Dr. Kimberley Gutu speaking at the ISoP Africa Chapter Meeting, 22–24 July 2024

Envisioning database networks for safety surveillance in Africa – opportunities and challenges

Dr. Kimberley Gutu, Project Manager at the Wits Vaccines and Infectious Diseases Analytics (VIDA) Research Unit was invited to speak at the recent ISoP Africa Chapter Meeting held in Kampala, Uganda. 

Gutu spoke on the status quo of vaccination in Africa, the role of vaccine safety surveillance and infrastructure in Africa, existing vaccine safety data networks, and implementation of the GVDN "LMIC model" using real-time hospital data and screening for possible adverse events of special interest following COVID-19 vaccination, and learnings for future surveillance across Africa. Click here to view her presentation.

Gutu said, "It was a great pleasure to present at the recent ISoP Africa Chapter Meeting in Kampala, Uganda. This opportunity allowed me to discuss how GVDN is supporting this work within the African continent and to share my personal experiences as a GVDN investigator.

"The meeting provided an excellent platform for networking and connecting with individuals from various streams in the pharmacovigilance space, including regulatory authorities, pharmaceutical companies, and academic and research institutions. The engagement during my talk was captivating, and I gained a deeper understanding of others' experiences doing similar work. I also had the chance to highlight opportunities to those previously unaware of GVDN's efforts.

"Overall, it was a very enriching experience. My sincerest gratitude goes to the GVDN directors for supporting my presentation and to the organisers of the meeting for their warm reception."

Gutu ended with an African proverb:

“If you want to go fast, go alone. If you want to go far, go together.” 

Expansion of post-authorisation vaccine safety science

A recently published article entitled Lessons learned from COVID-19, H1N1, and routine vaccine pharmacovigilance in the United States: A path to a more robust vaccine safety program by Drs. Daniel Salmon, Robert Chen, Steve Black, and Joshua Sharfstein, highlights the importance of post-authorisation vaccine safety studies to characterise the safety profile of new vaccines, describes past and present United States efforts in this area, and proposes the way forward.

In a Perspective piece Funding postauthorization vaccine-safety science published in The New England Journal of Medicine (not open access), Drs. Daniel Salmon, Walter Orenstein, Stanley Plotkin, and Robert Chen draw attention to limited funding for post-authorisation safety science. They advocate for amendment of a tax law to allow the surplus funds from the Vaccine Excise Tax to support the expansion of the detection, investigation, and prevention of vaccine adverse reactions after a vaccine is approved for use.

Salmon is Director of the Institute for Vaccine Safety (IVS). The IVS webpage Establishing Ongoing Funding for Post-authorization Vaccine Safety Science provides additional context for the Perspective piece with answers to 16 frequently asked questions (FAQs) that arise during discussions on this topic.

IVS is now on LinkedIn

Follow the Institute for Vaccine Safety LinkedIn page for content related to vaccine safety issues to assist decision making by policy makers, health care providers, and the public.

Meet two of our GVDN Biostatisticians at the WCE 2024

Drs. Arier Lee and Yannan JIang

Drs. Arier Lee and Yannan Jiang are attending the World Congress of Epidemiology (WCE) 2024 in Cape Town, South Africa, from 24–27 September 2024. If you are at the Congress, please introduce yourself to them.

Jiang is GVDN's Lead Biostatistician, a Senior Research Fellow of the Department of Statistics, and a Senior Biostatistician of the Statistical Consulting Centre at Waipapa Taumata Rau, University of Auckland. She is presenting the COVID-19 vaccines and adverse events of special interest: A multinational Global Vaccine Data Network (GVDN) signal-detection study. Known as the largest vaccine safety study ever conducted, over 99 million individuals from 10 sites across eight countries were included. Study data is also available on the interactive GVDN Observed vs. Expected Rates Dashboard.

Lee is a GVDN Biostatistician and a Senior Biostatistician in the Department of Epidemiology and Biostatistics in the School of Population Health at Waipapa Taumata Rau, University of Auckland. She is presenting on Pioneering a Unified Platform for Comprehensive Vaccine Safety Assessment – The Global Vaccine Data Network (GVDN) Initiative. Participation in the suite of association studies, for COVID-19 vaccines and Guillain-Barré syndrome, myocarditis and pericarditis, and vaccine-induced thrombosis and thrombocytopenia, spanned 15 countries. This large collaboration employed standardised protocols and statistical analysis plans to evaluate rare post-vaccination events that cannot adequately be addressed in single study sites with homogenous populations.

GVDN has established models for global vaccine safety monitoring and facilitating potential signal detection and evaluation and is well-placed to conduct future rapid response investigation of potential signals of concern for any vaccine.

Advancing vaccine safety research: 
International Network of Special Immunization Services (INSIS) initiative

The International Network of Special Immunization Services (INSIS) was established in 2021 to address knowledge gaps regarding mechanisms underlying rare adverse events of special interest (AESIs).
 
