Brighton Collaboration News — June 2024

Brighton Collaboration News

Quarterly Updates From Our Vaccine Safety Community
June 2024

Letter from our Science Board Chair

Greetings to our colleagues around the world. It has been an impactful several years for vaccine safety and the work that we all do has never been more important! My hope is that we continue to build on this momentum, leveraging the community that Brighton represents.

Earlier this year we asked members to share their perspectives in our Member Input Survey, and we received many thoughtful responses. Thank you to everyone who shared ideas to shape our community’s communications. We learned of much fascinating and impactful work that is taking place within the Brighton Collaboration community, and we look forward to sharing highlights from our members in this issue and future issues of Brighton Collaboration News.

Inside this issue, you’ll find a story about one of our members, Alejandro Cravioto, and his work with the Pan-American Advisory Group on Vaccine Safety. We also share recaps of recent vaccine safety-focused events, including the Sixth International Neonatal and Maternal Immunization Symposium (INMIS), the World Vaccine Congress, and the European Society for Pediatric Infectious Diseases (ESPID).

In our Community Updates, you’ll find an invitation to join our members-only LinkedIn Group, where we encourage members to ask questions, problem-solve together, and connect with our global community. You’ll also find information about our membership drive, and we invite you to share this issue and our sign-up form with your colleagues so that they, too, can join Brighton Collaboration. Thank you for being a part of our community.

Denny Kim, Science Board Chair, Brighton Collaboration

Community Updates

Join Our Members-Only LinkedIn Group

Thank you to all our members who completed the Members Input Survey earlier this year. We received overwhelming interest in a members-only LinkedIn Group, where our community can network, share updates from the vaccine safety field, ask questions, and problem-solve together. Request to join the group, Brighton Collaboration Members >

Membership Drive: The Brighton Collaboration Community is growing!

We are a global network of experts dedicated to promoting and improving vaccine safety to increase public confidence in vaccines, and we’re grateful to have you as a member. Over the next several months, we aim to grow our community, which currently includes 1,300 members from 110 countries. We encourage you to invite your colleagues to join Brighton. Membership is free and open to everyone working to promote and improve vaccine safety. Members receive access to a members-only LinkedIn group for networking and problem-solving, periodic updates from the vaccine safety field, and opportunities to review and inform new Brighton products, including AESI case definitions. Share the sign-up form >

New Resource: Case Definition Companion Guide for TTS-VITT

The companion guide to the Brighton Case Definition for Thrombosis with Thrombocytopenia Syndrome (TTS) and Vaccine-induced Immune Thrombocytopenia and Thrombosis (VITT) is now available. The companion guide includes ICD-9/10-CM, MedDRA & SNOMED CT codes, background rates, risk factors, and guidance for real-time investigation, data collection, analysis, and presentation. It also includes tools such as a data abstraction and interpretation form, a tabular summary of key case definition criteria, and algorithms for level of certainty determination for TTS and VITT. This guide is already being used to assess the occurrence of TTS or VITT in several settings including as an adverse event following immunization.

Ensuring the Safety of Dengue Vaccines: Alejandro Cravioto Brings International Expertise to the Pan-American Advisory Committee on Vaccine Safety

Brighton Collaboration Science Board member, Dr. Alejandro Cravioto, is a part of the Pan-American Advisory Group on Vaccine Safety. The Advisory Group helps national advisory groups make informed decisions about the safety of vaccines they are interested in incorporating into their immunization programs. Dr. Cravioto shares that the safety of the new dengue vaccines has been established. “These vaccines have the potential not just to curb outbreaks, but actually to prevent the cases of dengue from happening,” he says. Read the full story >

Brighton Collaboration Case Definition for GBS Applied to Vaccines for Prevention of RSV (CDC Morbidity and Mortality Weekly Report

In May 2023, the Food and Drug Administration (FDA) licensed Arexvy and Abrysvo vaccines for prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in adults aged ≥60 years. In prelicensure trials, Guillain-Barré syndrome (GBS) was identified as a potential safety concern. Symptoms and health impacts reported during the week after RSV vaccination were described for V-safe participants aged ≥60 years who were vaccinated during May 3, 2023–April 14, 2024, and completed one or more daily surveys. Primary VAERS adverse event reports after RSV vaccination for persons aged ≥60 years were described by serious and nonserious classification and MedDRA PTs. Reporting rates for GBS reports that met the Brighton Collaboration case definition were estimated using available doses administered as the denominator. Read more >

The Task Force for Global Health Celebrates 40 Years of Global Health Impact

Our parent organization, The Task Force for Global Health, turns 40 this year! Founded in 1984, The Task Force works across sixteen programs to eliminate diseases, ensure access to safe, effective vaccines, strengthen health systems, and advance global health security in 150 countries. Read the story and watch the video about our 40th-anniversary celebration and the unveiling of the William H. Foege Collaboration Center.

