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The Second SAVAC Stakeholders Meeting, 06 June 2022
Date: June 06, 2022
Type of Event: The Second Stakeholders Meeting
The second stakeholders meeting organized by the Strep A Vaccine Global Consortium (SAVAC) under the leadership of its Executive Committee, chaired by Dr. Jerome Kim, was held in Stockholm, Sweden on June 6, 2022. The meeting welcomed the participants from academia, industry, non-profit organizations, and funding agencies in-person and virtually.
SAVAC members shared each workstream’s latest progress and achievements and gaps identified. Presentations covered the Strep A burden of disease, immunity and correlates of protection, vaccine safety considerations, and the Full Value of Vaccine Assessment. The SAVAC work and comments and recommendations gathered from the participants are a catalyst for SAVAC 2.0, a logical and necessary continuation aiming at filling the gaps and translating into action the development of Strep A vaccines to ensure that safe, effective, and affordable vaccines will be available to people in need.
We are extremely grateful to the outstanding speakers and participants, and in particular to the Wellcome Trust’s generosity in funding SAVAC, who together contributed to the great success of this meeting.
The Second SAVAC Stakeholders Meeting, 06 June 2022
The First SAVAC Stakeholders Meeting, 11 March 2021
Date: March 11, 2021
Type of Event: The Stakeholders Meeting
The first SAVAC stakeholders meeting organized by the SAVAC Executive Committee (chaired by Dr. Jerome Kim, Director General of IVI, and co-chaired by Prof. Andrew Steer, Murdoch Children’s Research Institute) and the IVI Secretariat was held on March 11, 2021. The virtual meeting gathered more than a hundred participants from all over the world.
The objectives of the meeting were to review the SAVAC achievements and work in progress, discuss critical issues of Strep A vaccine development—which includes burden of disease, vaccine safety, correlates of protection, vaccine landscape, business case and investment case as components of a full value of vaccine assessment—seek advice and recommendations on next steps and increase awareness and interest of funders.
We are very grateful to the outstanding speakers and participants who contributed to the great success of the meeting, and particularly grateful to the Wellcome Trust’s generosity in funding SAVAC.
Click here to download Meeting Report.
Overview of the SAVAC Safety Working Group (SWG)
Safety is a key workstream of SAVAC. The Safety Working Group (SWG) will be critical to further defining guidance and recommendations about appropriate safety screening and monitoring during the Strep A vaccine development process.
Safety concerns relevant to all vaccines exist for Strep A vaccines including classical reactogenicity events; however, there are also particular concerns relating to the non-purulent complications of Strep A infection (acute rheumatic fever and glomerulonephritis) that are specific to Strep A vaccines. Following a clinical trial in the 1960’s of a partially purified M protein vaccine led to two of the vaccinated children developing definite rheumatic fever and one developing probable rheumatic fever. This led to an FDA prohibition of Strep A organisms and derivatives from Bacterial Vaccines and Bacterial Antigens with “No US Standard of Potency” for human use in 1979. This prohibition was lifted in 2005. Nonetheless, concerns persist regarding auto-immune disease being induced by Strep A vaccines. In the clinical trials conducted since 2005, there has been no evidence of such auto-immune disease.
As vaccines move towards trials in larger groups of adult volunteers, vaccination of the target population (children) and vaccination of high-risk groups (populations where rheumatic fever is endemic), there is a need for clear guidance about appropriate safety screening and monitoring targeting vaccine developers, clinicians, and public health stakeholders. It may hopefully benefit to regulatory agencies.
The main focus of the Safety Working Group (SWG) with relevant experts and stakeholders is to review available data and the current status and guidance for safety assessment for Strep A vaccines at the pre-clinical stage, and all phases of vaccine clinical trials, and to develop published guidance for safety assessment and monitoring for Strep A vaccines at all stages of development, and for controlled human infection studies. The core membership of the SWG was chosen to enable broad levels of expertise across the full spectrum of Strep A vaccine development including clinicians, scientists, and importantly regulators.
