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VSQ Apr 2021 V1.0 Vaccine Safety Quarterly (VSQ) | Spring 2021 Brighton Collaboration 2.0 Frederick Varricchio, PhD, MD - Editor in Chief New Brighton Collaboration Case Definitions & Guidelines for Data Collection, Analysis, and Presentation of Immunization Safety Data and Case Definition Companion Guides The SPEAC team is developing case definitions and Case definitions, companion guides and guidelines for data collection, analysis, and pharmacovigilance presentation of immunization safety data for each An urgent global need to control the SARS-CoV-2 adverse event of special interest (AESI) in the SPEAC pandemic accelerated development of vaccines to Priority List of COVID-19 Adverse Events of Special protect against COVID-19 disease. While the new Interest. New Case Definition Companion Guides are generation vaccine platforms such as viral vector and also being developed. mRNA technologies already existed with varying Case definitions degrees of clinical experience the greater challenge was to expedite the clinical and regulatory Case definitions and guidelines for data collection, assessment processes. This was achieved by analysis, and presentation of immunization safety conducting vaccine development stages concurrently data use the Brighton Collaboration format to instead of sequentially, and with thousands of people provide a consensus case definition with defined who were willing to participate in phase I, II and III levels of diagnostic certainty that can be utilized by clinical trials of the new vaccines. Several COVID-19 clinicians and scientists for the evaluation of adverse vaccines have been granted emergency-use events following immunization. authorization. The subsequent rapid mass Companion guides vaccination rollouts across ethnically and geographically diverse populations brings the Case definition companion guides collate Brighton importance of real-time safety surveillance of Collaboration resources (risk factors, background COVID-19 vaccination to identify rare adverse events rates, ICD9/10-CM and MedDRA codes), tools (data following immunization (AEFIs), and particularly abstraction and interpretation form, tabular AESIs, during the post-authorization period to the summary of key case definition criteria and algorithm fore. for level of certainty determination, pictorial level of certainty algorithm) and guidance (real time Harmonization of AEFI and AESI reporting is investigation, data collection, analysis and essential, not only at the country level but also presentation) into a single document. These can be at the global level used to guide real time and retrospective Detection of rare AEFIs and AESIs not only requires investigation of adverse events, the latter reviewing data from very large numbers of vaccine recipients and interpreting key medical record data. but also relies on data being comparable. Use of the Brighton Collaboration case definitions and guidelines can assist clinicians to conduct The Brighton Collaboration, Task Force for Global Health, 330 W. Ponce de Leon Ave., Decatur, Georgia 30030 USA standardized assessment and reporting, and Where to find case definitions and companion standardized MedDRA/ICD-9/10-CM coding. When guides potential safety signals require urgent investigation, New, pre-publication, case definitions and guidelines prior reports of similar or the same AEFI/AESI can be and the case definition companion guides are identified in and compared across multiple available on the Brighton Collaboration case databases, such as VigiBase, the Vaccine Adverse definitions webpage. Event Reporting System (VAERS), EudraVigilance and the Yellow Card scheme. Case definitions for Vaccine-Associated Enhanced Disease, Multisystem Inflammatory Syndrome in Causality assessment needs to consider event Children and Adults (MIS-C/A) and Acute Respiratory risk factors and background rates Distress Syndrome (ARDS) have been developed Harmonized AEFI/AESI reporting can assist with since October 2020. Earlier case definitions have causality assessments but cannot be used in been published in Vaccine. isolation. Knowledge of event risk factors and the Case definition companion guides for the occurrence of the event in the population without Anaphylaxis, Acute Disseminated Encephalomyelitis exposure to the vaccine (background rate) is critical. (ADEM), Acute Encephalitis, Acute Myelitis, Aseptic When assessing potential safety signals, clinicians Meningitis, Facial Nerve Palsy, Generalized and scientists need to assess whether the event Convulsion, Guillain Barre and Miller Fisher could be biologically or medically associated with the Syndromes, and Thrombocytopenia case definitions vaccination and assess how often the event is have been developed since November 2020. occurring in the