The Vax Files

Nearly two years after Covid-19 was first detected in Wuhan, the world is still very much in a pandemic. The toughest phase may behind us, but we are still faced with the possibility of new variants of concern, waning immunity and vaccine evasion. As first-generation vaccines start to show their weaknesses, next-generation vaccines are becoming more and more important. While hundreds of vaccines are in the pipeline, there are a few frontrunners and other interesting candidates that might be meaningful additions to our Covid vaccine armamentarium. Experts discuss the current status of a number of protein-based vaccines including candidates from Novavax, Vaxine, Clover, GSK/Sanofi and others. DNA vaccines are also still an attraction with the first authorization for Zydus Cadila in India. Other mRNA vaccines might offer meaningful differentiation, while vaccines targeting the S and N protein might also have greater importance when it comes to tackling future variants. While nasal and oral vaccines seem appealing for the prevention of infection and transmission, they also have some inevitable hurdles to overcome and are still a long way off materializing. Experts discuss future manufacturing hurdles that will require greater global collaboration to achieve future vaccine production and distribution goals. Finally, experts discuss the current global status so far and forecasts for exiting the pandemic state and entering a livable endemic. 

Expert Guests:

-- Reynald Castaneda is the Clinical Trials Editor of GlobalData Media in London, covering drug development for investors and the pharmaceutical industry.

-- Dr Maria Elena Bottazzi is the Associate Dean, National School of Tropical Medicine and Professor of Pediatrics (Tropical Medicine) and Molecular Virology and Microbiology at Baylor College of Medicine, Texas, US. She is a leading expert in vaccine development and tropical diseaes.

-- Dr Deborah Fuller is a Professor of Microbiology at The University of Washington School of Medicine. A veteran vaccinologist and researcher, she has been working on vaccine development for the last 30 years with specific research around DNA and RNA technologies. 

-- Dr Shabir Madhi is Dean of the Faculty of Health Sciences and Professor of Vaccinology at the University of the Witwatersrand, Johannesburg, South Africa. He is also the co-founder of the African Leadership Initiative for Vaccinology Expertise (ALIVE).

-- Dr Nikolai Petrovsky is Professor of Medicine, Flinders University, Adelaide, Australia and vice-president and secretary-general of the International Immunomics Society. He is the founder of vaccine biotech, Vaxine, which has a protein based vaccine for Covid-19 in its pipeline.

-- Dr Monica Gandhi is Professor of Medicine and Associate Division Chief (Clinical Operations/Education) of the Division of HIV, Infectious Diseases, and Global Medicine at University California San Francisco/San Francisco General Hospital.

-- Dr Prashant Yadav is a Senior Fellow at the Center for Global Development and Affiliate Professor of Technology and Operations Management at INSEAD. Yadav has with governments and global organizations to improve medical product supply chains. Previous roles include Strategy Leader-Supply Chain at the Bill & Melinda Gates Foundation and Chair of the Market Dynamics Advisory Group of the Global Fund.

-- Dr. Nadia Sam-Agudu is Associate Professor of Pediatrics (Immunology/Infectious Diseases) at the University of Maryland School of Medicine and Senior Technical Advisor at the Institute of Human Virology Nigeria. She conducts public health and implementation research in maternal and child health, with a focus on HIV and other major infectious diseases in African countries.

As the world tries to take a hold over the delta variant, we're all watching and waiting to see if the virus is going to evolve into something new. There are fears that natural selection could potentially yield a new variant that will completely escape all of our current vaccines. While these scenarios are hypothetical, experts discuss the need to be vigilant and prepared without unnecessary panic. Experts unpack the virus' evolution so far into delta and how that has impacted our goals for herd immunity. They talk about the possibilty for delta to change into a variant more transmissible or virulent, and how potentially leaky vaccines might impact or enhance the virus' evolutionary path. In August, Joe Rogan highlighted a paper on his podcast "The Joe Rogan Experience," which raised public concern that our current vaccines are potentially encouraging new potent variants to emerge. The author of that paper, Professor Andrew Read, comes on to clarify his research in chickens and where certain extrapolations can and can't be made. Meanwhile, experts discuss the possibility of vaccine pressure and the need for new vaccines and which types of vaccine development strategies might better help us get ahead of the virus' curve. 