Prof. Edwin J. Asturias
Prof. Edwin J. Asturias Chair
University of Colorado School of
Medicine, Aurora, Colorado, USA
Edwin J. Asturias is a Professor of Pediatrics at the
University of Colorado School of Medicine and a Professor of Epidemiology at the Colorado School of Public
Health, in Aurora, Colorado, and holds the Jules Amer Chair in Community Pediatrics at Children’s Hospital
Colorado. He is member of the SAVAC Executive Committee.
Prof. Andrew Steer
Prof. Andrew Steer Co-Chair
Murdoch Children's Research Institute,
Melbourne, Australia
Andrew Steer is a leading world advocate for Group A Strep (GAS)
vaccines, leading work on the molecular epidemiology of the disease, and recently has begun to develop a
human challenge model for GAS pharyngitis. He is Co-Chair of the SAVAC Executive Committee.
Dr. Jean-Louis Excler
Dr. Jean-Louis Excler
International Vaccine Institute, Seoul, Republic of Korea
Jean-Louis Excler is pediatrician and vaccinologist with 30 years of experience in vaccine
development. He joined the International Vaccine Institute, Seoul, Republic of Korea in 2015 as Head of
Clinical Development and Regulatory and since 2018 is Program Director, New Initiatives. He is the Project
Lead of SAVAC.
Dr. Alma Fulurija
Dr. Alma Fulurija
Telethon Kids Institute, University of Western Australia, Perth
Alma Fulurija is Project Lead of Australian Strep A Vaccine Initiative (ASAVI). She is an
immunologist with expertise in immunology, vaccines and immunotherapy and has a strong interest in
understanding of host-pathogen interactions, host defence mechanisms and immunity to infectious diseases.
Dr. Beno Nyam Yakubu
Dr. Beno Nyam Yakubu
National Agency for Food and Drug Administration and Control,
Nigeria
Beno Nyam Yakubu is an experienced Regulatory Specialist with a demonstrated history
of working in the pharmaceuticals industry. Skilled in Good Laboratory Practice (GLP), Vaccines,
Biotechnology, Regulatory Requirements, and Regulatory Documentation. As Chief Regulatory Officer, he brings
the experience and perspective of the National Regulatory Authority of Nigeria.
Jim Ackland
Jim Ackland
Global BioSolutions, Melbourne, Australia
Jim Ackland
is a scientist with over 40 years of experience in the manufacture, quality control and international
registration of bio-pharmaceutical products. He is Managing Director and CEO Global BioSolutions,
Bio-Pharmaceutical Development and Regulatory Affairs Consultant.
Dr. Raj Long
Dr. Raj Long
Bill and Melinda Gates Foundation, Seattle, USA
Raj
Long is a senior executive with over 20 years of experience in drug development. Raj brings a unique
strategic expertise on regulatory affairs. She is currently a Deputy Director at the Bill & Melinda Gates
Foundation (BMGF).
Dr. Wellington Sun
Dr. Wellington Sun
Senior Consultant, Vaxcellerant, Silver Spring, Maryland, USA
Wellington Sun is infectious disease physician-scientist with diverse expertise in clinical research
and FDA regulation of infectious disease vaccines and other biotherapeutics. He was Director of the Division
of Vaccines and Related Product Applications at the FDA for 10 years and is currently a vaccine consultant
at Vaxcellerant LLC.
Dr. Marco Cavaleri
Dr. Marco Cavaleri
European Medicines Agency (EMA), Amsterdam The Netherlands
Marco Cavaleri is Head of Anti-infectives and Vaccines, EMA. He has spent several years in industry
in Research & Development for antibacterial, TB and antifungal drugs, including both non-clinical and
clinical aspects. He has been at EMA for nine years, first as scientific advisor for vaccines and
anti-infective agents, later as coordinator of regulatory activities in these areas including 2009 pandemic
influenza scientific activities.
Dr. Adwoa Bentsi-Enchill
Dr. Adwoa Bentsi-Enchill
World Health Organization, Geneva, Switzerland
Adwoa Bentsi-Enchill is an epidemiologist in the Department of Immunization, Vaccines and Biologicals of the
World Health Organization, Geneva. Adwoa has over 25 years expertise in public health with a focus on
vaccine preventable diseases. At WHO she has worked primarily on invasive salmonelloses and immunization
safety, and has had significant experience collaborating with key global stakeholders as well as providing
technical support to several countries across WHO’s six regions.
