COVID19 Road to a vaccine episode 16: COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor

In episode 16 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford speaks once again with Professor Norman Baylor. Professor Baylor is the former Director of the Office of Vaccines Research and Review Center at the U.S. Food and Drug Administration (FDA) and is the President and CEO of Biologics Consulting and current advisor to the WHO.

In this episode they discuss:

• The recent FDA Vaccines and related biological products advisory committee meeting which was, as is customary, open to the public
• The huge amount countries like Australia can learn from the transparency of these open forums
• What vaccine efficacy thresholds are and what they have been set at for COVID-19 vaccine candidates in the USA
• Including children and special risk groups such as pregnant women in clinical trials
• Potential for confusion when more than one COVID-19 vaccine becomes available with varying levels of efficacy
• The ongoing collection of data to monitor vaccine safety and effectiveness
• Pauses or clinical holds being a normal part of clinical trials
• The importance of communication from regulatory bodies as COVID-19 vaccines become available

लिंक:

• Biologics Consulting
• FDA: Expanded access
• FDA: Emergency Use Authorisation
• FDA: Vaccines and related biological products advisory committee October 22 2020
• MVEC: COVID19 Road to a vaccine episode 7: The importance of regulatory bodies in the development of vaccines with Professor Norman Baylor
• The Conversation: Halting the Oxford vaccine trial doesn’t mean it’s not safe, it shows they’re following the right process

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COVID19 Road to a vaccine episode 15: Professor Lynn Gillam

In episode 15, our host, Associate Professor Nigel Crawford, speaks to Professor Lynn Gillam. Lynn is a clinical ethicist who trained in philosophy and bioethics. She is a Professor in the Centre for Health Equity, in the Melbourne School of Population and Global Health at the University of Melbourne; and the Academic Director of The Children’s Bioethics Centre at the Royal Children’s Hospital in Melbourne, Australia. The Children’s Bioethics Centre provides support including ethical decision making for clinicians in relation to patient care issues. Nigel and Lynn will discuss some of the ethical issues raised in the setting of SARS-CoV-2 vaccines, utilising a framework of points raised by Dr John Lantos from the Children’s Mercy Hospital in Kansas City, USA, at the recent Bioethics E-Conference hosted by The Children’s Bioethics Centre:

• The importance of realising that not doing something or not conducting research is a decision in itself
• The notion of “too fast can’t be safe” – some steps need to take the time they have always taken, some things can be done more quickly, recognising that if you do nothing, you are allowing harm to happen
• The role of ethical boards and the way vaccines are developed, i.e. the use of younger, healthier participants in research, not the individuals who are getting the worst disease
• The involvement of children and elderly people in clinical trials and the key differences in the ethical considerations of this
• Global equity of access to SARS-CoV-2 vaccines when they become available, who gets them first and how should these decisions be made?
• The role of Citizens’ Juries in deciding who has priority of access to vaccines in a pandemic situation
• अनिवार्य टीकाकरण
• The use of foetal embryonic cell lines in vaccine development

Links

• Australian Financial Review: Vaccine confronts humanity with next moral test
• MVEC: Foetal embryonic cells utilised in vaccine development platforms
• University of Melbourne: Gaining clarity on the ethical issues of a possible COVID-19 vaccine
• BMC Public Health: Including the public in pandemic planning: a deliberative approach
• Social Science and Medicine: The use of citizens’ juries in health policy decision making: a systematic review
• RCH Grand Rounds: Let no pandemic go to waste – how the COVID crisis could lead to better health care delivery

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COVID19 Road to a vaccine episode 14: Dr Bruce Gellin

In episode 14, our host, Associate Professor Nigel Crawford, speaks to Dr Bruce Gellin. Bruce is the President of Global Immunization at the Sabin Vaccine Institute in Washington. The Sabin Vaccine Institute’s mission is to make vaccines more accessible, enable innovation and expand immunisation across the globe. Bruce took up this role in 2017, prior to this serving as the Deputy Assistant Secretary of the National Vaccine Program Office at the US Department of Health and Human Services where he served as technical and policy advisor to the WHO, focusing on influenza vaccines and global issues of vaccine hesitancy. Bruce has also worked at the Centers for Disease Control and Prevention (CDC), consulted for GAVI and is one of America’s principle spokespeople on vaccines and immunisations. He and Nigel discuss the following in the context of vaccine confidence:

