The Vax Files

In this sixth episode, experts discuss how vaccine development complexities often boil down to the manufacturing process and scaling up to large quantities. We take a look at how manufacturing processes are set up including the use of contract manufacturers (CMOs or CDMOs) that are largely in control of different parts of the production line. Experts also discuss the various pros and cons for the different manufacturing processes of mRNA vaccines, adenoviral vector vaccines, protein subunit vaccines and inactivated vaccines, and where bottle necks and supply delays could potentially form if stakeholders are not on their game. Ancillary material like vials and syringes will also be an important consideration when supply and demand is still unclear given that a lot of promising vaccines are not yet authorized. At the end of the day, nothing is impossible in this world filled with experienced industry players, but cooperation and collaboration might be the ultimate secret ingredient to success.

-- Dr Michael Kurilla is the Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, US National Institute of Health. He has been a member of the advisory committee for vaccines and related biologics since 2018.

-- Dr Craig Laferriere is a consultant on vaccine design and manufacturing with over 25 years experience in vaccine manufacturing, design and licensing. He is the head of vaccine development at Novateur and has previously worked on vaccine development for GlaxoSmithKline and Pfizer.

-- 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.

-- Fiona Barry is the associate editor of PharmSource, a trade publication that exclusively covers the pharmaceutical manufacturing industry.

This fifth episode takes a look at some of the next vaccines in the development pipeline that could be equally important when it comes to ending the pandemic with a selection of different vaccines. We’ll look at some of the challenges to continue ongoing clinical trials now that vaccines are already publicly available. Experts discuss GSK and Sanofi’s recombinant protein vaccine that had some disappointing interim results in December, and they also discuss why Australia's now abandoned vaccine was triggering false positives for HIV. We also take a quick glimpse at the inactivated vaccines coming out of China, and the future potential of DNA vaccines that use special devices. Finally we take a look further down the road to whether developing and manufacturing Covid-19 vaccines might be economically viable for smaller players in the race in the long term.

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

-- Dr Yves Van Laethem is a retired virologist from Centre Hospitalier Universitaire Saint-Pierre and is currently the spokesperson for the fight against coronavirus in Belgium.
-- Dr Sam Sun is a resident physician at the Baylor College of Medicine and Director of InDemic, a non-profit research tool providing expert knowledge and analytics on the management of the Covid-19 pandemic.

-- 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.

Adenoviral vector vaccines are seen as the vaccine for the world given that they are cheaper to produce and easier to distribute versus mRNA vaccines. We learn about their development in the lab and challenges that have been overcome, while experts discuss possible roadblocks of pre-existing immunity that may impact future efficacy. While AstraZeneca's confusing interim results get dissected, experts look ahead to results from Johnson & Johnson's single shot vaccine, which could be a pandemic game changer if successful. Finally, experts discuss the safety of these vaccines especially after both AstraZeneca and Johnson & Johnson’s trials had to be paused for safety last year.

-- Dr Yves Van Laethem is a retired virologist from Centre Hospitalier Universitaire Saint-Pierre and is currently the spokesperson for the fight against coronavirus in Belgium.

-- 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 Craig Laferriere is a consultant on vaccine design and manufacturing with over 25 years experience in vaccine manufacturing, design and licensing. He is the head of vaccine development at Novateur and has previously worked on vaccine development for GlaxoSmithKline and Pfizer.

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

-- Dr Sam Sun is a resident physician at the Baylor College of Medicine and Director of InDemic, a non-profit research tool providing expert knowledge and analytics on the management of the Covid-19 pandemic.

In this third episode, experts discuss the two big mRNA vaccine breakthroughs from Pfizer/BionTech and Moderna, which now have emergency use authorisations in a number of countries. We hear their first impressions on what the “better than expected” results tell us and how that might translate to durability, protection against severe disease and transmission. They also explore the inevitable challenges around gathering future evidence if people in the placebo group are offered the vaccines. The initial safety profile of these mRNA vaccines gets dissected including the reported allergic reactions and cases of Bell’s Palsy. Amid current limitations with these datasets, experts also discuss viewpoints on administering the vaccine to pregnant women, women who want to get pregnant and 16/17 year olds.

-- 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 Nikolai Petrovsky is a Professor of Medicine, Flinders University in Australia and vice-president and secretary general of the International Immunomics Society. He is the founder of vaccine biotech Vaccine, which has a protein based candidate in early development for Covid-19.

-- Dr Yves Van Laethem is a retired virologist from Centre Hospitalier Universitaire Saint-Pierre and is currently the spokesperson for the fight against coronavirus in Belgium.

-- Dr Scott Evans is a Professor and Founding Chair of The Department of Biostatistics and Bioinformatics at George Washington University. He is a former member of an FDA advisory committee and a member of the steering committee of the clinical trials transformation initiative.

-- Dr Michael Kurilla is the Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, US National Institute of Health. He has been a member of the advisory committee for vaccines and related biologics since 2018.

In this second episode, experts talk about what goes into designing a clinical trial, how they are set up to give answers and where they can be flawed. We'll look at a few key questions about the ongoing Covid-19 vaccine trials including the vaccines being set up to show protection against mild disease versus severe disease and how releasing results early may raise some concerns in how we can interpret the results. Experts also discuss the regulators that approve the vaccines and their tough position to release a new vaccine to the public on limited data and very tight review timelines amid the pressure of a pandemic.

-- 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 Michael Kurilla is the Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, US National Institute of Health. He has been a member of the advisory committee for vaccines and related biologics since 2018.

-- Dr Scott Evans is a Professor and Founding Chair of The Department of Biostatistics and Bioinformatics at George Washington University. He is a former member of an FDA advisory committee and a member of the steering committee of the clinical trials transformation initiative.

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

-- 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.

In this introductory episode, Surani speaks to Kent Collier, the independent sponsor of the podcast, about what this series hopes to achieve. This episode sets us up with some foundations on vaccine development, and where we are right now with the current vaccine approaches for Covid-19. We'll also get an understanding from experts on where Covid-19 sits in comparison to SARS in 2003 and the seasonal flu. Experts finally discuss their initial outlook for the future.

Expert Guests:

-- Dr Michael Kurilla is the Director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, US National Institute of Health. He has been a member of the advisory committee for vaccines and related biologics since 2018.

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

-- 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.