Program Management
Somyoung Cho
Somyoung Cho
International Vaccine Institute, Seoul, Republic of Korea
Somyoung Cho is Project Manager in vaccine development and delivery at IVI. She has 20 years of
professional experience with non-profit international organizations and industry in Korea and in France.
Somyoung is Project Manager of SAVAC since 2019.
Matthew Parnaby
Matthew Parnaby
Murdoch Children's Research Institute, Melbourne, Australia
Matthew Parnaby is a Public Health professional with an emphasis on healthcare for vulnerable
populations. He has 20 years of experience in Public/Primary Health Care in Emergency/Development
operations in the Middle East, Africa, Eastern Europe, Central and South East Asia and Australia. Matthew
has had an operational focus in the Tropical Diseases Group, facilitating and streamlining research
projects and programs in Australia and the Pacific Region.
Overview of the SAVAC BoDWG
Epidemiology is one of the named workstreams of SAVAC to fill the knowledge gaps in the global burden of Strep A disease in order to progress vaccine development. The main focus of the workstream is the clarification of the burden of Strep A infection and its consequences in different populations, age groups and settings. A Burden of Disease Working Group (BoDWG) was established in July 2020 to guide this work. The BoDWG will be critical to further defining the spectrum of Strep A diseases and their associated disease burden, collating data sources for interrogation, and defining critical data gaps for progressing Strep A vaccine development. The BoDWG will also identify sources of funding to address these gaps in disease epidemiology. The core membership of the BoDWG was chosen to enable broad levels of expertise across the full spectrum of Strep A infections and clinical endpoints as well as key methodological areas from bacterial disease surveillance and vaccine development and implementation in infectious diseases other than Strep A. The membership was also chosen to ensure broad representation from geographical regions, equal gender representation and allow for expansion or formation of sub-groups to allow co-opting of additional expertise as needed.
Prof. Jonathan Carapetis
Prof. Jonathan Carapetis Co-Chair
Telethon Kids Institute, University
of Western Australia
Prof. Jonathan Carapetis is the Director of the Telethon Kids Institute
in Perth, Western Australia, an infectious diseases consultant physician at the Perth Children’s Hospital
and a Professor at the University of Western Australia. Prof. Carapetis is a leader in the study of Group A
streptococcus epidemiology and disease burden. He has long been an advocate for the development of Strep A
vaccines.
Dr. Chris Van Beneden
Dr. Chris Van Beneden Co-Chair
Centers for Disease Control and
Prevention
Dr. Chris Van Beneden is a public health consultant. She worked as a medical
epidemiologist for the U.S. Centers for Disease Control and Prevention (CDC)’s for over 20 years. While at
CDC, Dr. Van Beneden directed the epidemiologic research, policy development and public health response
efforts pertaining to group A strep. She is an expert in surveillance for community acquired bacterial
infections, respiratory outbreak management, and the study of vaccines to prevent pneumococcal disease.
Dr. David Kaslow
Dr. David Kaslow, PATH
PATH Centre for Vaccine Innovation and Access
David C. Kaslow, MD, is vice president PATH Essential Medicines, supporting PATH’s Drug Innovation and
Access Initiative and PATH’s Center for Vaccine Innovation and Access (CVIA). As CVIA Head, David leads
PATH’s work to advance immunization equity and vaccination coverage to reduce vaccine-preventable diseases
through increasing and improving affordability, availability, acceptability, and sustainability of essential
existing and new vaccines for routine immunization and pandemic/epidemic preparedness and response,
particularly for those living in the lowest resources. His 35+ years of experience in product development
and introduction include the US government (NIH), biotech (Vical), multi-national pharma (Merck Research
Laboratories), and non-profit (PATH) sectors. David served in the US Public Health Service at NIAID, and
serves on a number of advisory committees, including WHO Product Development of Vaccines Advisory Committee
(PDVAC).
Dr. Thomas Cherian
Dr. Thomas Cherian
MM Global Health Consulting
Dr. Thomas Cherian
is a Managing Partner at MM Global Health Consulting, based in Geneva, Switzerland. He worked at WHO in
Geneva for 17 years, where he served as the Coordinator for the Expanded Programme on Immunization and
before that as Coordinator for Implementation Research. Before joining WHO, Dr. Cherian was Professor of
Paediatrics at the Christian Medical College in Vellore, India. Dr. Cherian has authored or co-authored over
150 scientific articles and book chapters. His main research interests have been related to acute
respiratory infections in children.
