Afleveringen

  • The final episode of COVID19 Road to a vaccine with Professor Walter Orenstein

    The final episode of COVID19 Road to a vaccine with Professor Walter Orenstein

    · COVID19 Road to a vaccine

    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

  • How the COVID-19 pandemic is being managed in British Columbia, Canada, with Dr Bonnie Henry

    How the COVID-19 pandemic is being managed in British Columbia, Canada, with Dr Bonnie Henry

    · COVID19 Road to a vaccine

    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

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  • COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor

    COVID-19 vaccine candidates regulatory process update with Professor Norman Baylor

    · COVID19 Road to a vaccine

    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

  • Ethical considerations on the road to a COVID-19 vaccine with Professor Lynn Gillam

    Ethical considerations on the road to a COVID-19 vaccine with Professor Lynn Gillam

    · COVID19 Road to a vaccine

    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/

  • Vaccine acceptance with Dr Bruce Gellin

    Vaccine acceptance with Dr Bruce Gellin

    · COVID19 Road to a vaccine

    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

  • Global issues brought about by SARS-CoV-2 with Professor Kim Mulholland

    Global issues brought about by SARS-CoV-2 with Professor Kim Mulholland

    · COVID19 Road to a vaccine

    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

  • Vaccine confidence from a global perspective with Professor Heidi Larson

    Vaccine confidence from a global perspective with Professor Heidi Larson

    · COVID19 Road to a vaccine

    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
    Links:

    The Vaccine Confidence Project:
    https://www.vaccineconfidence.org

    WHO: Denmark campaign rebuilds confidence in HPV vaccination
    https://www.euro.who.int/en/countries/denmark/news/news/2018/3/denmark-campaign-rebuilds-confidence-in-hpv-vaccination

    Japan’s HPV crisis: act now to avert cervical cancer cases and deaths
    https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(20)30047-5/fulltext

  • Vaccine confidence with Associate Professor Margie Danchin and Professor Julie Leask

    Vaccine confidence with Associate Professor Margie Danchin and Professor Julie Leask

    · COVID19 Road to a vaccine

    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 at the 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)

    Links:

    Vaccine: Words matter: Vaccine hesitancy, vaccine demand, vaccine confidence, herd immunity and mandatory vaccination
    https://www.sciencedirect.com/science/article/pii/S0264410X19315981?via%3Dihub

    COSSI Network
    http://www.ncirs.org.au/COSSI

    Sharing Knowledge About Immunisation
    http://ncirs.org.au/our-work/sharing-knowledge-about-immunisation

  • The University of Queensland COVID-19 vaccine with Professors Paul Young and Trent Munro

    The University of Queensland COVID-19 vaccine with Professors Paul Young and Trent Munro

    · COVID19 Road to a vaccine

    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

    Links:

    CEPI partners with University of Queensland to create rapid response vaccines:
    https://cepi.net/news_cepi/cepi-partners-with-university-of-queensland-to-create-rapid-response-vaccines/

    Dosing begins in the first human trial of UQ’s COVID-19 vaccine
    https://stories.uq.edu.au/news/2020/first-human-trial-of-UQs-COVID-19-vaccine/index.html

    The University of Queensland, CEPI and CSL partner to advance development and manufacture of COVID-19 vaccine candidate:
    https://www.csl.com/news/2020/20200605-uq-cepi-and-csl-partner-for-covid-19-vaccine-candidate

  • SARS-CoV-2 special risk groups: aged care residents and workers with Professor Robert Booy

    SARS-CoV-2 special risk groups: aged care residents and workers with Professor Robert Booy

    · COVID19 Road to a vaccine

    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

    Links:

    The Conversation: Protecting our elderly: beating flu outbreaks in nursing homes
    https://theconversation.com/protecting-our-elderly-beating-flu-outbreaks-in-nursing-homes-2960

    The Guardian: National cabinet plans rapid-response units to curb COVID-19 outbreaks in Australian aged care facilities
    https://www.theguardian.com/australia-news/2020/aug/07/national-cabinet-plans-rapid-response-units-to-curb-covid-19-outbreaks-in-australian-aged-care-facilities?CMP=Share_iOSApp_Other

