンの議論では、Repliconの増殖と変異率の高さ、組換えの可能性、体内拡散の可能性を挙げて、「増えると変わる」性質が人の体内でどう影響するかが核心テーマとして挙げられます。アルファウイルス由来のレプリカーゼを使う場合、修復機能が不完全なRNAの増殖過程で、予想外の抗原変異を引き起こすリスクがあるとの指摘が出てきます。 -リスクの具体例として、ウイルスの殻（エンベロープ）とエクソソームを介した分布、自己拡散型ワクチンによる体内の遺伝子素材の取り込み、さらには他の人へ感染・伝播するアウトブレークの可能性、という仮説的懸念が提示されます。レプリコンワクチンは「空の遺伝子を抗原遺伝子に置き換えた陰性空間を持つウイルス」という説明が繰り返され、組換え・遺伝子交換・逆転など、従来のDNA・RNA動態の外に出る事象が起こり得ると議論されます。 -一部のスピーカーは、日本での試験・臨床・規制の動きを取り上げ、FDA/国内基準値を超えるDNA混入、SV40プロモーター混入の報告など、製品レベルでの懸念を指摘します。ケビン・マッカーシー氏の分析紹介では、日本市場で使われているファイザー社のコロナワクチンにDNA混入の痕跡があったこと、SV40プロモーター混入の可能性が指摘され、脂質ナノ粒子を通じた細胞内へのDNA／エクソンの取り込みリスクが懸念事項として挙げられます。これにより、RNAワクチンのフォーマットが終わるのではなく、プラットフォーム自体が拡大・進化する過程で新たなリスクを生む可能性を示唆します。 -IGG4関連疾患の急増とコロナワクチンの関連を例示する報告を紹介。IGG-4抗体が高値となり、多様な臓器炎症を引き起こす病態が観察され、ウイルス感染・ワクチン接種と免疫抑制・過剰免疫の連携が臨床で見られるケースの存在が議論されました。これにより、免疫の過剰反応・異常免疫を招く可能性があるとの懸念が示唆されました。 -ウイルス学・免疫学の専門家は、Repliconワクチンの「増殖・変異・組換えの三拍子」が、長期的・広範な公衆衛生影響をもたらし得る点を強調します。従来のウイルスワクチンの枠組みを超え、自己拡散・他者伝播・遺伝子汚染の可能性を定量的に評価する必要があると主張します。 -議論は、Repliconの潜在的リスクと実利を天秤にかけるもので、現時点で「安全」と断定できないという結論に至る場面が多くありました。実臨床での結果を長期観察で検証し、エビデンスに基づく判断を求める声が複数の speaker から出ました。 -最後に、メディア・一般市民への啓蒙の喚起と、透明性の高い情報提供、そして次世代ワクチン開発の安全性を担保するための厳格な規制・評価の重要性が強調されました。現状の科学的理解には限界があり、今後も公衆衛生への影響を見据えた厳密な検証が不可欠であるとの結論が共有されました。 overall, the event centers on the scientific basis, potential risks, and regulatory considerations of Replicon vaccines, contrasted with traditional mRNA vaccines, with emphasis on mutation, recombination, potential horizontal spread, DNA contamination concerns, immune dysregulation (including IGG4-associated phenomena), and the need for rigorous, transparent evaluation before broad deployment.

Chicago's manufacturing facility is using a unique method called virus like particle technology to grow vaccines. Medicago, the company behind this process, starts by synthesizing the gene sequence of a virus into a biological product. They insert this code into bacteria, which then carries it into plant cells. The plants absorb the code and begin producing virus like particles, the key ingredient of the vaccines. After a four-day growth period in a controlled greenhouse, the plants are ready for vaccine production.