Dr. Theresa Lamagni
Dr. Theresa Lamagni
Public Health England
Dr. Theresa Lamagni is
the lead epidemiologist for streptococcal diseases at Public Health England, a WHO Collaborating Centre for
Reference and Research on Diphtheria and Streptococcal Infections. As a public health epidemiologist, she
leads national surveillance for Group A streptococcal disease and has a key role in development of guidance
for control and prevention of Group A streptococcal disease in community and hospital settings.
Assoc. Prof. Mark Engel
Assoc. Prof. Mark Engel
University of Cape Town
Mark Engel is an
Associate Professor within the Medicine Department at University of Cape Town (UCT). His research includes
all aspects of RHD, employing a wide range of investigative approaches, in efforts to improve the
understanding of this poverty-related heart disease. His research experience spans epidemiology and
population-based research, establishing registries and biorepositories, clinical sciences, health systems
and policy and, molecular research. He established AFROStrep, Africa's first multi-centre registry and
biorepository for GAS to document the occurrence and strain of infection, and to provide a platform for
training and research across the continent.
Dr. Jeff Cannon
Dr. Jeff Cannon
Telethon Kids Institute, University of Western Australia
Dr. Cannon is a Postdoc Researcher at the Harvard T.H. Chan School of Public Health and Health Economist at
the Telethon Kids Institute. His current research focuses on a Full Value of Vaccines Assessment for Strep A
vaccine. This includes investment cases to estimate the return on investment in R&D, manufacture, and
sale of a Strep A vaccine from a commercial perspective; the cost-effectiveness of vaccination form a health
payer perspective; and the return on investment in Strep A vaccines from a societal perspective,
encompassing the full health, economic, and social benefits of Strep A vaccines.
Dr. Hannah Moore
Dr. Hannah Moore
Telethon Kids Institute, University of Western Australia
Dr. Hannah Moore is Co-Head of the Infectious Disease Epidemiology Team at the Telethon Kids Institute in
Perth, Western Australia. Her current research focus involves using population-based administrative datasets
to investigate how to prevent and reduce serious respiratory and other infectious diseases in children. She
has developed expertise in identifying the pathogen-specific burden of paediatric infections and impact of
vaccination programs using record linkage methodologies.
Assoc. Prof. Asha Bowen
Assoc. Prof. Asha Bowen
Telethon Kids Institute, University of Western Australia
Assoc. Prof. Asha Bowen is a clinician-scientist at Perth Children’s Hospital and Telethon Kids
Institute. She leads clinical trials in remote Australia to reduce the burden of skin infections in
Aboriginal children. She has a range of expertise in Strep A infections including invasive Strep A (iGAS),
primary prevention of acute rheumatic fever and cellulitis. Asha leads a research team conducting studies
from bush to bench to bedside.
Dr. Anna Seale
Dr. Anna Seale
London School of Hygiene and Tropical Medicine
Dr.
Anna Seale trained in paediatrics, and subsequently epidemiology and public health, with a focus on
infectious diseases in maternal, child and newborn health. She is an Associate Professor at the London
School of Hygiene & Tropical Medicine, and an honorary public health consultant at Public Health
England. She leads the research programme of the UK Public Health Rapid Support Team, and holds a Wellcome
Trust Career Development Fellowship. Her work focusses on infectious diseases in East Africa, where she has
lived and worked for several years, developing research investigating the epidemiology and burden of
infectious disease around birth and early infancy, including for Group A Streptococcal disease.
Prof. Gagandeep Kang
Prof. Gagandeep Kang
Christian Medical College, Vellore
Professor
Gagandeep Kang works on the transmission, development and prevention of enteric infections and their
sequelae. She has worked on programmes of vaccine preventable diseases including rotavirus, cholera, typhoid
and dengue, for two decades, and has established a strong training program for students and young faculty in
clinical translational medicine aiming to build a cadre of researchers studying relevant problems in India.