As governments around the world try to get their countries and economies back on track, they are starting to desperately implement a number of vaccine policies that have sometimes been questioned by society and scientists. In this episode, experts discuss the rationale around boosters, who should get them, when they are the most effective and the problems around offering third doses to individuals when many vulnerable people around the globe are still fighting for their first. Experts also talk about mandates and the debate around forcing the previously infected to be fully immunized when the data suggests otherwise. They also discuss possible mandates for children and schools, vaccine passports to live general life and cross borders as well as different countries discriminating against which vaccines are acceptable for a passport. Finally, experts talk about whether it makes scientific sense to implement such strict mandates at this stage of the pandemic given the shifting understanding around how these vaccines are actually working among communities. With the current problem of global vaccine inequity, experts question whether such mandates implemented by rich countries are ethical and fair.

Vaccination in children has fueled a global expert debate specifically around the risk benefit consideration that some may find acceptable and others may find questionable. While children were largely protected from the virus early on in the pandemic, we've come to a point where children are getting sick, some of them severely ill and dying. Experts discuss the changing risks of Covid in kids and how the benefits of vaccination in kids measure up versus potential adverse events. We first look at inactivated vaccines, which are now the most used vaccines in children (as young as 2 years of age) and we take a special deep dive into Chile's rationale for its large scale vaccination drive to get kids back into school. mRNA vaccines are also starting to get rolled out with Pfizer just receiving a US authorization in kids aged 5-11, and experts discuss the risk benefits and greater unknowns of this new technology, particularly around the nuance of dosing, Experts discuss the overall rationale for vaccination when looking at efficacy, safety and potential mechanistic concerns. Vaccinating kids and its overall impact on this pandemic remains debated, although perhaps not in Africa, where children may be the most at need of vaccination to reach global herd immunity, yet stand to be at the end of the queue. Meanwhile, as the issue around pregnancy continues to generate vaccine hesitancy, experts discuss new available data that speaks to the the risk/benefit profile in pregnant women and women wanting to conceive.

Expert Guests

With around 7 billion doses administered, the vaccines have largely been proven safe, but there are still major concerns around rare serious side-effects and long term safety unknowns. Experts discuss how safety events have been picked up via public reporting systems -- which have been both a help and a hindrance for the safety discussion -- and how they are being further analyzed. Experts breakdown real world data and the occurrence of rare serious adverse events including VITT (with the adenoviral vector vaccines) and myocarditis (with the mRNA vaccines). While the newer modalities have led to a few surprise fatalities, the inactivated viral vaccines remain clear of fatal serious events and experts discuss what risk ratio is generally acceptable in a deadly pandemic. Experts also discuss extreme safety alarm being perpetuated by social media, particularly the claim that vaccines are killing more people than they are saving. They stress the need for better public communication and education, whilst it is important to vet public sources that may be overdramatizing certain risks by promoting flawed analyses.

Since the last episode in February, a lot has happened with the vaccination rollout -- so we're back for a few more episodes. But we've changed our name from The CoVax Files to The Vax Files, which was was done mainly to avoid any confusion with GAVI/WHO's COVAX facility and also to maintain our independence from any official organization.

In this final and tenth episode, we'll tackle some of the last lingering questions that we all have around the vaccines and how the future might look as we navigate these uncharted pandemic waters. Experts first discuss new interim datasets from Johnson and Johnson and Novavax, notably their results on preventing severe disease, hospitalizations and deaths, and how they might fit into the vaccine paradigm. We'll break down why some EU countries have made the surprise recent decision not to administer AstraZeneca's vaccine to people over 65. Meanwhile, Russia's Sputnik-V now has a lot more data and we'll see how this vaccine measures up on the global scale of vaccines. Experts discuss vaccine utility in the real world and the debate around infection and transmission, delaying the second dose to get first doses out quicker and mixing different vaccine brands under extenuating circumstances. Safety remains a big question as the media and social media continue to flag individual cases of severe side-effects and deaths, but we'll look at the data and statistics and how to critically think about the overall safety profile of the vaccine (and when not to panic). Finally, this episode will tackle important future questions such as the need to vaccinate children and how things might look as we attempt to get back to being a global community with travel.

