COVID19 Road to a vaccine MVEC

In the final episode of this podcast series our host, Associate Professor Nigel Crawford, speaks with Professor Walter Orenstein. Dr Orenstein is a Professor of Medicine, Epidemiology, Global Health and Paediatrics at Emory University; Associate Director of the Emory Vaccine Center and the Director of Emory Vaccine Policy and Development. An expert in vaccinology, Dr Orenstein has worked at the US Centers for Disease Control and Prevention, Director of the United States Immunisation Program and is a current member of several WHO groups. Further to this he is the co-editor of the vaccine textbook, Plotkin’s Vaccines, 7th edition. In this episode they discuss:

•Lessons that can be learnt from Plotkin’s Vaccines in the setting of the SARS-CoV-2 pandemic and development of vaccines
•Recent press releases showing promising early results from two mRNA COVID-19 vaccine candidates developed by Pfizer/BioNTech and Moderna
•The critical role of ongoing monitoring for safety and effectiveness of vaccines once they are in use
•The likely highest priority groups when vaccines do become available
•The role of children in SARS-CoV-2 transmission and whether or not they need to be vaccinated
•The importance of a correlate of protection in SARS-CoV-2 vaccines
•The need to monitor for vaccine associated enhanced disease (VAED)
•The importance of immunisation providers supporting reports of adverse events following immunisation (AEFI)
•The importance of communication in supporting vaccine acceptance and uptake
•Key next steps on the road to a COVID-19 vaccine: a better understanding of how many doses are required and when, a prioritisation process so the vaccines can be used most effectively (with a clear allocation system); and communicating to the public that social distancing and wearing a mask will be ongoing for some time as a level of normality won’t be reached immediately, even with the exciting new efficacious COVID-19 vaccines

Links:

Plotkin’s Vaccines, 7th ed
https://www.elsevier.com/books/T/A/9780323357616

Pfizer/BioNTech conclude phase 3 study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine

Moderna’s COVID-19 vaccine candidate meets its primary efficacy endpoint in the first interim analysis of the phase 3 COVE study
https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

In episode 17 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford, speaks to Dr Bonnie Henry, the provincial health officer (PHO) for the Province of BC in Canada. As the PHO Bonnie is leading the province’s response to the COVID-19 pandemic. Bonnie has been in this role since the beginning of 2018 and prior to this was the deputy PHO for three years. She specialises in public health and preventative medicine, and has a background working with the World Health Organisation and UNICEF polio eradication program in Pakistan and with the WHO during the Ebola outbreak in Uganda. She has experience leading responses to SARS, the H1N1 pandemic and the overdose emergency in BC. Bonnie is an associate professor at the University of British Columbia, Faculty of Medicine and is a member of the Canadian National Advisory Committee on Immunisation. She and Nigel discuss the following:

•Bonnie’s current role leading BC’s response to the COVID-19 pandemic
•What she learnt from the 2003 SARS outbreak and how this experience and knowledge can be applied to the current pandemic such as the importance of contact tracing, managing outbreaks and the importance of communicating with the public
•The role COVID-19 vaccines will play in Canada and challenges that will need to be faced such as logistics, ensuring adequate safety profiles, determining priority groups to be immunised first and protecting indigenous communities
•The critical importance of monitoring for adverse events following immunisation

Links:

The New York Times: The top doctor who aced the coronavirus test
https://www.nytimes.com/2020/06/05/world/canada/bonnie-henry-british-columbia-coronavirus.html

BC Centre for Disease Control: BC COVID-19 data
http://www.bccdc.ca/health-info/diseases-conditions/covid-19/data

Government of Canada: Chief Public Health Officer of Canada Statement on Preliminary Guidance from the National Advisory Committee on Immunization (NACI) on Key Populations for Early COVID-19 Vaccination
https://www.canada.ca/en/public-health/news/2020/11/cpho-statement-on-nacis-preliminary-guidance-on-key-populations-for-early-covid-19-vaccination.html

Government of Canada: Government of Canada signs new agreements to secure additional vaccine candidate and treatment for COVID-19
https://www.canada.ca/en/public-services-procurement/news/2020/09/government-of-canada-signs-new-agreements-to-secure-additional-vaccine-candidate-and-treatment-for-covid-19.html

BC Children's Hospital: Manish Sadarangani
https://www.bcchr.ca/msadarangani

Dalhousie University Department of Pediatrics: Karina Top
https://medicine.dal.ca/departments/department-sites/pediatrics/our-people/our-faculty/karina-top.html