Assoc. Prof. David Watkins
Assoc. Prof. David Watkins
Division of General Internal Medicine, University of
Washington
Dr. David Watkins is an assistant professor in the Division of General Internal
Medicine and in the Department of Global Health at the University of Washington. He studies global health
systems and policy challenges, and many of his projects use chronic, noncommunicable diseases like rheumatic
heart disease as models for assessing and strengthening health systems. He has participated in a number of
international committees, task forces, and working groups related to rheumatic heart disease.
Prof. Sam Kariuki
Prof. Sam Kariuki
Kenya Medical Research Institute
Prof. Sam
Kariuki is currently the Director, Research and Development at Kenya Medical Research Institute. He is
Fellow, African Academy of Sciences and a Wellcome Sanger Institute International Fellow. He is a visiting
Professor of Tropical Microbiology, Nuffield Department of Medicine, University of Oxford, UK and a member
of the American Society for Microbiology. His research interests are in epidemiology and genomics of enteric
bacterial pathogens and antimicrobial resistance. He serves as World Health Organization member of the
Advisory Group for Integrated Surveillance of Antimicrobial Resistance (AGISAR). He is a member of the
National Antimicrobial Stewardship Committee (NASIC) overseeing the implementaion of the AMR National Action
Plan in Kenya.
The 71st World Health Assembly Wraps Up With Adoption of Resolutions on Rheumatic Fever and Rheumatic Heart Disease
Date: 21–26 May 2018
Type of Event: Adoption of Resolutions
The 71st World Health Assembly, the decision-making body of the World Health Organization (WHO), was attended by delegations from all WHO Member States. The Assembly focused on a specific health agenda prepared by the Executive Board including Rheumatic Fever and Rheumatic Hearth Disease of which Group A Streptococcus (GAS) is the precipitating cause. The government of New Zealand led the drafting process to develop the Resolution, stated: ‘the facts and figures are clear.’ The delegation of Namibia also demonstrated that the number of people living with RHD around the world was comparable to those living with HIV. Member States of the WHO unanimously adopted a “Global Resolution on Rheumatic Fever and Rheumatic Heart Disease,” which was co-sponsored by countries from all six WHO regions.
Draft resolution proposed by Australia, Brazil, Canada, Cook Islands, Ecuador, Fiji, Japan, Namibia, New Zealand, Pakistan, Samoa, Tonga and Tuvalu, May 2017
Geneva, Switzerland, the 71st World Health Assembly, May 2018
IVI and WHO Host Global Consultation on Group A Streptococcal Vaccine Development
Date: December 12-13, 2018
Type of Event: WHO Consultation
The International Vaccine Institute (IVI) and the World Health Organization (WHO) co-hosted the Global Stakeholder Consultation on Group A Streptococcal (GAS) Vaccine Development at the Sheraton Seoul Palace Gangnam Hotel from December 12-13.
The one-and-a-half-day meeting convened international scientific experts, vaccine developers and funders to review evidence on GAS burden of disease and the need for a vaccine, and to discuss the feasibility and pathway for developing GAS vaccines. The meeting was in line with WHO’s goal to accelerate the development and licensure of high-quality, safe and effective GAS vaccines for low-and middle-income countries.
“The consultation provides an excellent opportunity to discuss, coordinate and mobilize resources and action at a global level to take concerted action against group A Streptococcus,” said Jerome Kim, IVI Director General, “The increasing body of evidence shows that the burden of GAS diseases and its linkage with poverty cannot be ignored. The global health community must work together to accelerate the development of a vaccine against this major killer.”
Seoul, Republic of Korea, International Vaccine Institute, December 12-13, 2016
The WHO Consultation on GAS Vaccine R&D
Date: March 16-17, 2018
Type of Event: WHO Consultation
In May 16-17, 2018, the WHO Consultation on GAS Vaccine R&D was held in London, UK. About 70 scientists from the whole world attended the consultation. The consultation was initiated by reviewing the present status of GAS Vaccine R&D and identifying bottlenecks. All the top brains of various Companies and Institutes that are interested in the GAS vaccine, gathered together, discussing and sharing the latest advances in the field.