The SPEAC Project Joins the Vaccine Safety Net

The SPEAC website, speacsafety.net, is now a member of the Vaccine Safety Net (VSN). The VSN is a Pan-American Health Organization (PAHO) project that helps people find reliable vaccine safety information. Learn more about how the VSN evaluates websites against their eligibility criteria >

Vaccine Safety in the News

WHO Says It Is Trying to Expedite Mpox Vaccination in DRC – But Faces Multiple Hurdles (Health Policy Watch) — WHO officials said that they are trying to expedite delivery of mpox vaccines to outbreak-stricken DR Congo through talks with the world’s only two mpox vaccine manufacturers, as well as extending appeals for vaccine donations and negotiations with DRC Officials.

Participants in Nigeria Vaccinated in First-ever Phase 2 Lassa Fever Vaccine Clinical Trial (CEPI) — Participants in Nigeria have been vaccinated with a Lassa fever vaccine candidate in the first Phase 2 clinical trial of any Lassa vaccine. More than 600 participants in Ghana, Liberia, and Nigeria are expected to enroll in the IAVI-sponsored trial, funded by CEPI.

Thousands Believe Covid Vaccines Harmed Them. Is Anyone Listening? (New York Times) — All vaccines have at least occasional side effects. But people who say they were injured by Covid vaccines believe their cases have been ignored.

Guidance

Development of WHO Immunization Policy and Strategic Guidance (WHO) — This guidance describes the methods and processes of the Strategic Advisory Group of Experts (SAGE) on Immunization in developing evidence-based recommendations, WHO vaccine position papers, and other immunization policy guidance. Its aim is to facilitate the work of SAGE, its working groups and the WHO Secretariat, as well as to inform a wider readership, such as national immunization managers and national immunization technical advisory groups.

A Proposed Model to Build Capacity for Emergency Use Authorization for Therapeutics—Guidance for National Medicines Regulatory Authorities (USAID and USP) — This document presents practical recommendations for strengthening operational policies and procedures for therapeutics EUAs, establishing clear review timelines, allowing for rolling submissions, using standardized application forms and checklists, and investing in electronic regulatory information systems.

Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks (National Academies of Sciences, Engineering, and Medicine) — The US Congress called on the National Academies to convene a committee to examine the real and perceived risks of liability arising from research conducted with pregnant and lactating women. The resulting report explores and finds limited evidence of legal liability for the inclusion of pregnant and lactating women in clinical research, contradicting perceptions of heightened liability.

Real-World Data and Real-World Evidence in Regulatory Decision Making (CIOMS) — In recent years, many medicines regulatory agencies have expressed increased willingness to consider real-world evidence (RWE), that derives from the review and/or analysis of real-world data (RWD), to support claims of efficacy or effectiveness as well as of safety. This increased willingness is changing the regulatory environment in which RWE is generated and used. This consensus report aims to describe the potential use of RWE for decision making; RWD and data sources; key scientific considerations in the generation of RWE; and ethical and governance issues in using RWD.

Featured Research

Obstetric Complications and Birth Outcomes After Antenatal Coronavirus Disease 2019 (COVID-19) Vaccination (Obstetrics and Gynecology) — A new large study finds mRNA COVID-19 vaccination during pregnancy was not associated with an increased risk of adverse pregnancy outcomes. This information will be helpful for patients and clinicians when considering COVID-19 vaccination in pregnancy.

A Comparison of Four Self-Controlled Study Designs in an Analysis of COVID-19 Vaccines and Myocarditis Using Five European Databases (Vaccine)  — A new methodological paper assesses the possible extent of bias due to violation of a core assumption (event-dependent exposures) when using self-controlled designs to analyze the association between COVID-19 vaccines and myocarditis.

Postmarketing Vaccine Safety Assessments (JAMA Network) — How can vaccine safety be monitored to ensure that individuals are well informed about their individual risks? In an article published in JAMA, Kathryn M. Edwards and Marie R. Griffin make the case for standardized, consistent definitions of adverse events and share that Brighton Collaboration case definitions can be effectively used across different studies.

Landscape Review of Active Vaccine Safety Surveillance Activities for COVID-19 Vaccines Globally (Vaccine) — Earlier this year we spoke with Parisa Shamaeizadeh and Rebecca Chandler about the COVID-19 Vaccine Safety Studies Project, driven by the International Vaccine Access Center at Johns Hopkins BSPH and funded by CEPI. Read the editorial about the project on brightoncollaboration.org and the published paper in Vaccine.

Maternal and Perinatal Health Research During Emerging and Ongoing Epidemic Threats: a Landscape Analysis and Expert Consultation (BMJ Global Health) — This paper identifies research efforts relevant to pregnant women affected by disease outbreaks, highlights gaps and challenges, and proposes solutions to addressing them in a coordinated manner. Having explored how existing maternal and perinatal health research platforms could be leveraged to address existing gaps and how they could be used to meet the need for a comprehensive global emergency response, it was determined that structures and mechanisms would need to be established to approach dealing with new epidemics or pandemics holistically and coherently.

