Jane Gidudu

Guillain-Barré syndrome and Fisher syndrome: case definitions and guidelines for collection, analysis, and presentation of immunization safety data.

ames J. Sejvara,∗, Katrin S. Kohla, Jane Gidudua, Anthony Amatob, Nandini Bakshic, Roger Baxterc, ale R. Burwend, David R. Cornblathe, Jan Cleerbout f, Kathryn M. Edwardsg, Ulrich Heiningerh, ichard Hughes i, Najwa Khuri-Bulos j, Rudolf Korinthenbergk, Barbara J. Lawl, Ursula Munrom, elena C. Maltezoun, Patricia Nello,1, James Oleskep, Robert Sparksq, Priscilla Velentgasr, atricia Vermeers, Max Wiznitzer t, The Brighton Collaboration GBS Working Group2

A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case definition and guidelines as an adverse event following immunization as well as the rationale for selected decisions about the case definition for a local reaction at or near the injection site are explained in the Preamble section. The case definition is structured in 2 levels of diagnostic certainty: level 1 includes any description of morphological or physiological change at or near the injection site that is described or identified by a healthcare provider. Level 2 is any description of morphological or physiological change at or near injection site that is described by any other person. In Guidelines section, the working group recommends to enable meaningful and standardized data collection, analysis, and presentation of information about a local reaction at or near the injection site. However, implementation of all guidelines might not be possible in all settings. The availability of information may vary depending upon resources, geographic region, and whether the source of information is a prospectively designed clinical trial, a post-marketing surveillance or epidemiologic study, or an individual report of a local reaction at injection site.

The concept of vaccination failure

Despite remarkable success of immunization programmes on a global perspective, vaccines are neither 100% efficacious nor 100% effective. Therefore, vaccination failure, i.e. occurrence of a specific disease in an individual despite previous vaccination, may occur. Vaccination failure may be due to actual vaccine failure or failure to vaccinate appropriately. Universally accepted concepts and definitions of vaccination failure are required to assess and compare the benefit of vaccines used in populations. Here we propose general definitions for types of vaccination failure. In the future, these should be complemented by specific definitions for specific vaccines as needed depending on public health considerations.

Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries.

Can the Brighton Collaboration case definitions be used to improve the quality of Adverse Event Following Immunization (AEFI) reporting?: Anaphylaxis as a case study.

The Brighton Collaboration (BC) was established in 2000 with the aim of developing globally accepted standardized case definitions for adverse events following immunizations (AEFI) as well as guidelines for the collection, analysis and presentation of surveillance data. Some of the BC case definitions are complex and this may limit their application for use in post-marketing vaccine surveillance. Barriers to the application of the BC case definitions include an incomplete description of an adverse event and inconsistencies in reporter use of adverse event terms. We have taken the BC case definition for anaphylaxis and developed a clinical checklist and glossary of terms used in the case definition. It is anticipated that these resources can be used at a community level by AEFI reporters. If used, these resources could improve the quality of adverse event reports which would facilitate the application of the BC case definition at a regional and/or national level.

Immediate hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines: reports to VAERS.

BACKGROUND Hypersensitivity disorders following vaccinations are a cause for concern. OBJECTIVE To determine the type and rate by age, gender, and vaccine received for reported hypersensitivity reactions following monovalent 2009 pandemic influenza A (H1N1) vaccines. DESIGN A systematic review of reports to the Vaccine Adverse Event Reporting System (VAERS) following monovalent 2009 pandemic influenza A (H1N1) vaccines. SETTING/PATIENTS US Civilian reports following vaccine received from October 1, 2009 through May 31, 2010. MEASUREMENTS Age, gender, vaccines received, diagnoses, clinical signs, and treatment were reviewed by nurses and physicians with expertise in vaccine adverse events. A panel of experts, including seven allergists reviewed complex illnesses and those with conflicting evidence for classification of the event. RESULTS Of 1984 reports, 1286 were consistent with immediate hypersensitivity disorders and 698 were attributed to anxiety reactions, syncope, or other illnesses. The female-to-male ratio was ≥4:1 for persons 20-to-59 years of age, but approximately equal for children under 10. One hundred eleven reports met Brighton Collaboration criteria for anaphylaxis; only one-half received epinephrine for initial therapy. The overall rate of reported hypersensitivity reactions was 10.7 per million vaccine doses distributed, with a 2-fold higher rate for live vaccine. LIMITATIONS Underreporting, especially of mild events, would result in an underestimate of the true rate of immediate hypersensitivity reactions. Selective reporting of events in adult females could have resulted in higher rates than reported for males. CONCLUSIONS Adult females may be at higher risk of hypersensitivity reactions after influenza vaccination than men. Although the risk of hypersensitivity reactions following 2009 pandemic influenza A (H1N1) vaccines was low, all clinics administering vaccines should be familiar with treatment guidelines for these adverse events, including the use of intramuscular epinephrine early in the course of serious hypersensitivity reactions.

