Final episode of COVID19 Road to a vaccine: Professor Walter Orenstein

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

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The Conversation: Moderna’s COVID vaccine reports 95% efficacy

The American biotech company Moderna has released early data from phase III clinical trials, announcing that its COVID-19 vaccine has an efficacy level of 94.5%.

Like Pfizer's vaccine, the Moderna vaccine is also an mRNA (messenger RNA) vaccine, however will be easier to distribute as its temperature requirements are 4℃ for 30 days (rather than -70℃ as in the case of the Pfizer vaccine); and for storage requirements beyond 30 days it needs to be kept at -20℃.

The stage III trial involved 30,000 participants, out of those 95 people developed COVID-19 in the week after the final vaccination, with 90 of those being in the placebo group and only 5 in the group who received the COVID vaccine.

It is unknown how long protection from this vaccine lasts and how effective it is in the elderly, pregnant women or those with a chronic illness; however, in results Moderna published in September the vaccine produced a similar amount of antibodies in adults over 70 as adults under 70 years of age. It did however induce fewer T cells in people aged over 71, so at this stage it is not know whether this will result in lower protection or shorter lasting immunity in the elderly.

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COVID19 Road to a vaccine episode 17: How the COVID-19 pandemic is being managed in British Columbia, Canada, with Dr Bonnie Henry

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

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BBC: Covid vaccine - First 'milestone' vaccine offers 90% protection

Vaccine developers Pfizer and BioNTech have announced preliminary data shows their COVID-19 vaccine is demonstrating 90% effectiveness. The vaccine has been tested on over 43,000 people in six countries (USA, Germany, Brazil, Argentina, South Africa and Turkey). They are planning to apply for emergency approval so the vaccine can be in use by the end of November.

Requiring two doses three weeks apart, the vaccine has been developed using an mRNA platform. Scientists take part of the virus’s genetic code and coat it in a lipid so that it can enter the body’s cells resulting in the production of the coronavirus spike protein, prompting the immune system to produce antibodies and T-cells to kill the infected cells. If the person who has been immunised encounters the virus, the antibodies and T-cells are then activated to fight the virus.

It is not known how effective the vaccine will be in elderly people as yet or how long immunity will last. This vaccine is not without manufacturing and logistical challenges, as mRNA vaccines need to be stored at minus 80 degrees Celsius. To date, no major safety issues have been identified.

Read more about this via the link below:

BBC: Covid vaccine: First 'milestone' vaccine offers 90% protection 

 


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

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

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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

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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

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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)

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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 

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