Brighton Collaboration News
Quarterly Updates From Our Vaccine Safety Community
May 2025
Letter from the Science Board – Dr. Robert Wise
Over the last four decades, I’ve had the privilege of working at the intersection of medical product development and public health. In my time at FDA, NIH, and in industry, I focused on bringing safe and effective vaccines and therapeutics to the public. Across this work, the Brighton Collaboration (BC) has been a critical and constant part of my journey.
I first began using BC case definitions as an FDA safety reviewer in the early 2000s, when the community was focused on creating much-needed standards for safety monitoring and post-licensure studies. Later, I had the privilege of leading the BC working group on thrombocytopenia. The global and interdisciplinary collaboration involved in that process was striking—and a great example of how BC working groups function at their best.
Before joining the BC Science Board, I was involved in the initial response to reports of intussusception following the first licensed rotavirus vaccine. At the time, our understanding of vaccine safety and risk-benefit profiles was quite different. We had very few tools to support rapid post-marketing surveillance, and the infrastructure for adverse events following immunization (AEFI) assessment was patchy at best. The definition that ultimately emerged from that investigation became one of BC’s most important early publications—and it helped lay the groundwork for how we approach risk-benefit questions today.
The Brighton Collaboration’s multidimensional value to vaccine safety science would be very difficult to overstate. I was honored to join the Science Board in 2023, and I look forward to contributing to its work in the years to come.
-Robert P. Wise, MD, MPH
Community Updates
Science Board Updates
The Brighton Collaboration Science Board met virtually in March 2025 to review strategic priorities amid shifting global and U.S. public health landscapes. Key topics included:
- Anticipated leadership transitions and onboarding of new staff
- Data backup plans and GDPR compliance
- Implications of U.S. policy shifts: reduced funding, delayed advisory meetings
- Updates on SPEAC 2.0 and the upcoming digital Brighton toolkit
- Science Board elections: Fall 2025
New Team Members
Please welcome our newest Brighton/SPEAC team members:
- Anita Renahan-White – Associate Deputy Director
- Andrea Berlin – Project Manager
- Sarah Jones – Communications Manager
- Krutika Kuppalli – Disease X Lead (SPEAC)
- Clare Cutland – DSMB Co-Lead (SPEAC)
- Shelly Karuna – Vaccine Safety Template Co-Lead (SPEAC)
News & Resources
The SPEAC team has been hard at work these last few months, releasing a number of new tools and publications.
- Updated Safety Templates: Now available for viral vector, inactivated, nucleic acid, protein-based, and live-attenuated vaccines.
🔗 Explore BRAVATO Templates
New Data and Safety Monitoring Board (DSMB) Training Cohort
Fourteen participants from the Africa CDC (ACDC), Rwanda, Mozambique, Sierra Leone, and Benin are currently participating in Data and Safety Monitoring Board training as of March 17, 2025.
These training sessions are part of SPEAC’s work to expand DSMB expertise around theworld and to connect awardees funded by the Coalition for Epidemic Preparedness andInnovation (CEPI) with trained DSMB members.
New Case Definition Services to Support Priority Pathogen Preparedness
The Brighton Collaboration is pleased to announce the launch of a new Case Definition Support Service, designed to help developers, public health professionals, and national health authorities evaluate how well their data align with established Brighton Collaboration case definitions.
As part of our ongoing commitment to improving vaccine safety and preparedness, this service is now being extended to Cepi priority pathogens. Participating organizations can submit anonymized datasets to determine whether their case data meet Brighton Collaboration definitions and what level of diagnostic certainty can be expected. This analysis supports the development of more consistent, reliable safety and effectiveness assessments during outbreaks and clinical research.
This service is particularly valuable for stakeholders involved in product development, pharmacovigilance planning, and regulatory submissions, offering early insight into case classification compatibility and potential gaps in data collection.
To learn more or inquire about a data review, click the button to email us.
Recent Studies Related to Brighton Case Definitions
A recent Canadian study assessing revaccination outcomes in individuals with suspected hypersensitivity to COVID-19 vaccines used the Brighton Collaboration Case Definition (BCCD) to classify anaphylaxis cases consistently. Among 180 participants referred for adverse events, only 8.3% met BCCD criteria for confirmed anaphylaxis, while nearly half had symptoms that did not meet the definition. The use of the BCCD provided a standardized, objective framework for diagnosis and helped guide safe revaccination practices—supporting informed vaccine safety decisions.