Researchers at McMaster University are developing a needle-free, inhaled COVID-19 vaccine called AeroVax, a mucosal vaccine administered directly into the lungs to generate a targeted immune response. Phase one is complete, and phase two is recruiting participants. The vaccine is viral vector-based, using the adenovirus with spliced genes from the COVID virus, but contains no live COVID. It includes three COVID virus antigens, intended to produce a more robust and broader immune response, including t-cells, b-cells, and an innate immune response. The innate immune system may offer protection against other viruses and variants. Administered via a specialized inhaler, the vaccine uses particles tiny enough to reach deep into the lung. The dosage is about 100 times less than injectable vaccines, reducing manufacturing costs. Inhalation is believed to be more effective and addresses needle hesitancy. Researchers hope to bring the inhaled vaccine to market in the next five years.

We can't just shut down our current vaccine system and immediately switch everyone to a new, untested vaccine. To move beyond traditional egg-based vaccine production, which has served us well, we need a demonstrably superior alternative. This requires extensive clinical trials, potentially taking a decade even under ideal circumstances. Perhaps we need a disruptive entity, free from bureaucratic constraints. It’s difficult to alter perceptions of influenza unless we address the problem disruptively and iteratively from within. Imagine if a novel avian virus emerged in China, we could obtain its RNA sequence and transmit it to regional or even local centers, possibly even directly to homes, to print vaccines on patches for self-administration.

Today, we began a phase one trial on a nanoparticle that uses multiple different hemagglutinins, which are showing great promise. Our goal is to improve flu vaccines by creating a broadly protective influenza vaccine using a computationally designed nanoparticle platform. These nanoparticles display the virus protein repetitively, which triggers a strong immune response. We also discovered that our nanoparticle platform can display multiple hemagglutinins on the same particle, resulting in broader immune responses. In addition to protecting against current seasonal influenza strains, our vaccine also showed protection against H5N1 bird flu and H7N9. This project was done in collaboration with researchers at the NIH's vaccine research center. This is what our nanoparticle mosaic approach towards a universal flu vaccine looks like.

Chicago's manufacturing facility is using a technology called virus like particles to grow a new type of vaccine. Medicago, the company behind this process, uses plants as mini bioreactors. They start by obtaining the gene sequence of a virus and insert it into bacteria called Egerobacterium tumfaciens. The plants are then submerged in a bath with the bacteria, allowing the genetic information to be absorbed by the plant cells. The air between the plant cells is replaced with liquid using a vacuum. After the plants' bacterial bath, they are returned to a controlled greenhouse.

Japan has approved the world's first self-amplifying mRNA vaccine, developed by Meiji Seika Pharma. The vaccine, called Kasevi, uses self-amplifying mRNA technology, which is different from the mRNA vaccines by Pfizer and Moderna. The traditional mRNA vaccines contain modified mRNA that instructs cells to produce spike proteins, while the self-amplifying mRNA vaccines integrate genes for spike proteins and replicase, allowing the RNA to replicate itself inside cells. This leads to increased production of spike proteins and potentially more antibodies. The self-amplifying mRNA technology requires less RNA to be injected, potentially reducing side effects.

I've been involved in over 50 vaccines, including mRNA vaccines. mRNA is like DNA, giving cells instructions to make proteins. This technology was originally for gene therapy, now used for vaccines. It's a new, experimental technology never used in humans before COVID. Animal studies were skipped for COVID vaccines, a novel approach.