Led by Dr. Karina Top, University of Alberta, and Dr. Robert Chen, Brighton Collaboration, INSIS brings together leading experts in vaccine safety, public health, immunology, systems biology, pharmacogenomics, and specialist clinicians from five continents with the overarching aim to combine clinical investigation and ‘adversomics’ to undercover mechanisms and risk factors for rare AESIs.
 
With support from the Coalition of Epidemic Preparedness Innovations (CEPI) and in partnership with SPEAC and GVDN, INSIS is applying a multi-OMICs approach, measuring the inventory of molecules (DNA, RNA, proteins) in a single sample and integrating data across datasets to identify multi-OMIC signatures that distinguish AESI cases (e.g., myopericarditis, thrombosis with thrombocytopenia syndrome following COVID-19 vaccination) from healthy vaccinated controls.
 
Looking ahead, INSIS is expanding to other AESIs and preparing for the next vaccine safety concern through development of an “AESI X” protocol that can be implemented rapidly in high and lower resource settings and working with stakeholders to identify strategies for timely sample collection on AESI cases and controls.

Follow INSIS’ LinkedIn page for updates on network activities. INSIS is open to new members, if interested please contact info@insisvaccine.org.

Brighton Collaboration membership drive

Brighton Collaboration is growing! Become a member and receive a quarterly newsletter and opportunities to participate in the review of new products.

Click here to join the Brighton Collaboration.

SPEAC Executive Board, CEPI, and meta-DSMB members with Dr. Heidi Larson outside the London School of Hygiene and Tropical Medicine

SPEAC Executive Board meets with CEPI and meta-DSMB in London

The SPEAC Executive Board, meta-DSMB (Data and Safety Management Board), and Project Management Team joined CEPI’s Clinical Development Team in London in June to discuss strategy, ongoing work, and opportunities for collaboration. 
 
First, SPEAC’s meta-DSMB met to discuss their work to support CEPI awardees. The meta-DSMB consists of 17 global vaccine safety experts from 11 countries who review safety across CEPI-funded projects to identify possible safety concerns and patterns. Although the meta-DSMB has met routinely over the past five years, the meeting in London was the group’s first in-person event. 
 
The SPEAC Executive Board also met with Dr. Heidi Larson, Professor of Anthropology, Risk and Decision Science at the London School of Tropical Medicine and Hygiene (LSTMH). Larson shared lessons from a community engagement project during Ebola vaccine clinical trials in Sierra Leone and Ghana.  

In a meeting with CEPI’s Clinical Development Team, IQVIA, and other partners at The Wellcome Trust offices, SPEAC Executive Board members presented an overview of the SPEAC project’s first years. They also highlighted progress related to a process for AESI X case definition development and the digital transformation of SPEAC tools and resources. CEPI partners also presented their work in various aspects of vaccine safety. The meeting closed with a discussion about strategy and plans to align project activities to best support CEPI’s mission to deliver a vaccine against a pandemic pathogen in 100 days.

New Resource: The Companion Guide to the Brighton Collaboration Case Definition for Acute Aseptic Arthritis

The Companion Guide includes ICD9/10-CM, MedDRA, and SNOMED CT codes, background rates, risk factors, guidance, and tools including a data abstraction and interpretation form for acute aseptic arthritis.

Click here to view the Guide.

Just the Facts Newsletter

The weekly Just the Facts Newsletter corrects the most recent vaccine misinformation on social media and, for subscribers, is delivered straight to inboxes.

Produced by Voices for Vaccines, the newsletter complements other resources available through their website to assist in understanding vaccine hesitancy and learning to advocate for vaccines and address false claims on social media.

Dr. Punnee Pitisuttithum: Engaging community in active vaccine safety surveillance

A member of both Brighton Collaboration and the Safety Platform for Emergency Vaccines project’s meta-DSMB, Dr. Punnee Pitisuttithum not only has extensive experience serving on Data and Safety Monitoring Boards (DSMBs) but also as a principal investigator at vaccine clinical trial sites. Through her roles in clinical trials for HIV, dengue, and chikungunya vaccines, Pitisuttithum has contributed to the implementation of active vaccine safety surveillance activities that build relationships and trust at the community level.

Pitisuttithum was a clinical lead of Thailand’s HIV vaccine trial that ran from 2003–2006 in collaboration with the Thailand Ministry of Public Health, the U.S. Military HIV Research Program, and the U.S. National Institutes of Health. Community engagement and staff preparation activities began one year in advance of the trial. “I think one successful factor was the involvement of the community from the very beginning,” recounts Pitisuttithum.

Communication efforts took place early to clarify the purpose of the HIV vaccine trial, why it was taking place in Thailand, and why two provinces were selected as study sites. One of the key messages to communicate to the participants was that it was impossible to contract HIV from the vaccine. “That was one important message that we delivered well ahead of the trial implementation,” she says.

Read the full story here.

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