    PLOS One: Treating and Preventing Influenza in Aged Care Facilities: A Cluster Randomised Controlled Trial
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3474842/

  • Vaccine approaches and immunological aspects of SARS-CoV-2 with Professor Katie Flanagan

    Vaccine approaches and immunological aspects of SARS-CoV-2 with Professor Katie Flanagan

    · COVID19 Road to a vaccine

    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

    Links:

    VACSIG: Vaccination Special Interest Group
    https://www.asid.net.au/groups/vacsig

    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
    https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31605-6/fulltext

    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
    https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31604-4/fulltext

    WHO draft landscape of COVID-19 candidate vaccines:
    https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

    COVID-19 Vaccine tracker
    https://www.covid-19vaccinetracker.org/

  • The importance of regulatory bodies in the development of vaccines with Professor Norman Baylor

    The importance of regulatory bodies in the development of vaccines with Professor Norman Baylor

    · COVID19 Road to a vaccine

    In episode 7 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford speaks 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 important role of regulatory authorities in the development and release of new vaccines
    •Emergency Use Authorisations (EUA) and their use
    •Compressed timelines in the development of SARS-CoV-2 vaccines
    •Requirements of regulatory bodies in the development of vaccines
    •Opportunities for collaboration/”work-sharing” between the national regulatory bodies (FDA, EMA and TGA)
    •The role of regulatory bodies in vaccine safety

    Links:

    WHO draft landscape of COVID-19 candidate vaccines
    https://www.google.com/search?client=safari&rls=en&q=WHO+draft+landscape+of+COVID-19+candidate+vaccines&ie=UTF-8&oe=UTF-8

    Biologics Consulting
    https://www.biologicsconsulting.com

    FDA cautions against use of hydroxychloroquine for COVID-19
    https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

    FDA: Vaccines
    https://www.fda.gov/vaccines-blood-biologics/vaccines

    WHO: Vaccine regulation
    https://www.who.int/immunization_standards/vaccine_regulation/en/

    TGA: Vaccines overview
    https://www.tga.gov.au/vaccines-overview

  • The impact of SARS-CoV-2 on children and health care workers with Professor Paul Offit

    The impact of SARS-CoV-2 on children and health care workers with Professor Paul Offit

    · COVID19 Road to a vaccine

    In episode 6 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford, speaks to Professor Paul Offit. Professor Offit is an infectious diseases physician and Director of the Children's Hospital of Philadelphia (CHoP) Vaccine Education Center (VEC). The VEC website inspired the creation of the Melbourne Vaccine Education Centre, the host of this podcast series.

    In this episode they discuss:

    •The impact of SARS-CoV-2 on health care workers and the importance of a vaccine
    •Preventative therapies and randomised controlled trials in a pandemic, specifically the use of hydroxychloroquine for COVID-19 and the other trials involving health care workers
    •COVID-19 in children - do they play a role in transmission? Will they be a target for vaccine studies?
    •Paediatric Inflammatory Multisystem Syndrome (PIMS) - how can we factor this emerging condition into safety planning?

    Links:
    Melbourne Vaccine Education Centre:
    https://mvec.mcri.edu.au

    New York Times: We know crowding affects the spread. It may affect the death rate.
    https://www.nytimes.com/2020/04/27/opinion/coronavirus-crowds.html

    New York Times: Re-thinking COVID-19 in children
    https://www.nytimes.com/2020/05/12/well/family/coronavirus-children-covid-19.html

    Vaccine Education Center
    https://www.chop.edu/centers-programs/vaccine-education-center

    MVEC: Clinical trial of BCG vaccine against COVID-19
    https://mvec.mcri.edu.au/clinical-trial-of-bcg-vaccine-against-covid-19-brace/

    Paul Offit: Deadly Choices
    http://paul-offit.com/booksby/deadly-choices/

    Paul Offit: The Cutter Incident
    http://paul-offit.com/booksby/the-cutter-incident/