The World Health Organization's Initiative for Vaccine Research (WHO IVR) aims to promote and accelerate the development of Streptococcus A vaccines, global health needs highlighted by the WHO PDVAC. Accordingly, WHO preferred product characteristics (PPC)—an early development stage precursor to class- or product-specific target product profiles— have been proposed and an R&D technology roadmap presented
The meeting took place at the Wellcome Trust Headquarters in London. The Wellcome Trust was a potential donor to accelerate Strep A vaccine development through the constitution of a consortium. IVI applied to lead this consortium and was awarded the 24-month Welcome Trust grant in 2019.
London, UK, Wellcome Trust, May 16-17, 2018
WHO-PDVAC 5th Annual Meeting
Date: June 26-27, 2018
Type of Event: WHO-PDVAC
WHO’s Product Development for Vaccines Advisory Committee (PDVAC) was convened for its 5th annual meeting. This was building on previous PDVAC meetings in 2015 and 2017 that put Strep A vaccines on their agenda. Over two days, progress was discussed in vaccine and monoclonal antibody development for the 10 previously prioritized pathogen areas including Streptococcus A vaccines. Several cross-cutting topics were considered, such as the potential role of vaccines in addressing antimicrobial resistance (AMR) and two new vaccine product development initiatives, namely Total Systems Effectiveness (TSE) and the Vaccine Innovation Prioritization Strategy (VIPS), were presented.
SAVAC Kick-off, Perth, March 7-8, 2019
Date: March 7-8, 2019
Type of Event: Kick-off meeting
Core members of the SAVAC attended the kick-off meeting to cover various issues on accelerating the development of a Group A streptococcus (GAS) Vaccine. The kick-off meeting identified the activities to be organized in each of its six pillars, which entailed Epidemiology, the burden of disease, the business case with landscape analysis in the literature review, traditional investment case, and encompassing health, social, and economic benefits. Among one its general considerations, all acknowledged that SAVAC would work together and with WHO/IVR, and strengthen the interaction between partners and stakeholders to streamline the implementation phase. The outreaching objectives were to address preliminary work plans and to justify the development of a vaccine for GAS through a comprehensive WHO PHVP of which the business case and the global health investment case.
SAVAC in Cape Town, March 13-15, 2019
Date: March 13-15, 2019
Type of Event: The Inaugural PROTEA Workshop, Partnerships For Children With Heart Disease In Africa
With the aim of fostering ground-breaking, bold, scalable research ideas for RHD for significant global impact, the meeting was held to support interdisciplinary partnerships for children with heart disease in Africa. Sponsored by the University of Manchester, the University of Cape Town, Medical Research Council (MRC), and Children’s’ Heart Disease Research Unit, the meeting highlighted four distinct themes: (1) bringing together and further train colleagues from South Africa and around the World to focus on novel research ideas to impact and change the lives of those living with RHD (2) providing feedback and further training into Echocardiography as we demonstrate how research can impact clinical practice (3) Congenital heart disease, diagnosis, follow-up care, surgery, and genetics. (4) RHD Prevention with plenary presentations and Think Thank sessions aiming at identifying various gaps in diagnosis, disease burden, care & treatment, and prevention including vaccines.
Prof. Andrew Steer, Co-Chair of SAVAC, delivers a lecture on “Development of Strep A Vaccine” at IVI
Date: September 02-06, 2019
Type of Event: IVI International Vaccinology Course
The Co-Chair of SAVAC, Andrew Steer, was invited to deliver a lecture on ‘Development of Strep A Vaccine' during IVI's 19th International Course of Vaccinology 2019. In addition to 134 trainees from 49 countries, the five-day course brought together 41 individual experts from academia, government, industry, and non-governmental organizations, thereby establishing a comprehensive overview of vaccinology with a focus on practicality.
Prof. Andrew Steer, IVI International Vaccinology Course, September 2-6, 2019.
On September 4, 2019, Prof. Andrew Steer covered a wide spectrum on Strep A vaccine development from discovery to delivery, to help increase developing nations' capacity in vaccine research and immunization.
“The Group A streptococcus (GAS), Streptococcus pyogenes, is the biggest infectious killer that no one has heard of. Infection with GAS causes 500,000 annual deaths,” he said. “The enormity of this problem stands in contrast with resources available to develop a vaccine for GAS. GAS vaccine funding as well as develop documents justifying investment in GAS vaccines at business and policy levels, will fill a critical need.”