In this ninth episode, we'll tackle the different conundrums we face with the emergence of new and highly transmissible SARS-COV-2 variants. Get ready to delve into some thought provoking scientific concepts when it comes to how this virus appears to be evolving and where we stand with our current and future vaccination goals. The episode parses out the most worrisome mutations, how they were able to evolve and why they are such a concern. Experts talk about recent data from Johnson & Johnson and Novavax, which are tell tale signs of the issues we have ahead. They also discuss where our currently authorized vaccines - Pfizer, Moderna, AstraZeneca -- stand to combat the new variants. We'll explore what manufactures are doing to keep up with new mutations and the various challenges in chasing a moving target. While experts agree that this will probably not be a once in a lifetime vaccination, they make comparisons to seasonal influenza and remain debated on how often we might need to revaccinate. Finally, experts discuss the best approach forward with both the vaccines and prudent social behaviors to ensure that we don't lose this pandemic battle due to complacency.

In this eighth episode, The Covax Files takes a mini world tour on some mass vaccinations programs that started in December 2020 and January 2021.  Surani speaks to experts in different regions to get a taste of what has been happening on the ground with rollouts in the US, Europe, Israel and India, and the unique strengths and challenges within each region. While the US is facing issues with simply getting vaccinations sites set up to deliver a huge supply of vaccines to patients, the EU is facing the opposite problem with a mobilization plan in place but not enough vaccine to go around. Israel has become the unforeseen world leader of vaccinations after signing a unique data-sharing deal with Pfizer, while India also surprises with some grand plans to not only take care of its 1.3 billion population, but also its neighboring countries. Many countries, especially lower income countries are yet to receive a single vaccine dose, and experts discuss the global distribution challenges that are brought on when rich countries sign private deals to buy doses directly from pharma companies. This episode explores the COVAX facility and how it's set up to ensure equitable access of vaccines across the globe and the broader challenges to counter vaccine nationalism.

Expert Guests:

-- Professor Hani S. Mahmassani is Director at the Northwestern University Transportation Center and William A. Patterson Distinguished Chair in Transportation. He specializes in multimodal transportation systems analysis, large-scale human infrastructure systems, and real-time operation of logistics and distribution systems.

-- Neeraj Jain, MBA, is the director of PATH’s India operations -- an organization dedicated to health equity and part of the COVAX initiative. He oversees all operations in the country and serves as a liaison between the office in India, PATH headquarters, donors, partners, and national-level ministries.

-- Stefan Walzer is the CEO and founder of MArS market access and pricing strategy, based in Germany. Stefan has more than 15 years experience in payer strategy, pricing, health economics and reimbursement submissions.

-- Julia Barnes-Weise is Executive Director of the Global Healthcare Innovation Alliance Accelerator. She is also a Senior Consultant to the Coalition for Epidemic Preparedness and Innovation (CEPI) and has been a Consultant to the WHO. 

In this seventh episode, experts discuss how the vaccine gets from the manufacturers gate into a patient’s arm and all the challenges in between. The episode looks at how transportation and storage has been planned and executed by the big international transportation players thus far. While there have been some pleasant surprises with smooth deliveries in some western countries, getting the vaccine to lower income countries will remain an ongoing challenge. Freezer storage capacity — both during transportation and at vaccination sites — will be a crucial consideration and this will only get more challenging as more vaccines get authorized and distributed. Meanwhile, with a very short planning process ahead of rollout, experts discuss the greater potential for human error when trying to keep the limited vaccine supply viable. Finally, experts discuss the need for better planning and investment around scheduling vaccine administrations, which has been the biggest unexpected hurdle thus far, particularly in the US.

Expert Guests:

-- Dr Prashant Yadav is a Senior Fellow at the Center for Global Development and Affiliate Professor of Technology and Operations Management at INSEAD. Yadav has with governments and global organizations to improve medical product supply chains. Previous roles include Strategy Leader-Supply Chain at the Bill & Melinda Gates Foundation and Chair of the Market Dynamics Advisory Group of the Global Fund.

-- Professor Hani S. Mahmassani is Director at the Northwestern University Transportation Center and William A. Patterson Distinguished Chair in Transportation. He specializes in multimodal transportation systems analysis, large-scale human infrastructure systems, and real-time operation of logistics and distribution systems.

-- Dr Gregory Gray is a Professor at Duke University and infectious disease epidemiologist with three affiliations: Duke Global Health Institute, Division of Infectious Diseases, and Duke Nicholas School of Environment. He was on the FDA advisory committee for vaccines and related biologics between 2010-2013.