• The recent halting of the Oxford Astrazeneca trial and how the system that is in place did exactly what is supposed to
• “The Cutter Incident” and the ongoing impact this has had on vaccine safety, particularly from the manufacturing perspective
• The vast importance of ensuring immunisation providers understand the vaccine development process as if they don’t understand it and are sceptical this can have a huge impact on vaccine uptake 
• The importance of open disclosure in the vaccine development pathway
• How the Sabin Vaccine Institute is meeting the challenge of vaccine hesitancy
• Sabin’s‘Boost’ program for healthcare workers 
• How vaccines are monitored once they are in use, also called phase IV surveillance

 लिंक:

• The Sabin Vaccine Institute
• The Conversation: Halting the Oxford vaccine trial doesn’t mean it’s not safe – it shows they’re following the right process
• The Cutter Incident by Paul Offit
• Sabin Vaccine Institute: Immunization Advocates
• Sabin Vaccine Institute: Boost
• The Lancet: Mapping global trends in vaccine confidence and investigating barriers to vaccine uptake: a large-scale retrospective temporal modelling study
• The Lancet: It is time to get serious about vaccine confidence

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COVID19 Road to a vaccine episode 12: Professor Heidi Larson

In this episode of COVID19 Road to a vaccine, our host, Associate Professor Nigel Crawford speaks to Professor Heidi Larson. Heidi is an anthropologist and Director of the Vaccine Confidence Project and Professor of Anthropology at the London School of Hygiene and Tropical Medicine. The Vaccine Confidence Project is a WHO centre of excellence on addressing vaccine hesitancy. Heidi is the previous head of Global Immunisation Communication at UNICEF, chaired GAVI’s advocacy taskforce and served on the WHO SAGE working group on vaccine hesitancy. In this episode they discuss:

• How and why Heidi founded The Vaccine Confidence Project
• Why vaccine confidence is already proving to be so important in relation to a SARS-CoV-2 vaccine when there is not yet a vaccine that has gone through all the phases of a clinical trial
• Whether or not vaccine confidence is impacted by the way in which different countries are handling the SARS-CoV-2 pandemic
• The importance of health care workers modelling vaccine uptake to promote vaccine confidence
• Positive ways we can use social media to promote vaccine preparedness
• Resistance to mandatory vaccination and the importance of community vs herd immunity

लिंक:

• The Vaccine Confidence Project
• WHO: Denmark campaign rebuilds confidence in HPV vaccination
• Japan’s HPV crisis: act now to avert cervical cancer cases and deaths

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COVID19 Road to a vaccine episode 11: Associate Professor Margie Danchin and Professor Julie Leask

In episode 11 of our COVID19 Road to a vaccine series, our host, Nigel Crawford, speaks to experts in vaccine confidence, Associate Professor Margie Danchin and Professor Julie Leask. Margie is a consultant paediatrician at the Royal Children’s Hospital, an Associate Professor within the University of Melbourne Department of Paediatrics and the Murdoch Children’s Research Institute, where she is the leader of the Vaccine Uptake Group. Julie is a social scientist and professor in the Susan Wakil School of Nursing and Midwifery, Faculty of Medicine and Health, University of Sydney and a visiting Professorial Fellow at NCIRS (the National Centre for Immunisation Research and Surveillance). In this episode they discuss:

• Responses to vaccine hesitancy and promoting vaccine confidence from an Australian perspective 
• The importance of language and definitions when it comes to vaccine confidence, hesitancy and uptake 
• (5) important ways to prepare the public for a SARS-CoV-2 vaccine
• The role of social media platforms in communicating this information
• The importance of measuring vaccine confidence in the community
• Ways of communicating well around adverse events in gaining community trust and maintaining vaccine programs, including utilising expertise from specialist immunisation clinics (SICs)

