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    • Making Progress in Developing a COVID-19 VaccineSignificant progress is being made in developing a COVID-19 vaccine with over 200 programs, compressed timeline of 12-18 months, mRNA technology showing promise, transparency, equitable distribution, and addressing potential risks are crucial.

      We are making significant progress in developing a vaccine for COVID-19, with over 200 programs in development across various organizations. The usual vaccine development timeline of 10-15 years is being compressed down to 12-18 months through accelerated processes and systems. Modern technologies, such as mRNA vaccines, are being applied for the first time and have shown promising results. The conversation also touched on the importance of transparency, equitable distribution, and addressing potential risks and impacts on different populations. The interview with Rajeev Venkayya, a vaccine development expert, provided valuable insights into the current state of vaccine development and the challenges that lie ahead. Overall, the development of a COVID-19 vaccine is a complex process that requires collaboration and innovation from various players, and it's crucial to stay informed and engaged in the conversation.

    • Rapid development of COVID-19 vaccine using novel mRNA technologyMRNA technology allows for quick identification and production of candidate vaccines, revolutionizing the vaccine development process, with Moderna developing a COVID-19 candidate vaccine in just 40 days.

      The development of a vaccine against SARS CoV 2 is happening much faster than usual due to the use of novel technologies like mRNA vaccines. Traditional vaccine development involves discovering a virus in the lab, testing it on animals, moving to human trials, and finally, large-scale production. With mRNA vaccines, researchers can identify the virus and produce a candidate vaccine rapidly by inputting the sequence of the proteins that are most likely to trigger an immune response. Although mRNA vaccines have been around for some time, they have never been used to create a licensed vaccine. Moderna famously developed a candidate COVID-19 vaccine in just 40 days, and this demonstrates the potential of these new platforms to revolutionize the vaccine development process. However, it's important to note that no mRNA vaccine against COVID-19 is currently licensed. The use of these novel technologies, along with the urgency of the pandemic, is driving the rapid progress towards a vaccine.

    • Record-breaking speed of COVID-19 vaccine developmentDespite potential risks of shortened timeline for long-term safety and efficacy data, large clinical trials ensure vaccine safety and transparency is key for public understanding.

      The ongoing development and distribution of COVID-19 vaccines, specifically the mRNA vaccine from Moderna, is happening at an unprecedented speed due to parallel processes in clinical trials and manufacturing. This compression of timeline from 10-12 years to 12-18 months comes with some risks, including the lack of long-term data on vaccine safety and efficacy, such as the duration of protection and potential rare side effects that may only appear years after vaccination. However, the size of clinical trials remains the same to ensure safety and efficacy, and transparency is crucial for sharing data and ongoing safety information with the public. While some vaccine-related complications have occurred in the past, most are rare, and it's essential to provide a complete understanding of the vaccine's efficacy and safety profile to the public.

    • Maintaining Public Trust in COVID-19 VaccinesTransparency from companies, regulators, and governments before and after vaccine launch is crucial to address concerns and ensure acceptance, mitigating potential vaccine denialism.

      As the world races to develop COVID-19 vaccines, maintaining public trust in their safety and efficacy is crucial. The emergence of "neo-anti-vaxxers," who are hesitant due to lack of information, adds to the challenge. While some concerns are based on misinformation, others are legitimate, such as the rapid development timeline and the need for long-term safety data. To address these concerns, transparency from biopharmaceutical companies, regulatory authorities, and governments is essential before vaccines are licensed. Post-launch, ongoing transparency about data collection and long-term safety profiles is necessary. Despite the small likelihood of significant safety concerns emerging, addressing these concerns proactively is vital to ensure vaccine acceptance and mitigate potential vaccine denialism.

    • A world of customizable vaccinesExpect multiple COVID-19 vaccines with varying attributes, expert recommendations based on population needs, and quick response to emerging threats through on-demand vaccine creation using mRNA technology

      We can expect multiple COVID-19 vaccines with varying attributes, and expert bodies will recommend the best options based on population needs, efficacy, safety, and duration of protection. The development of mRNA technology allows for the potential creation of vaccines on demand as new threats emerge, moving us towards a world where we can quickly respond to diseases X and other unexpected viruses. The goal is to have safe and effective vaccines that cater to specific populations, including older adults and pregnant women, and address the pandemic as efficiently as possible. This platform approach, which some call "plug and play," holds great promise for protecting against emerging threats and potentially evading vaccine-resistant viruses.

    • Challenges in Developing Effective Vaccines Against New AgentsScaling up production to large quantities with high quality, determining vaccine durability, and assessing efficacy are major challenges in developing new vaccines. Newer platforms like mRNA offer improvements but have their own bottlenecks.

