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Dr. Hotez explains that while vaccines are often described as miraculous, the development was not a four-month process but a seventeen-year effort dating back to the post-SARS period. After SARS emerged in 2003, researchers identified the spike protein as the virus’s soft underbelly and began experimental vaccine development. When the COVID-19 sequence was released in January, the coronavirus community quickly concluded that a vaccine could be made, and attention turned to which technology would be fastest and most enduring. All vaccines discussed (AstraZeneca, Pfizer, Moderna, J&J, and the one being scaled in India) target the spike protein. He emphasizes that this was a deliberate long-term program, not a rushed push. Nicole notes the broader context of vaccine safety, particularly on a day when a vaccine-skeptical witness testified before the Senate Homeland Security Committee. Dr. Hotez clarifies that the virus behind the current pandemic comes from a family of coronaviruses scientists have studied for a long time, and that once specifics emerged, researchers could finalize the vaccine approach. He reiterates the importance of reassurance about safety in light of public skepticism. Dr. Hotez highlights the role of the NIH and the National Institute of Allergy and Infectious Diseases, led by Tony Fauci, and Francis Collins at NIH, in launching a major coronavirus program beginning in 2003. This funding enabled the development of some of the first prototype vaccines, illustrating a deliberate US government and NIH investment to advance vaccine research. He notes the ongoing need to assess rollout and production robustness, as this technology is brand new, and additional vaccines will be necessary to vaccinate populations. Looking ahead, the conversation acknowledges that the United States will require four or five different vaccines to achieve broad vaccination coverage, rather than relying solely on the two mRNA vaccines. The UK has begun vaccinations, marking an initial step, with plans to scale in the United States in the coming days. The discussion underscores a long road ahead to ensure scalable production, distribution, and multiple vaccine options to meet demand.

Vaccines are seen as magical but expectations should be tempered. Pfizer's vaccine is 95% effective, but efficacy drops over time. Boosters may be needed annually. Moderna is working on a combined flu and COVID vaccine. The future is uncertain, but we must adapt.

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.

Now that we're coming out of the pandemic, the issue of variants will mainly be discussed by specialists. They will talk about the impact of these variants in conferences. Currently, the planned vaccination covers all variants. And does vaccination limit the emergence of new variants? Absolutely, by reducing the number of affected individuals. It decreases the portion of the population where the virus can multiply and mutate, thus leading to new variants. So, vaccination is absolutely essential to control the situation.

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.

Over the past few weeks, BARDA reviewed 22 mRNA vaccine development investments and began canceling them. 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. That's because a single mutation can make mRNA vaccines ineffective. 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. 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.

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 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.

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.

Vaccines are seen as magical, but expectations may need to be lowered. Pfizer's vaccine is 95% effective, but efficacy rates can fluctuate. Protection may only last a year, requiring annual shots. Moderna is working on a combined flu and COVID vaccine. The future is uncertain, but there is hope for improvement in the next 5 years.

Robert F. Kennedy Jr., as HHS secretary, explains that BARDA is canceling 22 mRNA vaccine development investments, primarily for flu and COVID. He claims mRNA vaccines don't perform well against upper respiratory viruses because they only code for a small part of viral proteins, and a single mutation can make them ineffective. This drives antigenic shift, paradoxically encouraging new mutations and prolonging pandemics. HHS has determined that mRNA technology poses more risk than benefits for these viruses. The canceled contracts total just under $500 million. HHS will prioritize safer, broader vaccine strategies like whole virus vaccines and novel platforms that don't collapse when viruses mutate. HHS supports safe, effective vaccines and is moving beyond the limitations of mRNA for respiratory viruses.

Robert F. Kennedy Jr. states that HHS, via BARDA, is canceling 22 mRNA vaccine development investments, mostly for flu and COVID. He claims mRNA vaccines don't perform well against viruses infecting the upper respiratory tract because mRNA only codes for a small part of viral proteins, and one mutation can make the vaccine ineffective. Kennedy alleges this drives antigenic shift, where vaccines encourage mutations and prolong pandemics as viruses mutate to escape the vaccine's protection. HHS has determined that mRNA technology poses more risk than benefits for these respiratory viruses. The canceled contracts total just under $500,000,000. HHS is prioritizing safer, broader vaccine strategies like whole virus vaccines and novel platforms that don't collapse when viruses mutate. HHS supports safe, effective vaccines but is moving beyond the limitations of mRNA for respiratory viruses.

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.

Robert F. Kennedy Jr. states that HHS, via BARDA, is canceling 22 mRNA vaccine development investments, mostly for flu and COVID, because mRNA vaccines don't perform well against upper respiratory viruses. mRNA only codes for a small part of viral proteins, and one mutation can make the vaccine ineffective, driving antigenic shift, which encourages new mutations and prolongs pandemics. Millions caught Omicron despite being vaccinated, demonstrating this. HHS determined mRNA technology poses more risk than benefit for respiratory viruses after consulting experts at NIH and FDA. BARDA is terminating contracts totaling just under $500 million. HHS is prioritizing safer, broader vaccine strategies like whole virus vaccines and novel platforms that don't collapse when viruses mutate. HHS supports safe, effective vaccines but is moving beyond the limitations of mRNA for respiratory viruses.

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.

- The mRNA vaccines, you know, from COVID don't work against upper respiratory infections. - There are two problems with them. - One is they target a single protein, which drives what what's called an antigenic shift. - If it drives the virus to mutate, and it actually can prolong the pandemic. - And we saw that during COVID, people took shots, mRNA shots for the original COVID variant and immediately, mutated into the Omicron virus to which the vaccine was ineffective, and that's what it does. - And the other issue is, that it the way that distributes in the body, the way that it migrates in the body, there's no control over and no predictability. - So it goes to every organ.

Developing a vaccine is crucial to controlling the pandemic. Normally, it takes about five years to create a new vaccine, including testing for safety and effectiveness. However, efforts are being made to compress this timeline to around 18 months. The RNA platform shows promise in speeding up production. Ensuring a vaccine's effectiveness and safety, especially for older individuals, is challenging. We must avoid compromising safety while increasing efficacy. Decision-making regarding the use of a new vaccine will be based on limited data to expedite progress. Supporting the development of the most promising candidates, building production facilities, and conducting safety testing require a global collaborative effort. Our foundation is heavily involved in funding vaccines, including for developing countries. It's encouraging to see various medications emerging, such as Moderna, CureVac, Stamovi, and Logovac, which require investment.

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.

“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'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.