Diarrhea: Case definition and guidelines for collection, analysis, and presentation of immunization safety data ,

. Gidudua,∗, D.A. Sackb, M. Pinac, M.J. Hudsond, K.S. Kohla, P. Bishope, A. Chatterjee f, E. Chiappinig, . Compingbutraa, C. da Costah, R. Fernandopulle i, T.K. Fischer j, P. Habera, W. Masanak, artins R. de Menezes l, G. Kangm, N. Khuri-Bulosn, L.A. Killiono, C. Nairp, G. Poerschkeq, B. Rathr, . Salazar-Lindos, R. Setseb, P. Wenger t, V.C.N. Wongu, K. Zamanv, he Brighton Collaboration Diarrhea Working Group

Immunization site pain: Case definition and guidelines for collection, analysis, and presentation of immunization safety data

mmunization site pain: Case definition and guidelines for collection, analysis, nd presentation of immunization safety data ane F. Gidudua,∗, Gary A. Walcob, Anna Taddioc, William T. Zempskyd, Scott A. Halperine, ngela Calugara, Neville A. Gibbs f, Renald Hennigg, Milivoj Jovancevich, Eva Netterlid i, erri O’Connor j, James M. Oleskek, Frederick Varricchio l,1, Theodore F. Tsaim, Harry Seifertn, nne E. Schuindn, The Brighton Immunization Site Pain Working Group2

Clinical assessment of serious adverse events in children receiving 2009 H1N1 vaccination.

Background: Monovalent 2009 H1N1 influenza vaccines were licensed and administered in the United States during the H1N1 influenza pandemic between 2009 and 2013. Methods: Vaccine Adverse Event Reporting System received reports of adverse events following immunization (AEFI) after H1N1 vaccination. Selected reports were referred to the Centers for Disease Control and Prevention’s Clinical Immunization Safety Assessment network for additional review. We assessed causality using modified World Health Organization criteria. Results: There were 3,928 reports of AEFI in children younger than age 18 years after 2009 H1N1 vaccination received by January 31, 2010. Of these, 214 (5.4%) were classified as serious nonfatal and 109 were referred to Clinical Immunization Safety Assessment for further evaluation. Ninety-nine (91%) had sufficient initial information to begin investigation and are described here. The mean age was 8 years (range, 6 months–17 years) and 38% were female. Median number of days between vaccination and symptom onset was 2 (range, −11 days to +41 days). Receipt of inactivated, live attenuated, or unknown type of 2009 H1N1 vaccines was reported by 68, 26 and 5 cases, respectively. Serious AEFI were categorized as neurologic events in 47 cases, as hypersensitivity in 15 cases and as respiratory events in 10 cases. At the time of evaluation, recovery was described as complete (61), partial (16), no improvement (1), or unknown (21). Causality assessment yielded the following likelihood of association with 2009 H1N1 vaccination: 8 definitely; 8 probably; 21 possibly; 43 unlikely; 17 unrelated; and 2 unclassifiable. Conclusions: Most AEFI in children evaluated were not causally related to vaccine and resolved without sequelae. Detailed clinical assessment of individual serious AEFI can provide reassurance of vaccine safety.

Facial nerve palsy including Bell's palsy: Case definitions and guidelines for collection, analysis, and presentation of immunisation safety data.

acial nerve palsy including Bell’s palsy: Case definitions and uidelines for collection, analysis, and presentation of immunisation afety data arbara Ratha, Jane F. Gidudub, Helen Anyoti c, Brigid Bollwegb, Patrick Caubeld, eoung-Hwang Chene, David Cornblath f, Rohini Fernandopulleg, Louis Friesh, ochem Galamai, Neville Gibbs j, Gualtiero Grilli k, Patrick Groganl, Katharina Hartmannm, lrich Heiningern, Michael J. Hudsono, Hector s. Izurieta j, Indira Jevajip, iltshire M. Johnsonq, James Jonesb, Brigitte Keller-Stanislawski r, Jerome Kleins, atrin Kohlb, Panagiotis Kokotis t, Yulin Lin, Thomas Linderu, James Oleskev, eorgina Richardw, Tarek Shafshakx, Michael Vajdyy, Virginia Wongz, ames Sejvarb,∗, for the Brighton Collaboration Bell’s Palsy Working Group