Defining and Reporting Adverse Events of Special Interest in Comparative Maternal Vaccine Studies: a Systematic Review (Vaccine) — The GAIA (Global Alignment on Immunisation Safety Assessment in Pregnancy) consortium was established in 2014 with the aim of creating a standardised, globally coordinated approach to monitoring the safety of vaccines administered in pregnancy. The consortium developed twenty-six standardised definitions for classifying obstetric and infant adverse events. This systematic review sought to evaluate the current state of adverse event reporting in maternal vaccine trials following the publication of the case definitions by GAIA, and the extent to which these case definitions have been adopted in maternal vaccine safety research.

Additional Recent Publications:

Recent Events

Clockwise from top left: Wan-Ting Huang, Esperança Sevene, Barbara Law, and Manu Chaudhary

International Women’s Day | We celebrated International Women’s Day throughout the month of March. We recognized the women who lead several focus areas of our Safety Platform for Emergency vACcines (SPEAC) Project in an article, “Women in vaccine safety work to accelerate progress toward vaccine acceptance.”

From left to right: Andy Stergachis, Manu Chaudhary, and Flor Munoz

INMIS | The Sixth International Neonatal and Maternal Immunization Symposium (INMIS) took place from March 12-14 in San Jose, Costa Rica. The conference welcomed 300 participants and featured presentations from 125 experts working in maternal and neonatal immunization. Former President of Costa Rica, Laura Chinchilla, gave the keynote address. Three experts from the SPEAC project joined the conference > 

From left to right: Daniel Salmon, Karina Top, Jim Buttery, Eileen Farnon, Bob Chen, and Dale Nordenberg

World Vaccine Congress | SPEAC experts joined the World Vaccine Congress in Washington, D.C. from April 1 – 4. Three SPEAC members joined more than 5,000 other participants to explore the conference theme of “R&D and Strategic Partnering for the Global Vaccine Industry.”

Steve Black presents a poster at ESPID

European Society of Paediatric Infectious Diseases (ESPID) | SPEAC Project Executive Board member, Steve Black, presented a poster on SPEAC’s work at the ESPID meeting in May in Copenhagen. The poster was titled, “Pandemic Preparedness: Standardized Brighton Collaboration Case Definitions on Adverse Events of Special Interest” and featured AESI lists, Companion Guides to Brighton Case Definitions, and digital solutions in development as part of the SPEAC Project.

Upcoming Events and Opportunities

23rd International Vaccinology Course— Vaccine to Vaccination: From Science to Society

Join the International Vaccine Institute for the 23rd International Vaccinology Course, “Vaccine to Vaccination: from Science to Society.” The course will take place in Seoul, Stockholm, and Kigali from 2-6 September 2024. Participation is open to researchers around the world working, studying, or conducting research in vaccinology. Registration is open until 31 August 2024.

Request for Proposal – Partnership for Strengthening Clinical Trial Capacity | CEPI

Partnership for strengthening clinical trial capacity for GCP-compliant late-stage vaccine trials, generation of real-world evidence and long-term research preparedness/emergency evidence generation readiness in East and Central Africa. This Request for Proposals (RfP) is open from 10 May 2024 until 21 June 2024, 23:59:59 GMT.

Request for Proposal – Innovations to Prepare for Future Epidemics & Pandemics | CEPI

  • Focus Area 1: The objective of Focus Area 1 is to advance vaccine platforms that can transform outbreak response to Disease X, addressing needs for speed, safety/efficacy, and access. Through proposals awarded under this Focus Area, CEPI aims to build significant preclinical, CMC, clinical, and regulatory expertise with vaccine platforms that could be leveraged for rapid adoption in an outbreak and made accessible to all populations that need them.  
  • Focus Area 2: The objective for Focus Area 2 is to advance new candidates for CEPI priority pathogens and viral families, aligned with CEPI’s strategic objectives to accelerate development of vaccines against known high-risk pathogens and to build a library of vaccine prototypes from high-risk viral families to give a head-start on novel threats (Disease X).

Hendra@30 Conference | 8 – 11 December 2024 | Geelong, Victoria

The Hendra@30 conference commemorates 30 years since Hendra virus, the first henipavirus, was discovered. Join the conference in Geelong, Victoria, Australia in December 2024 to hear about the progress made through research in understanding the henipaviruses. Registration is open until 1 November 2024.

More Vaccine Safety Quarterly

Brighton Collaboration News — June 2024

June 20, 2024

VSQ Q1 2024

April 1, 2024

VSQ Q4 2023

January 3, 2024

VSQ Q3 2023

September 28, 2023

VSQ – Q2 2023

July 1, 2023

VSQ – Q1 2023

May 22, 2023

More Vaccine Safety Quarterly