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

Links:
Biologics Consulting
https://www.biologicsconsulting.com/

FDA: Expanded access
https://www.fda.gov/news-events/public-health-focus/expanded-access

FDA: Emergency Use Authorisation
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

FDA: Vaccines and related biological products advisory committee October 22 2020
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement#event-materials

MVEC: Covid19 Road to a vaccine episode 7: The importance of regulatory bodies in the development of vaccines with Professor Norman Baylor
https://mvec.mcri.edu.au/covid19-road-to-a-vaccine-episode-7-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
https://theconversation.com/halting-the-oxford-vaccine-trial-doesnt-mean-its-not-safe-it-shows-theyre-following-the-right-process-145837

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
•Mandatory vaccination
•The use of foetal embryonic cell lines in vaccine development

Links:

Australian Financial Review: Vaccine confronts humanity with next moral test
https://www.afr.com/policy/health-and-education/vaccine-confronts-humanity-with-next-moral-test-20200803-p55i66

MVEC: Foetal embryonic cells utilised in vaccine development platforms
https://mvec.mcri.edu.au/immunisation-references/foetal-embryonic-cells-utilised-in-vaccine-development-platforms/

University of Melbourne: Gaining clarity on the ethical issues of a possible COVID-19 vaccine
https://pursuit.unimelb.edu.au/articles/gaining-clarity-on-the-ethical-issues-of-a-possible-covid-19-vaccine

BMC Public Health: Including the public in pandemic planning: a deliberative approach
https://link.springer.com/article/10.1186/1471-2458-10-501

Social Science and Medicine: The use of citizens’ juries in health policy decision making: a systematic review
https://www.sciencedirect.com/science/article/pii/S027795361400166X#bbib7

RCH Grand Rounds: Let no pandemic go to waste – how the COVID crisis could lead to better health care delivery
https://blogs.rch.org.au/grandrounds/2020/09/02/let-no-pandemic-go-to-waste-how-the-covid-crisis-could-lead-to-better-health-care-delivery/

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

Links:

The Sabin Vaccine Institute
https://www.sabin.org

The Conversation: Halting the Oxford vaccine trial doesn’t mean it’s not safe – it shows they’re following the right process
https://theconversation.com/halting-the-oxford-vaccine-trial-doesnt-mean-its-not-safe-it-shows-theyre-following-the-right-process-145837

The Cutter Incident by Paul Offit
https://yalebooks.yale.edu/book/9780300126051/cutter-incident

Sabin Vaccine Institute: Immunization Advocates
https://www.immunizationadvocates.org

Sabin Vaccine Institute: Boost
https://boostcommunity.org/

The Lancet: Mapping global trends in vaccine confidence and investigating barriers to vaccine uptake: a large-scale retrospective temporal modelling study
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31558-0/fulltext

The Lancet: It is time to get serious about vaccine confidence
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31603-2/fulltext

In episode 13, our host, Associate Professor Nigel Crawford, speaks to Professor Kim Mulholland. Kim is a paediatrician and Professor of Child Health from the Murdoch Children’s Research Institute, the University of Melbourne department of Paediatrics and the London School of Hygiene and Tropical Medicine. With post-graduate training in immunology, respiratory medicine and tropical medicine, his vast experience includes developing a program of research covering all aspects of childhood pneumonia which helped guide WHO policies. He has been involved in the oversight of many vaccine trials and has served on steering committees or DSMBs for a range of vaccines including pneumococcal, dengue, RSV and COVID-19. He and Nigel discuss:

•global issues brought about by the SARS-CoV-2 pandemic and some of the surprising ways the virus has spread globally
•what we can learn from seroprevalence in countries such as India
•vaccine nationalism and the push for global solidarity
•the role of Australia in the pacific region in regards to vaccine preparedness
•global, equitable access to COVID-19 vaccines

Links:

Developing a Low-Cost and Accessible COVID-19 Vaccine for Global Health
https://www.preprints.org/manuscript/202003.0464/v1

WHO Chief Urges Nations to Join in Preventing ‘Vaccine Nationalism’
https://www.npr.org/sections/coronavirus-live-updates/2020/08/18/903617560/who-chief-urges-nations-to-join-in-preventing-vaccine-nationalism

Africa declared free of wild polio
https://mvec.mcri.edu.au/africa-declared-free-of-wild-polio/

The Meningitis Vaccine Project: A groundbreaking partnership
https://www.path.org/articles/about-meningitis-vaccine-project/

GAVI vaccine alliance
https://www.gavi.org/history-gavi