लिंक:

• Vaccine: Words matter: Vaccine hesitancy, vaccine demand, vaccine confidence, herd immunity and mandatory vaccination
• COSSI Network
• Sharing Knowledge About Immunisation

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COVID19 Road to a vaccine episode 10: Professor Paul Young and Professor Trent Munro

In episode 10 of our COVID19 Road to a vaccine series, our host, Nigel Crawford, speaks with Professors Paul Young and Trent Munro to discuss the University of Queensland (UQ) COVID-19 vaccine candidate. UQ and CEPI (the Coalition for Epidemic Preparedness and Innovation) have partnered with CSL (Seqirus) to advance their novel molecular clamp technology to develop their vaccine for COVID-19. This vaccine has recently progressed to Phase 1 clinical trials. In this episode they discuss:

• The University of Queensland COVID19 vaccine development process
• The involvement of CEPI in their trial
• The use of a molecular clamp platform in the development of their protein SARS-CoV-2 vaccine
• Results of their preclinical trials
• Their partnership with CSL/Seqirus and the use of the MF59 adjuvant
• The timeline of their clinical trials and the upcoming steps 

लिंक:

• CEPI partners with University of Queensland to create rapid response vaccines
• Dosing begins in the first human trial of UQ’s COVID-19 vaccine
• The University of Queensland, CEPI and CSL partner to advance development and manufacture of COVID-19 vaccine candidate

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COVID19 Road to a vaccine episode 9: Professor Robert Booy

In episode 9 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford, speaks with Professor Robert Booy. Robert is a Professor of Paediatrics and Child Health at the University of Sydney and is a Senior Professorial Fellow at NCIRS, the National Centre for Immunisation Research and Surveillance at Westmead Children’s Hospital. He has special research interests in serious infections and their prevention, particularly in the setting of aged care facilities. In this episode they discuss:

• Special risk groups when it comes to SARS-CoV-2, in particular, those living and working in aged care facilities
• How the ageing process leads to immunosenescence and the impact of this on vaccine efficacy in the elderly population
• The use of adjuvants in vaccines for the elderly population
• How to improve public health messaging and the management of respiratory illnesses in aged care facilities
• Lessons learnt from around the world with high mortality rates in aged care residents and workers and how that can inform the response to outbreaks in aged care facilities in Australia

लिंक:

• The Conversation: Protecting our elderly: beating flu outbreaks in nursing homes 
• The Guardian: National cabinet plans rapid-response units to curb COVID-19 outbreaks in Australian aged care facilities
• PLOS One: Treating and Preventing Influenza in Aged Care Facilities: A Cluster Randomised Controlled Trial 

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COVID19 Road to a vaccine episode 8: Professor Katie Flanagan

In episode 8 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford, speaks with Professor Katie Flanagan. Katie is Head of Infectious Diseases at Launceston General Hospital and is affiliated with the University of Tasmania, Monash University and RMIT where she is involved in a broad range of research projects, with her main interests being in vaccinology and infectious diseases immunology. She has led a number of vaccine immunology trials. In this episode they discuss:

• Immunological aspects of SARS-CoV-2
• Vaccine responses in adults versus children and the difference in adult immune systems
• Vaccinology strategies being used in the development of a SARS-CoV-2 vaccine
• Antibody response variation by age
• Viral vector vaccines and how they work
• Novel vaccine approaches and the implications of these on vaccine safety including: mRNA and DNA SARS-CoV-2 vaccines 

लिंक:

• VACSIG: Vaccination Special Interest Group
• The Lancet: Immunogenicity and safety of recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults ages 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
• The Lancet: Safety and immunogenicity of the ChAdOx1 nCOV-19 vaccine against SARS-CoV-2: a preliminary report of a phase ½, single-blind, randomised controlled trial
• WHO draft landscape of COVID-19 candidate vaccines
• COVID-19 Vaccine tracker

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