      The development of effective vaccines against new agents like COVID-19 is a promising hope, but there are significant challenges to overcome, such as scaling up production to large quantities with high quality, determining the durability of protection, and assessing the level of efficacy. Vaccine production is a complex process, and while traditional methods like growing vaccines in eggs have their advantages, newer platforms like mRNA offer marked improvements in terms of predictability and control. However, the scale-up process from small to large-scale production is a major bottleneck. The technological infrastructure developed for COVID-19 vaccine production will provide a significant vote of confidence for future pandemic preparedness, but it may not be a one-size-fits-all solution for all viruses. The digital version of the virus spreading around the world faster than the biological one is a remarkable achievement that accelerated the response to the pandemic.

    • Renaissance in Vaccinology due to COVID-19The pandemic has accelerated vaccine development, introduced new platforms and adjuvants, and shown the importance of creating vaccines for coronaviruses and influenza, leading to increased investment and market changes.

      The COVID-19 pandemic has accelerated advancements in vaccinology, leading to a renaissance in the field. New platforms, adjuvants, and more efficient methods for vaccine development are being evaluated, making it faster and less risky to create vaccines. The pandemic has also shown that coronaviruses and influenza are likely causes of future pandemics, making the development of vaccines for these viruses crucial. Additionally, the market for vaccines is expected to change, with more government and philanthropic funding to reduce risk and new business models for companies. The memory of the crisis and its impact may be longer than previous crises, leading to sustained investment in vaccines.

    • Opportunities for Biotech Startups in the Global Health CrisisDespite challenges, biotech startups can make an impact in antivirals, diagnostics, and vaccines. Innovative ideas, funding, and smarter regulatory approaches can lead to significant commercial opportunities and public health benefits.

      The current global health crisis presents both challenges and opportunities for businesses in the biotech industry, particularly in the areas of antivirals, diagnostics, and vaccines. While these areas are complex and often dominated by incumbents, there is still room for emerging startups with innovative ideas. For instance, developing a low-cost, home-based diagnostic test for viruses could have a significant impact on disease transmission and commercial opportunities beyond the pandemic. Startups should also consider seeking funding from various sources, including philanthropic organizations, to help get their ideas off the ground. Regarding the regulatory landscape, while some of the economic risks and urgencies of the pandemic may subside in the future, the safety and efficacy standards for vaccines must not be compromised. However, smarter risk-based approaches and less capital-intensive methods could lead to faster vaccine development in the future. As for the timeline, it is uncertain when a vaccine for the current pandemic will be available, but there is optimism that progress is being made. It is important to remain vigilant and adaptable to the ever-evolving landscape of the biotech industry and the global health crisis.

    • Vaccines focusing on spike protein for immunityEarly data from various vaccine types suggest they generate neutralizing antibodies and T cell response, reducing the risk of disease enhancement, while focusing on the spike protein could provide broad coverage against future virus evolutions.

      The majority of vaccine programs are focusing on the spike protein of the virus, specifically the receptor binding domain, to elicit an immune response. While this is the most likely approach to provide protection, there's a theoretical risk that other parts of the virus may be necessary for complete immunity. The good news is that early data from various vaccine types, such as messenger RNA, vector, and recombinant, suggest the generation of neutralizing antibodies and a T cell response, which is important for long-term protection. However, there's a theoretical risk of antibody-mediated disease enhancement, where non-neutralizing antibodies could worsen the disease upon exposure to the virus. A vaccine that elicits a T helper cell 1 response is less likely to result in this phenomenon. While it's too early to predict the long-term effectiveness and durability of the vaccines, it's possible that focusing on the spike protein could provide broad coverage against future evolutions of the virus, as mutations in this protein could reduce the virus's ability to enter cells and replicate effectively. However, it's essential to remain vigilant for potential mutations that could evade vaccine protection.

    • Discussions continue on vaccine prioritization, but healthcare workers and vulnerable populations are expected to be first in line.Discussions on vaccine prioritization are ongoing, with healthcare workers and vulnerable populations likely to receive the vaccine first. Schools should not wait for a vaccine to reopen, and the US government's Warp Speed initiative has contributed significantly to vaccine development, benefiting the global community.

      While we may have a good sense of the ability of vaccines to protect against COVID-19 by the end of this year, it is likely that meaningful quantities of vaccine will not be available until early to middle of next year. The prioritization of who gets the vaccine first is still under discussion, but healthcare workers and vulnerable populations are expected to be at the top of the list. Schools should not wait for a vaccine to reopen, as they are essential for the development and well-being of children. The US government has made significant contributions to vaccine development through the Warp Speed initiative, and while they have not contributed financially to making vaccines available for other countries, the data generated from these trials will benefit the global community.

    • Two factors for school safety: community transmission and in-school measuresControlling community transmission and implementing safety measures within schools are crucial for ensuring safe reopening during the pandemic. Global collaboration through the COVAX financing facility can help ensure equitable vaccine distribution.

