Methods of ensuring vaccine safety
Expert Review of VaccinesPublished 1 August 2002
Robert Ball
Citations24
SJR quartileQ1
SJR score1.25
SNIP0.98
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
Investment in resources to identify true adverse effects, understand their pathophysiology, and design and manufacture safer vaccines is needed to ensure the safety of vaccines.
Abstract
With a decreasing disease burden from vaccine-preventable diseases in developed countries, ensuring the safety of vaccines is critically important for maintaining public confidence in vaccination programs and continuing low levels of disease. This will require investment in resources to identify true adverse effects, understand their pathophysiology, and design and manufacture safer vaccines.
Keywords
Social SciencesMedicine
Journal of the Royal Society of MedicineThe environment and disease: association or causation?
7,311 Citations2015Austin Bradford Hill
The objects of this newly founded Section of Occupational Medicine are to provide a means, not readily afforded elsewhere, whereby physicians and surgeons with a special knowledge of the relationship between sickness and injury and conditions of work may discuss their problems, not only with each other, but also with colleagues in other fields, by holding joint meetings with other Sections of the Society.
Pharmacoepidemiology and Drug SafetyUse of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports
1,730 Citations2001Stephen Evans, Patrick Waller +1 more
The process of generating ‘signals’ of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack but statistical approaches to the data have been underutilised.
New England Journal of MedicineIntussusception among Infants Given an Oral Rotavirus Vaccine
976 Citations2001Trudy V. Murphy, Paul Gargiullo +11 more
The strong association between vaccination with RRV-TV and intussusception among otherwise healthy infants supports the existence of a causal relation.
The American StatisticianBayesian Data Mining in Large Frequency Tables, with an Application to the FDA Spontaneous Reporting System
770 Citations1999William DuMouchel
Here, a baseline or null hypothesis expected frequency is constructed for each cell, and screening criteria for ranking the cell deviations of observed from expected count are suggested and compared.
New England Journal of MedicineThe Guillain–Barré Syndrome and the 1992–1993 and 1993–1994 Influenza Vaccines
503 Citations1998Tamar Lasky, Gina J. Terracciano +9 more
There was no increase in the risk of vaccine-associated Guillain-Barré syndrome from 1992-1993 to 1993-1994 and for the two seasons combined, the adjusted relative risk of 1.7 suggests slightly more than one additional case of Guillian-B Barré syndrome per million persons vaccinated against influenza.
New England Journal of MedicineVaccinations and the Risk of Relapse in Multiple Sclerosis
487 Citations2001Christian Confavreux, Samy Suissa +3 more
Vaccination does not appear to increase the short-term risk of relapse in multiple sclerosis, and reports of 94 percent of these vaccinations were confirmed.
VaccineThe vaccine adverse event reporting system (VAERS)
485 Citations1994Robert T. Chen, S RASTOGI +5 more
New England Journal of MedicineHepatitis B Vaccination and the Risk of Multiple Sclerosis
431 Citations2001Alberto Ascherio, Shumin M. Zhang +5 more
A nested case-control study in two large cohorts of nurses in the United States indicates no association between hepatitis B vaccination and the development of multiple sclerosis.
BMJMumps, measles, and rubella vaccine and the incidence of autism recorded by general practitioners: a time trend analysis
394 Citations2001James A. Kaye, Maria del Mar Melero-Montes +1 more
Evidence is provided that no correlation exists between the prevalence of MMR vaccination and the rapid increase in the risk of autism over time, and the explanation for the marked increase in risk of the diagnosis of autism in the past decade remains uncertain.
PEDIATRICSVaccine Safety Datalink Project: A New Tool for Improving Vaccine Safety Monitoring in the United States
345 Citations1997Robert T. Chen, John W. Glasser +14 more
Preliminary design, data collection, and analytic capability of the Vaccine Safety Datalink project has been validated by replication of previous known associations between seizures and DTP and MMR vaccines.