2. Anaphylaxis post-COVID-19 vaccinations in Singapore
A recent study from Singapore analyzed cases of anaphylaxis following COVID-19 vaccination using the Brighton Collaboration Case Definition (BCCD) to ensure consistent classification. By applying the BCCD, researchers could accurately identify true anaphylaxis cases, distinguishing them from other adverse reactions. This standardized approach facilitated a clearer understanding of vaccine safety and supported informed decisions regarding revaccination and public health strategies.
Update from the International Network of Special Immunization Services (INSIS)
Bridging Vaccine Safety Adversomics Research in Low and Middle Income Countries (LMICs)
The International Network of Special Immunization Services (INSIS) aims to advance our understanding of the biological mechanisms underpinning rare adverse events following immunization (AEFI). Vital to this work is to ensure study findings are applicable to people around the world, not just to those in high-income countries. This requires developing and implementing strategies to collect data and biosamples on people with adverse events and vaccinated healthy people in low- and middle-income countries.
To address this gap, INSIS has built strong partnerships with the Global Vaccine Data Network (GVDN), South Africa’s University of Witwatersrand through their Vaccines and Infectious Diseases Analytics Research Unit (WitsVIDA) and the African Leadership in Vaccinology Expertise (ALIVE) Network, which includes Kenya’s KEMRI-Wellcome Trust Research Programme. With funding via the Canadian Institutes of Health Research – Coalition for Epidemic Preparedness Innovations Leadership Award in Vaccine Research, INSIS Principal Investigator, Prof. Karina Top is leading a mixed methods study with these partners to understand the challenges of vaccine safety monitoring during the COVID-19 pandemic and identify opportunities for incorporating systematic data and sample collection for AEFI investigation into future vaccine campaigns.
Researchers at KEMRI-Wellcome will also be piloting sample collection for genetic studies to contribute to the GVDN Genomics study and assessing feasibility of implementing this approach. This research aims to inform protocols for “AEFI X” investigation that support inclusion of participants in LMICs in vaccine adversomics studies. The progress to date and initial results were shared by Dr. Top at the Canadian Immunization Conference in November 2024.
To learn more information about INSIS please visit their website or LinkedIn page.
Industry News and updates
Vaccine Safety in the News
- WHO Advances Global Vaccine Safety Blueprint 2.0
The World Health Organization (WHO) continues to implement its Global Vaccine Safety Blueprint 2.0, providing strategic guidance tailored to countries’ pharmacovigilance maturity levels. The blueprint emphasizes a people-focused, country-owned, partnership-based, and data-driven approach, aligning with the Immunization Agenda 2030. World Health Organization (WHO)
- EMA Continues Monitoring COVID-19 Vaccine Safety
The European Medicines Agency (EMA) maintains ongoing surveillance of COVID-19 vaccines’ safety profiles. Current data indicate that the vast majority of known side effects are mild and short-lived, with no evidence suggesting long-term adverse effects such as cancer. European Medicines Agency (EMA)+1European Medicines Agency (EMA)+1
- Renewed Focus on Mpox Vaccine Safety Monitoring
In response to recent mpox outbreaks, the WHO’s Global Advisory Committee on Vaccine Safety emphasizes the importance of monitoring the safety of mpox vaccines, particularly MVA-BN and LC16m8, across all target populations. Special attention is advised for immunocompromised individuals, pregnant women, infants, children, and lactating women. World Health Organization (WHO)
- AI’s Emerging Role in Pharmacovigilance
Recent analyses highlight the growing application of Artificial Intelligence (AI) in pharmacovigilance, particularly in processing structured real-world data to identify safety signals. While AI offers promising advancements in vaccine safety monitoring, experts call for careful consideration of its implementation to ensure accuracy and reliability. PMC
Global Health Updates: Mpox and Emerging Outbreaks
🦠 Mpox
As of early 2025, the World Health Organization (WHO) and the Africa Centres for Disease Control and Prevention (Africa CDC) have reported that 60 countries have documented mpox cases, with the majority of infections and fatalities occurring in African nations. World Health Organization (WHO)
In response, WHO has updated its global strategic preparedness and response plan, focusing on strengthening surveillance, laboratory capacity, community protection, safe clinical care, and vaccination efforts. World Health Organization (WHO)
In the United States, there have been isolated cases of clade I mpox in individuals who recently traveled to affected regions in Central and Eastern Africa. CDC+1hpsc.ie+1
🧪 Avian Influenza A(H5N1) – Mexico
On April 2, 2025, Mexico reported its first laboratory-confirmed human infection with avian influenza A(H5N1) in the state of Durango. This case marks the second reported human infection with avian influenza A(H5) in Mexico. Local and national health authorities have implemented measures to monitor, prevent, and control the situation. World Health Organization (WHO)
💧 Cholera Outbreaks in Africa
The World Health Organization has reported a multi-country cholera outbreak in Africa, with several member states experiencing increased cases. Factors contributing to the outbreak include changing weather conditions and ongoing health emergencies. Efforts are underway to address the situation and provide support to affected regions.