Robert F. Kennedy Jr.: Hi, it's Robert F. Kennedy Jr. here, your HHS secretary. At HHS, we have a division called the Biomedical Advanced Research and Development Authority, or BARDA. BARDA drives some of our most advanced scientific research. It funds developments of vaccines, drugs, diagnostics, and other tools to fight emerging diseases and national health threats. Over the past few weeks, BARDA reviewed 22 mRNA vaccine development investments and began canceling them. Let me explain why. Most of these shots are for flu or COVID, but as the pandemic showed us, mRNA vaccines don't perform well against viruses that infect the upper respiratory tract. Here's the problem: mRNA only codes for a small part of the viral proteins, usually a single antigen. One mutation and the vaccine becomes ineffective. This dynamic drives a phenomena called antigenic shift, meaning that the vaccine paradoxically encourages new mutations and can actually prolong pandemics as the virus constantly mutates to escape the protective effects of the vaccine. Millions of people, maybe even you or someone you know, caught the omicron variant despite being vaccinated. That's because a single mutation can make mRNA vaccines ineffective. The same risk applies to flu. After reviewing the science and consulting top experts at NIH and FDA, HHS has determined that mRNA technology poses more risk than benefits for these respiratory viruses. That's why after extensive review, BARDA has begun the process of terminating these 22 contracts totaling just under $500,000,000 To replace the troubled mRNA programs, we're prioritizing the development of the safer, broader vaccine strategies, like whole virus vaccines and novel platforms that don't collapse when viruses mutate. Let me be absolutely clear: HHS supports safe, effective vaccines for every American who wants them. That's why we're moving beyond the limitations of mRNA for respiratory viruses and investing in better solutions. Thank you. Produced by the U. S. Department of Health and Human Services.

We discussed pandemic readiness with Tony, proposing a mock outbreak to test fast vaccine production. Despite skepticism, we aimed to deliver a GMP dose within 60 days. When news of a new coronavirus emerged, we quickly recognized the need for action. Transitioning from traditional egg-based vaccine production to new methods requires disruptive innovation. The urgency for a faster, disruptive approach to address outbreaks is evident. The potential for rapid response to novel viruses by sharing RNA sequences globally is crucial. Investigation into motives for outbreaks is essential.

We are in a digital and scientific revolution, hacking the software of life with mRNA. Our body is made of organs, organs of cells, and in each cell is messenger RNA transmitting DNA information to proteins. This "operating system" can be altered to impact diseases like the flu and cancer. For instance, instead of injecting virus proteins for a flu vaccine, mRNA instructions can teach the body to make its own protection. This mRNA technology has vast potential for disease prevention and treatment.

The company Biontech in Mainz is working on a new method for producing vaccines. They use mRNA, a natural molecule found in every cell, to stimulate the body to produce the antidote itself. This personalized approach allows them to create a vaccine in just two to four weeks, making it possible to respond quickly to pandemics. The new vaccine is currently undergoing clinical trials, and if successful, it could be approved within five to six years. This breakthrough method could revolutionize the fight against time. However, it remains to be seen which of these new developments will come out on top once all the studies are completed.