vaccine exposed population compared with the background rate. Use of the tools in the case definition companion guides can inform event risk factors and methodologies that use administrative data for the identification of AEFI/AESI background rates and Karin Batty pharmacovigilance risk assessments. The Immunisation Advisory Centre Future challenges University of Auckland Identification of potential safety signals, such as the reports of atypical thromboembolic/thrombocytopenic events in Helen Petousis-Harris Europe, require a rapid and thorough response from University of Auckland the scientific community to ensure vaccine recipient safety and to maintain global confidence in Member, Brighton vaccination. They will face additional challenges Collaboration Science Board when the rare and possibly unique syndromic events require development of new diagnostic criteria and are not captured with the existing codes nor covered by the existing case definitions. The Brighton Collaboration, Task Force for Global Health, 330 W. Ponce de Leon Ave., Decatur, Georgia 30030 USA COVID-19 Swiss-Spanish group has used this information to track virus spread across Europe. Over 100,000 citations coded COVID-19 are listed in PubMed. Many appear to be from China but from Mid-December a more contagious mutant was found many other countries as well. This is a remarkable in the UK. This mutant has already been found in achievement in one year. The signs, symptoms, several other countries. Other mutants are South course, and sequelae of this disease are still evolving Africa and Brazil which also are now widespread. and probably will continue to do so for some time. Other so far more localized mutants such as This does not include any possible relevant entries in California are being followed. Initial information is the preprint servers. There are also numerous that the current vaccines will give effective webinars some sponsored by the AMA. One issue of protection against these mutants except the South the Journal of American Medical Association had 6 African. Autoantibodies have been found in some articles on COVID-19 and dermatology, cardiology, cases and it has been proposed that they could etc. For the nonspecialist, Carlos del Rio has 15 account for some long term symptoms and articles summarizing some part of the COVID-19 coagulopathy. story. Johns Hopkins University maintains a COVID-19 WHO has issued a first report of the world's overall dashboard which provides a daily global update for response to COVID-19. This report documents 30 countries. A recent paper attempts to describe failures at every turn. And the U.S. Congress shows, COVID-19 as a multisystem disease. unintentionally, masks work. In terms of pathophysiology, the virus first binds ACE The New York Times continues to publish COVID-19 ll (angiotensin converting enzyme) receptors in the case counts as well as vaccine administration efforts nasopharynx. This receptor is present in many organs in the US. There are also detailed diagrams of the including the endothelium. It can cause total COVID-19 genome and mutants Coronavirus variant destruction of the lung but actually affects multiple tracker organ systems. Longer term effects include fatigue and somnolence, which affect about ⅓ of survivors, so called long haulers. Frequent cardiac effects have been reported and coagulopathy has been reported. For the generalist, an article on pathophysiology, transmission, diagnosis and treatment was recently published. A chronology of disease has been proposed. A review of autopsy findings is also available. A “new AE” COVID-19 related inflammatory multisystem disorder has been reported and is similar to Kawasaki disease. Its status is currently being discussed. One very important issue still unanswered is how long antibodies to Covid-19 will Daily Trends in Number of COVID-19 Cases in the United States persist (Emerg Infect Dis. 2020 Nov). Some 157,000 Reported to CDC variants of COVID-19 have been characterized. A The Brighton Collaboration, Task Force for Global Health, 330 W. Ponce de Leon Ave., Decatur, Georgia 30030 USA Treatment convalescent serum in the emergency room was halted recently for lack of efficacy. Remdesivir has been approved for use in certain cases; however, its effect appears to be modest. COVID-19 vaccine Banlanivimab, a monoclonal antibody that blocks attachment of the virus to the ACE2 receptor, The first successful vaccine trials have been recently received emergency approval. It will be completed. BioNTech-Pfizer (PB for short) and available through state health departments. It is Moderna vaccines press releases claim about 95% noteworthy that Francis Collins, the NIH director, success. First reports of actual use of these vaccines convened a meeting quickly
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