🦟 Chikungunya Outbreaks
As of March 2025, approximately 80,000 cases of Chikungunya virus disease (CHIKVD) have been reported across 14 countries and territories, including regions in the Americas, Africa, and Asia. The majority of cases have been reported in Réunion Island, a French overseas department in the Indian Ocean, where over 27,000 confirmed cases have been documented since the beginning of the year. The outbreak in Réunion began in August 2024 and has escalated sharply in recent weeks, with regional health authorities estimating that up to 100,000 individuals could be infected. Seven deaths have been reported, including an infant under one month old. ECDC+1World Health Organization (WHO)+1Vax-Before-TravelCIDRAP
In response to the ongoing outbreaks, the World Health Organization (WHO) held a virtual meeting on April 8, 2025, to discuss generating high-quality evidence on existing vaccines for Chikungunya in response to outbreaks. World Health Organization (WHO)
🧬 Marburg Virus Outbreaks
In early 2025, a Marburg virus disease (MVD) outbreak was reported in the Kagera region of northwestern Tanzania. As of January 11, 2025, nine suspected cases, including eight deaths, were reported across two districts—Biharamulo and Muleba. Samples from two patients were collected and tested by the National Public Health Laboratory, with results pending official confirmation. Doctors Without Borders+9County of San Diego+9CDC+9ReliefWeb+2World Health Organization (WHO)+2GOV.UK+2
However, on March 13, 2025, the Tanzanian government declared the end of the Marburg virus outbreak after passing 42 days—two incubation periods—with no new cases following the death of the last patient. In total, there were eight probable and two confirmed cases, all of whom died. CIDRAP+1Fit for Travel+1County of San Diego+3Fit for Travel+3ReliefWeb+3
The World Health Organization (WHO) welcomed the end of the outbreak, emphasizing the importance of close collaboration and support between national authorities, WHO, and partners in successfully controlling and halting the spread of the virus. Reuters
Global Vaccine Approvals & Pipeline Highlights
🦟 Chikungunya Vaccines: Dual EU Approvals
- Vimkunya (Bavarian Nordic) received EU approval in February 2025. This recombinant, adjuvanted vaccine targets individuals aged 12 and older, marking a significant advancement in combating chikungunya in endemic regions.
- Ixchiq (Valneva) was approved in June 2024. It utilizes a live-attenuated CHIKV Δ5nsP3 strain and was fast-tracked under the EMA’s accelerated assessment program. (February 2025: Breakthrough Approvals in Global Pharmaceuticals, Chikungunya vaccine)
🧬 Self-Amplifying mRNA COVID-19 Vaccine: Zapomeran (Kostaive)
- Zapomeran (Arcturus Therapeutics) became the first self-amplifying mRNA COVID-19 vaccine approved in Japan (November 2023) and the EU (February 2025). Its self-replicating RNA technology offers potential for lower dosing and scalable production. (Zapomeran)
🧫 Updated COVID-19 Vaccines Targeting JN.1 Lineage
- Novavax’s Nuvaxovid 2024–2025 formulation received EU authorization in October 2024. This protein-based vaccine demonstrates cross-reactivity against JN.1 and related variants, providing an alternative to mRNA platforms. (Novavax’s Updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine Receives Authorization in the EU – Oct 9, 2024)
🧪 Meningococcal Combination Vaccine: Penmenvy
- Penmenvy (GSK) was approved by the FDA in February 2025. This pentavalent vaccine covers serogroups A, B, C, W, and Y, simplifying immunization schedules and enhancing protection against meningococcal disease in adolescents and young adults. (Meningococcal vaccine)
Strategic R&D and Future Outlook
Strategic R&D and Future Outlook
🧬 Cancer Vaccine Collaborations
- GSK and Oxford University have initiated a £50 million partnership focusing on cancer immunoprevention. The collaboration aims to develop mRNA-based vaccines targeting pre-cancerous cells by identifying tumor-specific neoantigens. (GSK signs £50m deal with Oxford University on cancer vaccines)
- Moderna is advancing its personalized mRNA melanoma vaccine, with potential availability by 2025. The vaccine is designed to stimulate the immune system to recognize and attack melanoma cells. (Moderna CEO Says Melanoma Vaccine Could Be Available By 2025 | Barron’s)
🦠 Norovirus Vaccine Development