PEDIATRICSAn Assessment of Thimerosal Use in Childhood Vaccines
341 Citations2001L. Ball, Robert Ball +1 more
No evidence of harm caused by doses of thimerosal in vaccines, except for local hypersensitivity reactions is revealed, however, some infants may be exposed to cumulative levels of mercury during the first 6 months of life that exceed EPA recommendations.
New England Journal of MedicineThe Risk of Seizures after Receipt of Whole-Cell Pertussis or Measles, Mumps, and Rubella Vaccine
320 Citations2001William E. Barlow, Robert L. Davis +17 more
There are significantly elevated risks of febrile seizures on the day of receipt of DTP vaccine and 8 to 14 days after the receipt of MMR vaccine, but these risks do not appear to be associated with any long-term, adverse consequences.
Drug SafetyPrinciples of Signal Detection in Pharmacovigilance
233 Citations1997Ronald H.B. Meyboom, Toine C. G. Egberts +4 more
A proposal is made for a standard signal management procedure at pharmacovigilance centres, including the following steps: signal delineation, literature search, preliminary inventory of data, collection of additional information, consultation with the World Health Organization Centre for International Drug Monitoring and the relevant drug companies, aggregated data assessment and a report in writing.
The Pediatric Infectious Disease JournalPopulation-based study of rotavirus vaccination and intussusception
225 Citations2001Piotr Kramarz, Eric K. France +10 more
A retrospective cohort study in ten managed care organizations found that RRV-TV is associated with an increased risk of intussusception, and the risk is greatest 3 to 7 days after the first vaccination dose.
National Academies Press eBooksAdverse Events Associated with Childhood Vaccines
215 Citations1994Institute of Medicine
This volume provides the most thorough literature review available about links between common childhood vaccines--tetanus, diphtheria, measles, mumps, polio, Haemophilus influenzae b, and hepatitis B--and specific types of disorders or death.
JAMAPostlicensure Safety Surveillance for Varicella Vaccine
214 Citations2000Robert P. Wise
Although the role of varicella vaccine remained unproven in most serious adverse event reports, there were a few positive rechallenge reports and consistency of many cases with syndromes recognized as complications of naturalvaricella.
American Journal of Public HealthThe reporting sensitivities of two passive surveillance systems for vaccine adverse events.
202 Citations1995Steven J. Rosenthal, R Chen
The significant underreporting of known outcomes, together with the nonspecific nature of most adverse event reports, highlights the limitations of passive surveillance systems in assessing the incidence of vaccine adverse events.
VaccineAn overview of the vaccine adverse event reporting system (VAERS) as a surveillance system
170 Citations1999James A. Singleton
The Vaccine Adverse Event Reporting System (VAERS), the spontaneous reporting system for vaccine-associated adverse events in the United States, is evaluated as a public health surveillance system using evaluation guidelines from the Centers for Disease Control and Prevention.
PubMedThe Vaccine Safety Datalink: immunization research in health maintenance organizations in the USA.
152 Citations2000Robert T. Chen, Frank DeStefano +9 more
The Vaccine Safety Datalink has proved to be a valuable resource providing important information on a number of vaccine safety issues, and provided opportunities to address vaccination coverage, cost-effectiveness and other matters connected with immunization as well as matters outside this field.
Emerging infectious diseasesAdvanced Age a Risk Factor for Illness Temporally Associated with Yellow Fever Vaccination
143 Citations2001Michael A. Martin, Leisa Weld +6 more
It is found that the rate of reported adverse events among elderly vaccinees was higher than among vaccinees 25 to 44 years of age, and two additional deaths among elderly YF vaccinees are found, suggesting enhanced surveillance is needed.
PubMedThe complicated task of monitoring vaccine safety.
138 Citations1997S S Ellenberg, Robert T. Chen
A continual effort to monitor data effectively and to develop more precise ways of assessing risks of vaccines is necessary to ensure public confidence in immunization programs.
VaccineInfluenza vaccination in children with asthma in Health Maintenance Organizations
129 Citations2000Piotr Kramarz, Frank DeStefano +9 more
Vaccination coverage in asthmatic children could be increased by taking advantage of all opportunities to vaccinate children with asthma whenever they make clinic visits in the fall and early winter.