  • An Australian perspective on COVID-19 vaccine candidates with Professor Terry Nolan

    An Australian perspective on COVID-19 vaccine candidates with Professor Terry Nolan

    · COVID19 Road to a vaccine

    In episode 5 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford speaks to Professor Terry Nolan. Professor Nolan is a Redmond Barry Distinguished Professor at the Doherty Institute for Infection and Immunity. He heads up VIRGO, the vaccine and immunisation research group, a collaboration between Murdoch Children's Research Institute and the University of Melbourne. VIRGO has the largest and longest standing child and adolescent vaccine population research and clinical trials program in Australia. He previously chaired ATAGI, the Australian Technical Advisory Group on Immunisation and was a member of SAGE, the World Health Organisation's main advisory group on vaccines and immunisation. They discuss the COVID-19 candidate vaccines from an Australian perspective and Australia's role in global clinical trials.

    Links:

    •The Lancet: A real time dashboard of clinical trials for COVID-19:
    https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30086-8/fulltext?utm_campaign=tlcoronavirus20&utm_source=twitter&utm_medium=social#relAudio

    •ClinicalTrials.Gov:
    https://clinicaltrials.gov

    •Global Coronavirus COVID-19 Clinical Trial Tracker:
    https://www.covid-trials.org/

    •WHO Draft landscape of COVID-19 vaccine candidates:
    https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines

    •Chief Scientist: The most promising vaccines for COVID-19:
    https://www.chiefscientist.gov.au/sites/default/files/2020-05/rrif-covid19-promising-vaccines.pdf

    •WHO: SAGE
    https://www.who.int/immunization/policy/sage/en/

  • The specific virus characteristics of SARS-CoV-2 with Professor Kanta Subbarao

    The specific virus characteristics of SARS-CoV-2 with Professor Kanta Subbarao

    · COVID19 Road to a vaccine

    In episode 4 of our COVID19 Road to a vaccine series, our host, Associate Professor Nigel Crawford, will be speaking to Professor Kanta Subbarao. Professor Subbarao has been the Director of the World Health Organisation Collaborating Centre for Reference and Research on Influenza since 2016, based at The Doherty Institute at the University of Melbourne, Australia. She is a virologist and physician who specialises in paediatric infectious diseases. Her research is focused on influenza, as well as newly emerging viral diseases of global importance such as SARS and MERS, which includes immune responses to infection and vaccination.

    In this episode they discuss:

    •The specific virus characteristics of SARS-CoV-2
    •How the biosafety laboratory at VIDRL (Victorian Infectious Diseases Reference Laboratory) were able to culture the SARS-CoV-2 virus and distribute their findings globally
    •The origin of coronaviruses and why this pandemic strain is different
    •The spike protein and the important role antibodies play in the development of a SARS-CoV-2 vaccine
    •Immunological principles in the development of a SARS-CoV-2 vaccine
    •How to determine an antibody is functional and protective
    •The likelihood of SARS-CoV-2 changing over time

  • The Oxford Vaccine Group's COVID-19 vaccine trial with Professor Andrew Pollard

    The Oxford Vaccine Group's COVID-19 vaccine trial with Professor Andrew Pollard

    · COVID19 Road to a vaccine

    In episode 3 of our COVID19 Road to a vaccine series our host, Associate Professor Nigel Crawford will be speaking to Professor Andrew Pollard, Professor of Paediatric Infection and Immunity at the University of Oxford. Professor Pollard is head of the Oxford Vaccine Group, who, along with the Jenner Institute, are running the Oxford COVID-19 vaccine trial.