      The safety of reopening schools during the COVID-19 pandemic depends on two main factors: the level of community transmission and the measures taken within the schools to prevent transmission. Controlling community transmission is crucial for making schools safer, as it reduces the likelihood of the virus entering the school environment. Within schools, measures such as reducing classroom density, requiring masks and physical distancing, and cohorting students can help minimize transmission risk. The equitable distribution of COVID-19 vaccines is another pressing issue, as there will not be enough vaccines for everyone in the beginning. To address this challenge, organizations like the WHO, CEPI, and Gavi have collaborated to create the COVAX financing facility, which aims to ensure global equitable access to vaccines by pooling resources and entering into contingent contracts with vaccine developers. This approach can help ensure that both developing and higher income countries receive vaccines, providing a more equitable distribution of resources during this unprecedented global crisis.

    • Healthcare and policy lessons from COVID-19The pandemic underscores the importance of early, coordinated action, less sensitive rapid tests, and a layered approach to virus transmission reduction. Investing in public health capacity and evidence-based decision-making are crucial for effective policy responses.

      The ongoing COVID-19 pandemic has presented numerous surprises and challenges for both healthcare practitioners and policymakers. From a healthcare perspective, the assumption of a single national response and the need for early, coordinated action to limit virus transmission have been major lessons learned. Additionally, the value of less sensitive, rapid diagnostic tests in a public health context has emerged as an effective strategy for identifying and quarantining cases. However, no single intervention is foolproof, and a layered approach combining interventions like masks, physical distancing, and quarantining is necessary for effective virus transmission reduction. From a policy standpoint, the pandemic has highlighted the importance of investing in public health capacity and the value of evidence-based, data-driven decision-making. Despite the challenges, the successful implementation of these interventions could set the stage for future public health crises and access to medicines.

    • A multifaceted approach to fighting the virusBehavioral changes and technology, like masks, social distancing, better diagnostics, and vaccines, are crucial for protecting ourselves and the planet during the pandemic.

      Just as multiple factors contribute to safety in a vehicle accident, from driver education to traffic rules and seat belts, the fight against the virus also requires a multifaceted approach. Behavioral changes, such as wearing masks and social distancing, are crucial, but technology, like better diagnostics and vaccines, will also play a significant role. We're on the brink of a vaccine renaissance, and the implications for protecting ourselves and the planet are a silver lining in these challenging times. Ultimately, it's the combination of these interventions that will help us save lives, reduce illnesses, and weather the storm until we reach the ultimate goal of a safe and effective vaccine.

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    PA Education Programs Prepare Students for Expanding Roles - Jonathan Bowser, Director of the Child Health Associate/Physician Assistant Program at the University of Colorado Denver

    PA Education Programs Prepare Students for Expanding Roles - Jonathan Bowser, Director of the Child Health Associate/Physician Assistant Program at the University of Colorado Denver

    Physician Assistant remains one of the fastest growing professions in the US, and the expansion of their role in healthcare delivery seems to be growing just as quickly. One of the biggest changes in that regard, according to Jonathan Bowser of the University of Colorado Denver School of Medicine, is that states are opening up opportunities for PAs to practice with more autonomy to fill needs in the healthcare system. “That requires PA education programs to think about who are we putting out there, what environments they are going into, and how do we best prepare them for those environments,” says Bowser, who runs the school’s Child Health Associate/Physician Assistant Program (CHAPA), one of the oldest PA training programs in the country. The need to adapt their program to these new realities and the desire to take advantage of advances in learning science led CHAPA to overhaul its curriculum in recent years. The result is a ‘spiral curriculum’ - an iterative approach to learning that reinforces key concepts and knowledge as students progress through their years of training.  Join host Hillary Acer as she learns about the underpinnings of CHAPA’s curricular approach, what the program is doing to prepare PAs to be leaders and the growing importance of residencies and fellowships to prepare PAs to work in clinical specialties. 

    Mentioned in this episode: 

    CHA/PA Program Overview

    Managing Transitions by William Bridges

    Make It Stick by Peter Brown

    The Role of Philanthropy in Innovation: Dr. Bennett Nemser, Chief Program Officer at the Steven & Alexandra Cohen Foundation

    The Role of Philanthropy in Innovation: Dr. Bennett Nemser, Chief Program Officer at the Steven & Alexandra Cohen Foundation

    “I think philanthropy’s role oftentimes is to come in and be the innovator,” says Dr. Bennett Nemser who is in a good position to do that as chief program officer at the Steven & Alexandra Cohen Foundation managing its health portfolios. Perhaps the best example of this is its involvement in psychedelic research where the Foundation is one of the largest private funders in the country including being a major backer of the Center for Psychedelic and Consciousness Research at Johns Hopkins Medicine. While he is excited about the progress being made in that space, Nemser says the Foundation is intent on ensuring equitable access to any new therapies that emerge, one of the organization’s chief overall aims. “We need to get the price point down so that we can make sure we have access to a lot more people that can benefit from this.” As Nemser tells Raise the Line host Shiv Gaglani, the Foundation is seeking to have similar impact in other critical areas. “We’ve provided over a billion dollars in charitable support to underserved communities, children's health and education, the arts, Lyme and tick-borne disease, psychedelics, veterans services and sustainability.” Don’t miss this expansive look at philanthropy’s change-making potential.

    Mentioned in this episode: https://www.steveandalex.org/