The panel discusses replication (replicon) vaccines and their potential dangers, focusing on how they differ from conventional messenger RNA (mRNA) vaccines and what new risks might emerge as this technology develops. Key points and concerns raised - Replicon vaccines concept and fundamental differences - Replicon vaccines use replication-capable genetic material, so the embedded genetic information not only makes antigen proteins but also multiplies inside the cell. They are described as having both constitutive function (the ability to make proteins) and, crucially, the capacity to replicate, which distinguishes them from traditional, non-replicating mRNA vaccines. - It is explained that replication introduces additional mutation and recombination opportunities, because the RNA genome is copied more than once, and the process can produce variants that differ from the original design. - Central dogma exceptions and viral biology - The speakers explain that while the central dogma (DNA → RNA → protein) generally governs biology, some viruses violate this, with RNA viruses that replicate via RNA-dependent replication and even some reverse-transcribing retroviruses that convert RNA to DNA and integrate into genomes. This context is used to frame why replicon vaccines could behave unpredictably. - Potential risks of replication and spread - A core concern is that the replicon approach might allow the vaccine genome to spread beyond the initial target cells, potentially reaching other cells and tissues, or even spreading to other people via exosomes or other means. Exosomes can transport DNA, RNA, and proteins between cells; thus, the replicon genome could in theory be disseminated. - The possibility of homologous or heterologous recombination between replicon genomes and wild-type viruses could yield new variants. The panel emphasizes the difficulty of controlling such recombination in a living system. - Specific material and design considerations - The use of viral components like spike protein genes in replicon vaccines raises concerns about how these proteins might mutate or recombine during replication, potentially altering antigen presentation or safety. - A concern is raised about the lack of repair mechanisms in RNA replication (as opposed to DNA replication), which could make error rates higher and lead to unpredictable changes. - The panel notes that current replicon vaccine designs (including those using alphavirus backbones) inherently carry high mutation and recombination risk, and that the replicating systems may encounter unpredictable evolutionary dynamics inside the human body. - Safety signals and clinical anecdotes - The speakers cite cases of adverse events temporally associated with vaccines, including vascular inflammation and thrombosis, stroke-like events, and myocarditis, to illustrate that immune responses to vaccines can be complex and occasionally severe. They emphasize that such observations do not establish causality, but argue they warrant careful scrutiny. - There are references to cases of acute vascular and neural complications following repeated vaccination, and to broader immune dysregulation phenomena, including IGG4-related disease and immune dysregulation syndromes that can involve multiple organs. - One example concerns a patient who developed sudden limb problems after the third dose, requiring surgery; another describes myocardial involvement after multiple doses and subsequent inflammatory sequelae. - DNA contamination and analytical findings - Kevin McKernan’s analysis of certain Japanese CoronaVac vaccines is cited: both DNA contamination and the presence of SV40 promoter elements were detected in some vaccine lots, with DNA amounts exceeding some regulatory benchmarks in at least one case. The concern is that DNA contamination, or the presence of promoter sequences, could influence integration or expression in unintended ways. - It is noted that vaccines using lipid nanoparticles can potentially deliver nucleic acids into cells; in the presence of exons or promoter sequences, there could be unintended cellular uptake and expression. - Implications for public health and policy - The panel underscores the need for caution, thorough investigation, and long-term observation of any replication-based vaccine platform before broad deployment. There is a call to evaluate risks, monitor long-term outcomes, and consider the possibility that replication-competent constructs could drive unforeseen evolutionary dynamics within hosts or communities. - There is contention about how information is communicated to the public, with particular emphasis on avoiding misinformation while ensuring that scientific uncertainties are transparently discussed. - Broader scientific context and forward-looking stance - The speakers discuss how the field’s approach to gene-based vaccines is evolving rapidly, and they stress that the compatibility of replicon systems with human biology is not yet fully understood. - They frame their discussion as not merely about current vaccines but about the trajectory of vaccine platforms: if replication-based or self-dispersing systems prove too risky or unpredictable, the prudent path might be to favor conventional, non-replicating strategies until safety, efficacy, and containment of unintended spread are more firmly established. Closing and takeaways - The session closes with emphasis on careful evaluation of replicon vaccines, awareness that viral genetics can behave differently in humans than in theory, and a call for continued discussion, independent verification, and transparent communication as the technology develops. - Throughout, speakers acknowledge the complexity of immune responses to vaccines, the potential for unexpected adverse events, and the importance of safeguarding public health while advancing vaccine science.

Moderna and BioNTech used the first sequence of the SARS CoV-2 genome, published on January 10th, to develop their vaccines. Moderna relied solely on the published data and never had the live virus on their site. This highlights the significance of digitizing biology, as Moderna, a leading company in biology, faced a software problem rather than a biological one.

We're discussing the urgent need for a better flu vaccine that can protect against all types of influenza viruses. To tackle this challenge, we require passionate and talented individuals from diverse backgrounds to collaborate. By combining unconventional thinking, we can find faster solutions. Unlike measles, which remains consistent over time, influenza constantly changes due to mutations. This means that a new vaccine is needed each year to match the circulating virus. Occasionally, there are major changes in the virus caused by mutations or when it jumps species, resulting in a unique situation. Other viral infections like polio, smallpox, and measles do not exhibit this level of variability.

We discussed pandemic readiness with Tony, proposing a rapid response simulation. Despite skepticism, we aimed to produce a GMP dose within 60 days. In December, upon learning of the new coronavirus, we swiftly obtained its sequence. Transitioning from egg-based vaccine production to a more efficient method requires extensive testing and could take a decade. An innovative, disruptive approach may be necessary to address future outbreaks effectively. The potential for a quick response to novel viruses, like avian strains in China, highlights the need for agile solutions.