    They will be be discussing:

    •The Oxford Vaccine Centre's COVID-19 vaccine trial being run by the Oxford Vaccine Group and The Jenner Institute which Professor Pollard is co-leading
    •How the Oxford Vaccine Group's previous work on the Middle Eastern Respiratory Syndrome (MERS) coronavirus vaccine enabled them to commence work on a SARS-2 vaccine very quickly, using the same platform
    •How the prior research into MERS and SARS vaccines gave huge insight into biology of coronaviruses and likely protective antigens
    •Vaccine safety concerns in vaccine development like antibody enhanced disease (AED) and the important role of vaccine safety in trial design and evaluation
    •An update on progress of The Oxford Vaccine Centre's current trials with the ChAdOx1 nCoV-19 vaccine
    •The use of a control arm in randomised trials and how the COVID-19 Oxford Vaccine Trial are using a meningococcal vaccine in their control arm
    •How declining disease in the community resulting in lower transmission and flattening of the curve affects both vaccine trial design and location of study sites
    •The upscaling of vaccine manufacturing required in a pandemic and how critical it is that there is global, equitable access to vaccine(s) when they are available

    Link:

    https://covid19vaccinetrial.co.uk

  • The importance of vaccine safety when developing a new vaccine with Professor Kathryn Edwards

    The importance of vaccine safety when developing a new vaccine with Professor Kathryn Edwards

    · COVID19 Road to a vaccine

    In episode 2 of our ‘COVID19 Road to a vaccine series’, Associate Professor Nigel Crawford, from the Murdoch Children’s Research Institute (MCRI), Melbourne, Australia, speaks with Professor Kathryn Edwards. Dr Edwards is a professor of paediatrics in the division of infectious diseases at Vanderbilt University School of Medicine in Nashville, Tennessee, where she is also vice-chair for clinical research. She is an internationally-recognised expert in vaccinology and, in particular, vaccine safety.

    They will be discussing the important topic of vaccine safety when developing a new vaccine, including some of the challenges faced in the COVID19 vaccine development pathway.

    In this episode they discuss:

    •Professor Edwards' perspective on vaccine safety across her roles as a clinician/scientist/researcher
    •Adverse events following immunisation and their implications when developing new vaccines
    •Vaccine safety across the different phases (I to IV) of clinical trials
    •The importance of data safety and monitoring committees in vaccine trials
    •What we can learn from the historical research into the development of SARS and MERS vaccines
    •What is ADE (antibody-dependent enhancement of virus infection) and why is it an important consideration in COVID19 vaccine development?
    •What are adjuvants and how does the use of them affect safety planning?
    •Should pregnant women and children be involved in vaccine trials and how can their participation be managed safely?
    •The importance of transparency and honest communication with the public in regards to vaccine safety

  • The global pursuit of a COVID-19 vaccine with Emeritus Professor Stanley Plotkin

    The global pursuit of a COVID-19 vaccine with Emeritus Professor Stanley Plotkin

    · COVID19 Road to a vaccine

    In Episode 1 of our new podcast series, Associate Professor Nigel Crawford, a vaccinologist and consultant paediatrician at the Murdoch Children’s Research Institute (MCRI) & Royal Children’s Hospital (RCH), Melbourne, talks with Stanley Plotkin, Emeritus Professor of Paediatrics at the University of Pennsylvania; who is well known internationally for his role in vaccine development.

    In this episode they discuss:
    •Professor Plotkin’s role in the development of the rubella vaccine, still used throughout the world today
    •His role as the Editor in Chief of the ‘Vaccines’ textbook
    •His role in the formation of the Coalition for Epidemic Preparedness and Innovation (CEPI) and CEPI’s current role in global COVID-19 vaccine development
    •What can we learn from the H1N1 pandemic in the development of a COVID-19 vaccine?
    •How developing a vaccine against coronaviruses is critical to the future of civilisation as economies are being destroyed by these viruses
    •Human challenge models and some of the ethical considerations we need to tackle if these sorts of trials are going to be undertaken to support COVID-19 vaccine development
    •Success can only be achieved through global collaboration in the pursuit of a COVID-19 vaccine
    •How the practical aspects of distributing a vaccine on this scale have never been faced before and the importance of thinking outside the box!

    Resources
    •Plotkin’s Vaccines (7th edition) - https://www.elsevier.com/books/T/A/9780323357616
    •Vaccine: Extraordinary diseases require extraordinary solutions - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167540/
    •Coalition for Epidemic Preparedness and Innovation - https://cepi.net