Pharmacoepidemiology and Drug SafetyThe Vaccine Safety Datalink project
128 Citations2001Frank DeStefano
The Vaccine Safety Datalink has proven to be a valuable resource that has provided important information on a number of vaccine safety issues and has also provided opportunities to address other immunization questions including vaccination coverage and cost‐effectiveness.
Archives of Pediatrics and Adolescent MedicineMeasles-Mumps-Rubella and Other Measles-Containing Vaccines Do Not Increase the Risk for Inflammatory Bowel Disease<subtitle>A Case-Control Study From the Vaccine Safety Datalink Project</subtitle>
124 Citations2001Robert L. Davis
Vaccination with MMR or other MCV, or the timing of vaccination early in life, did not increase the risk for IBD and risk for Crohn's disease, ulcerative colitis, or IBD was not elevated in the time immediately following vaccination with either vaccine.
VaccineAdverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States
121 Citations2000Hiroshi Takahashi, Vitali Pool +2 more
Passively collected VAERS surveillance data indicate that characteristic hypersensitivity reactions with a delayed onset continue to occur among JEV recipients and that conservative recommendations limiting its use to travelers at high risk of infection with Japanese encephalitis are appropriate.
PEDIATRICSChildhood Vaccinations, Vaccination Timing, and Risk of Type 1 Diabetes Mellitus
121 Citations2001Frank DeStefano, John P. Mullooly +10 more
This is the first epidemiologic study to evaluate the possibility that timing of vaccination is related to risk of clinical diabetes in children, and the results are generally in agreement with previous studies in not finding any increased risks.
PEDIATRICSIntussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System
114 Citations2001Lynn R. Zanardi, Penina Haber +4 more
Using a passive surveillance system for vaccine adverse events, at least a fourfold increase over the expected number of intussusception cases occurring within 1 week of receipt of rotavirus vaccine is observed.
JAMARisk of Chronic Arthropathy Among Women After Rubella Vaccination
106 Citations1997Paula Ray
The data support the continued vaccination of rubella-susceptible women to reduce the risk of congenital rubella syndrome and there was no evidence of any increased risk of new onset chronic arthropathies or neurologic conditions in women receiving the RA 27/3 rubella vaccine.
Archives of Family MedicineDoes Influenza Vaccination Exacerbate Asthma?: Analysis of a Large Cohort of Children With Asthma
103 Citations2000Piotr Kramarz
It is found that influenza vaccination does not result in acute asthma exacerbations in children, and concern about possible exacerbation of asthma is not a valid reason to not vaccinate children with asthma against influenza.
JAMAHair Loss After Routine Immunizations
100 Citations1997Robert P. Wise
There may be an association, probably very rare, between vaccinations and hair loss, and more than 1 pathophysiologic mechanism may be responsible.
Archives of Pediatrics and Adolescent MedicineSyncope After Immunization
98 Citations1997M. Miles Braun
Patients exhibiting presyncopal signs and symptoms around the time of immunization need to be evaluated carefully and may needs to be assisted to sit or lie down after immunization until free of symptoms.
PubMedMonitoring signals for vaccine safety: the assessment of individual adverse event reports by an expert advisory committee. Advisory Committee on Causality Assessment.
94 Citations2000Jean‐Philippe Collet, Noni E. MacDonald +2 more
A standardized evaluation instrument developed for use by an expert advisory committee to facilitate the process of assessing the more serious cases of adverse reaction reported to vaccination has proven useful in evaluating ongoing safety of vaccines in Canada.
VaccineAdverse event reports following vaccination for Lyme disease: December 1998–July 2000
92 Citations2002Sarah Lathrop, Robert Ball +7 more
Based on reporting to VAERS, there were no unexpected or unusual patterns of reported adverse events following Lyme disease vaccine administration, other than hypersensitivity reactions, compared with adverse events observed in clinical trials of this vaccine.
