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We collaborated with Tony's team for years, working on various vaccine candidates. After analyzing different antigens for MERS, we found that the full-length spike protein with mRNA was the most effective. When we received the SARS CoV 2 sequence on January 13, both teams independently recommended the same vaccine design. We immediately ordered production, leading to the start of phase 1 trials on March 16.

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.

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.

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.

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.

The goal is to stabilize the healthcare system and prevent crisis situations during pandemics. Vaccinating as many people as possible is crucial, and in the future, influenza vaccination could become routine for everyone. Eventually, a universal vaccine may be developed, reducing the need for frequent vaccinations. This would protect people from both seasonal and pandemic flu. This approach benefits both the public and vaccine companies, as they can predict that the majority of the American population will be vaccinated every year, eliminating uncertainty.

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.

We are working on developing new vaccines like TB and HIV using mRNA technology to make them high quality and low cost. Current COVID vaccines are not perfect, so we are working on new versions with longer-lasting protection for diseases like measles and tuberculosis. The mRNA technology also shows promise for cancer vaccines and rapid adaptation to future pandemics. We are even exploring using this technology for animal vaccines.

FluBlock utilizes insect cells for rapid manufacturing, representing innovative biotechnology. Traditional flu vaccines require adapting influenza strains to cell or egg cultures, potentially resulting in a vaccine antigen that differs from the circulating antigen. FluBlock, using baculovirus technology, can proceed directly from sequence to manufactured protein faster, eliminating the need for adaptation. This is a key advantage.

In 2017, Moderna published a paper on an influenza vaccine using lipid nanoparticles. The study showed that in animals tested, the lipid nanoparticle vaccine spread into the brain, bone marrow, liver, spleen, and the muscle site where it was injected.

Creating mRNA is easy, cheap, and scalable. In the next 5 years, we aim to improve stability and cost, allowing for global vaccine production. mRNA will be explored for diseases like HIV, malaria, and TB with various approaches. The Gates Foundation and other global health organizations will support mRNA vaccine development.

We designed an active protein for humans, focusing on vaccines first to manage risk. The scientific community is skeptical but on board with our platform's ability to produce vaccines quickly and efficiently. We believe mRNA vaccines will revolutionize the industry, offering high efficacy and safety profiles. The regulatory path for boosters involves smaller studies focused on neutralizing antibodies. We aim to boost the entire planet next year with mRNA vaccines, disrupting the traditional vaccine market and creating innovative products.

We ensure there is enough capacity and competition for vaccines, leading to lower prices and the development of new vaccines. This includes vaccines for TB, malaria, HIV, and even COVID-19. To improve vaccines, we aim for longer duration and broader coverage, and plan to replace needles with patches. The pandemic has shown that we have not invested enough in these innovations. Our partners in India play a crucial role in achieving these breakthrough products.

NIH is pursuing a universal vaccine designed to cover the entire range of viruses, aiming to mimic natural immunity. The developers claim it would be effective against any mutation and would not drive the virus to mutate. They expect the approach could work not only for coronaviruses but also for flu, offering broad protection. They describe the vaccine as safer and more effective than current options. The dialogue centers on ongoing questions as the project advances, emphasizing a shift toward a single, universal solution that could, if successful, provide cross-viral protection and reduce the need for virus-specific vaccines. The statements focus on safety, efficacy, and cross-coverage across coronaviruses and influenza.

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.

In the next 5 years, we can easily and inexpensively produce mRNA, which is the key to its success. We just need to work on improving the stability, cost, and scalability of lipid nanoparticles. Once we achieve that, we can establish factories worldwide to manufacture affordable vaccines within a short time frame. We plan to use mRNA technology for diseases like HIV, malaria, and tuberculosis, with different approaches for each. The Gates Foundation and other organizations focused on global health will support our efforts to develop these missing vaccines using mRNA.

Speaker 0: Extremely dangerous self amplifying replicon mRNA injections are currently being deployed for humans and animals across the globe. A few days ago, The UK approved Arcturus Therapeutics self amplifying COVID nineteen injection for adults over 18. Previously, the European Union approved the same Arcturus Therapeutics replicon injection for adults. So it's in The EU. It's in The UK. Japan approved it in 2023. So it's being injected into Japanese citizens as well as India. India has approved these replicon injections as well. And so it is being rolled out across the globe and here in The US is very worrisome. The USDA approved the self amplifying mRNA particle injections for our dogs and cats. This is Novavac NXT by Merck. And so that's actively being injected into our, our pets and probably shedding onto human owners across The United States as well in The US. Our FDA fast tracked an h five n one bird flu replicon injection trial, and we have to remember just how dangerous these are. So not only can they likely shed this replicating genetic material can shed onto other humans or from our pets to humans to the human owners, but they can also recombine with wild viruses and and create these chimeric mutants. But what's most important is this Arcturus Therapeutics injection being approved everywhere in the in the clinical trials for them. Eighty five percent suffered systemic adverse events, fifteen percent required medical attention. And then a recent study in Uganda, it induced severe blood abnormalities in ninety three percent of the recipients. They suffered from thrombocytopenia, lymphopenia, neutropenia. So their immune systems were being degraded, and they were suffering inter increased risks of internal bleeding in a majority of participants. And eighty five percent of them were vomiting, had high fevers, and felt absolutely terrible. So this self amplifying assault on humanity needs to come to an end. We have to pull these off of the market and ban them for human use.

We are working on developing new vaccines for diseases like TB, HIV using mRNA technology. The goal is to create high-quality, low-cost vaccines that can be used for various illnesses. Current COVID vaccines have limitations, so we are working on next-generation vaccines with longer-lasting protection. mRNA technology also shows promise for cancer vaccines and potential future pandemics. Additionally, we are exploring using this technology for animal vaccines.

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.

“And we will have new vaccines. We'll have a, TB vaccine, malaria vaccine, HIV vaccine, and even the things like COVID vaccines.” The speaker envisions vaccines for TB, malaria, HIV, and COVID, with longer duration and broader coverage. “We need to make them have longer duration, more coverage, and we're gonna change instead of using the needle to use a little patch.” The plan includes longer-lasting protection and a switch from needle injections to patch delivery. “So the pandemic really highlighted that we've been underinvested in those innovations, and, you know, our partners in India are are part of how we're gonna get these breakthrough products done.” The pandemic is cited as underscoring underinvestment, with India-based partners playing a role in bringing breakthrough products to fruition.

We only have one old and ineffective licensed vaccine for tuberculosis. To improve this, we aim to use the experience gained from developing effective platforms during the COVID-19 pandemic to create a new and effective tuberculosis vaccine. Today, we received unprecedented commitments from member states, partners, and donors to invest in this initiative. We believe that this new vaccine could be a game-changer. We are inspired and eager to support all stakeholders and work together with them to make this happen.

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.

New vaccines for tuberculosis, malaria, HIV, and COVID-19 are being developed. These vaccines aim to have longer-lasting effects and wider coverage. In addition, instead of using needles, a patch will be used for administration. The COVID-19 pandemic has brought attention to the fact that we have not invested enough in these innovative advancements.