- Moderna is in late-stage trials for an mRNA-based norovirus vaccine. The candidate targets multiple norovirus strains and aims to reduce severe gastroenteritis cases, particularly in vulnerable populations. (A Norovirus Vaccine May Be Coming)
🧪 Plague Vaccine Research
- Researchers from the Oxford-AstraZeneca COVID-19 vaccine team are developing a vaccine against the bubonic plague. Early trials have shown safety and immune response, addressing concerns about potential re-emergence and antibiotic resistance. (Black Death vaccine being developed amid fears the disease could return and kill millions)
Global Health Policy and Preparedness
🌎WHO Restructures
- The World Health Organization (WHO) is restructuring its Geneva headquarters, reducing ten divisions to four, with Health Systems elevated as a central pillar—an important shift for those working in vaccine safety and pharmacovigilance. The overhaul comes amid major financial strain, including a projected $600 million budget shortfall in 2025, and will consolidate many programs, including antimicrobial resistance (AMR), HIV, TB, and environmental health. AMR’s move under Health Systems, away from the One Health framework, has raised concerns about reduced visibility for integrated approaches. While the impact on immunization and safety programs is still unclear, changes to leadership and staffing—starting in June—could affect coordination, technical leadership, and resource flows across surveillance and safety-related work. WHO leadership frames the change as a strategic reset, but stakeholders are watching closely to understand the implications for core public health functions. (WHO To Shrink its Geneva Headquarters Down to Just Four Programme Divisions)
🌐 Gavi’s Funding Appeal
- Gavi, the Vaccine Alliance, is seeking to raise $9 billion by June 2025. The organization emphasizes the commercial benefits for donor countries, including support for domestic vaccine manufacturers. Reduced funding could jeopardize vaccination efforts for 75 million children worldwide. (Vaccine alliance stresses commercial benefits for US in plea for funds)
🧬 Pandemic Preparedness Initiatives
- Experts, including Prof. Emma Thomson of the University of Glasgow, stress the importance of sustained global efforts in pandemic preparedness. Advances in genetic sequencing, mRNA technology, and AI have improved threat detection, but equitable access and infrastructure remain critical challenges. (Pandemics, pathogens and being prepared: why the work to identify emerging threats never stops)
Upcoming Events and Opportunities
📅 Upcoming Conferences & Meetings in Vaccine Safety and Global Health
🧪 Vaccine Safety Summit 2025
Date: May 14–16, 2025
Location: Vienna, Austria
This annual summit brings together global leaders in vaccine safety—regulators, healthcare professionals, and researchers—to explore recent safety trends, emerging technologies, and best practices in pharmacovigilance.
🔗 More information
🌍 Global Vaccine Safety Conference
Date: July 21–23, 2025
Location: Washington, D.C., USA
Focused on vaccine safety surveillance, risk assessment, and regulatory frameworks, this conference includes hands-on workshops in advanced signal detection and forums to discuss global challenges in vaccine rollout.
🔗 More information
🧬 6th ESCMID Conference on Vaccines
Date: September 10–13, 2025
Location: TBA
From development to real-world application, this conference covers all stages of vaccine research and policy. Features include scientific sessions, expert panels, and networking opportunities.
Abstract submissions: Open until June 1, 2025
Late-breaking abstracts: Accepted August 11–29, 2025
🔗 More information
💊 ISoP 2025 – 24th Annual Meeting of the International Society of Pharmacovigilance
Date: October 24–27, 2025
Location: Cairo, Egypt
Theme: “Pharmacovigilance: Back to the Future”
This year’s ISoP meeting will focus on the evolving landscape of drug safety and the integration of emerging technologies into pharmacovigilance.
🔗 More information
🌴 ASTMH Annual Meeting 2025
Date: November 9–13, 2025
Location: Metro Toronto Convention Centre, Toronto, Canada
A premier global forum in tropical medicine and hygiene, featuring plenaries, symposia, oral/poster sessions, and unparalleled networking across global health sectors.
🔗 More information
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