PEDIATRICSHypotonic–Hyporesponsive Episodes Reported to the Vaccine Adverse Event Reporting System (VAERS), 1996–1998
88 Citations2000Tracy S. DuVernoy, M. Miles Braun +1 more
This study represents the largest published case series of children with HHE and supports the generally benign, self-limited, nonrecurrent nature of this syndrome.
VaccineData mining in the US Vaccine Adverse Event Reporting System (VAERS): early detection of intussusception and other events after rotavirus vaccination
84 Citations2001Manette T. Niu, Diane Erwin +1 more
The utility of data mining to detect significant vaccine-associated events at early date is demonstrated and data mining appears to be an efficient and effective computer-based program that may enhance early detection of adverse events in passive surveillance systems.
The Pediatric Infectious Disease JournalSTEVENS-JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS AFTER VACCINATION: REPORTS TO THE VACCINE ADVERSE EVENT REPORTING SYSTEM
84 Citations2001Robert Ball, L. Ball +4 more
Six cases of SJS or TEN after vaccination without other obvious triggers are identified, suggesting that SJS and TEN might very rarely be caused by vaccination.
The Pediatric Infectious Disease JournalTHROMBOCYTOPENIA AFTER IMMUNIZATION WITH MEASLES VACCINES: REVIEW OF THE VACCINE ADVERSE EVENTS REPORTING SYSTEM (1990 TO 1994)
84 Citations1996Judy A. Beeler, Frederick Varricchio +1 more
PEDIATRICSMMR2 Immunization at 4 to 5 Years and 10 to 12 Years of Age: A Comparison of Adverse Clinical Events After Immunization in the Vaccine Safety Datalink Project
82 Citations1997Robert L. Davis, Edgar K. Marcuse +8 more
The results suggest that the risk for clinical events after MMR2 immunizations is greater in the 10- to 12-year age group.
The Pediatric Infectious Disease JournalRisk of hospitalization because of aseptic meningitis after measles-mumps-rubella vaccination in one- to two-year-old children: an analysis of the Vaccine Safety Datalink (VSD) Project
73 Citations1997Steven Black, Henry R. Shinefield +16 more
It is reassuring that in this evaluation no increased risk of aseptic meningitis after MMR vaccine was found, and review of validated hospitalized cases during the observation period did not reveal evidence of an increased risk.
Archives of Disease in ChildhoodRe-vaccination of 421 children with a past history of an adverse vaccine reaction in a special immunisation service
69 Citations2000Michael Gold
Re-vaccination of children who have a past history of an AEFI appears safe, and a special immunisation service should be part of a comprehensive immunisation programme.
Journal of Clinical EpidemiologyComparative Safety of Two Recombinant Hepatitis B Vaccines in Children
67 Citations1998Manette T. Niu, Philip Rhodes +7 more
This study demonstrates the dual roles played by VAERS and VSD in providing a more complete picture of the post-marketing safety profile of childhood vaccines, and underscores the importance of using other analytic studies to evaluate findings from passive surveillance systems of adverse events.
Current Opinion in BiotechnologyThe regulation of DNA vaccines
61 Citations2001Herbert A. Smith, Dennis M. Klinman
The framework for regulating DNA vaccines has been in place since the first clinical trial was initiated in the mid-1990s and has evolved on the basis of insights provided by ongoing preclinical and clinical studies, including analyses of the safety of DNA vaccines in normal volunteers, and recent data concerning the tissue distribution, persistence, and integration potential of DNA plasmids.
PEDIATRICSInterleukin-6, C-Reactive Protein, and Abnormal Cardiorespiratory Responses to Immunization in Premature Infants
61 Citations1998Massroor Pourcyrous, Sheldon B. Korones +2 more
The frequency of cardiorespiratory difficulty and its occasional severity suggest a need to monitor premature infants for ∼48 hours after routine immunization, and demonstrates clearly the temporal relationship between IL-6 and CRP increments after DTwP, Hib, HBV, and IPV vaccines.
Drug SafetyMonitoring the Safety of Vaccines
57 Citations2002Susan S. Ellenberg, M. Miles Braun
The combination of passive surveillance and more structured case-control or cohort studies possible in the VSD has helped to both identify new vaccine risks and to provide reassuring evidence of lack of risk in other situations where concerns have been raised.
Pharmacoepidemiology and Drug SafetySafety of anthrax vaccine: a review by the Anthrax Vaccine Expert Committee (AVEC) of adverse events reported to the Vaccine Adverse Event Reporting System (VAERS)
57 Citations2002John L. Sever, Alan I. Brenner +4 more
To assess the safety of a licensed anthrax vaccine given to nearly 400 000 US military personnel, reports of adverse events submitted to the Vaccine Adverse Event Reporting System (VAERS) were reviewed and evaluated medically.
The Journal of Infectious DiseasesIn Vivo Synthesis of Tumor Necrosis Factor‐α in Healthy Humans after Live Yellow Fever Vaccination
57 Citations1998Ulrich Hacker, Tomáš Jelı́nek +5 more
Plasma samples of 15 healthy subjects taken before and until day 2 (until day 11 in 5 of these subjects) after yellow fever vaccination, showed a significant increase of plasma TNF concentration on day 2 after vaccination and a second peak on day 7.
The Pediatric Infectious Disease JournalRecombinant hepatitis B vaccination of neonates and infants: emerging safety data from the Vaccine Adverse Event Reporting System
55 Citations1996Manette T. Niu, David M. Davis +1 more
No unexpected adverse events in neonates and infants given HB vaccine despite use of at least 12 million doses of vaccine given in these age groups are shown, showing the postmarketing safety of recombinant hepatitis B vaccine.
The Journal of PediatricsDescriptive epidemiology of adverse events after immunization: Reports to the Vaccine Adverse Event Reporting System (VAERS), 1991-1994
54 Citations1997M. Miles Braun, Susan S. Ellenberg
The peak age of deaths at ages 1 to 3 months could be expected on the basis of prior studies showing that sudden infant death syndrome deaths peak at that age, and that most deaths in the Vaccine Adverse Event Reporting System are attributed to sudden infants death syndrome.
JAMAUS Immunization Policy
51 Citations2002Jon S. Abramson
The benefits of the vaccines in the recommended childhood immunization schedule are highlighted, the known risks of vaccinations are discussed, some of the current impediments to a maximally effective national immunization program are explored, and challenges that lie ahead are discussed.
The Journal of Infectious DiseasesHLA‐DR Class II Associations with Rubella Vaccine‐Induced Joint Manifestations
45 Citations1998Leslie A. Mitchell, Aubrey J. Tingle +5 more
HLA class II (HLA-DR) frequencies were examined in relation to incidence of acute arthralgia or arthritis in 283 white women who had received RA27/3 rubella vaccine or placebo postpartum, suggesting that coexpression of these specificities may predispose to post partum arthropathy.
The Journal of Infectious DiseasesThe Mumps Virus Neurovirulence Safety Test in Rhesus Monkeys:A Comparison of Mumps Virus Strains
44 Citations1999Steven A. Rubin, Philip Snoy +5 more
A trend of higher neurovirulence scores was observed in monkeys inoculated with wild type mumps virus versus vaccine strains, although differences were not statistically significant, indicating the need for further examination and refinement of the MNVT.
Journal of Clinical EpidemiologyDevelopment of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the Vaccine Adverse Event Reporting System
43 Citations2002Robert Ball, Neal A. Halsey +7 more
It is shown that it is possible to develop reproducible case definitions for acute encephalopathy, encephalitis, and multiple sclerosis using a standardized approach and application of standardized case definitions to VAERS reports documents the limited information in many reports, specifies data for supplemental collection, and indicates thatVAERS reports should be cautiously interpreted.
Pharmacoepidemiology and Drug SafetySafety considerations for new vaccine development
42 Citations2001Susan S. Ellenberg
Information would increase confidence in the safety of vaccines, be a valuable resource for assessing spontaneous reports of adverse events after licensure, and would reduce the risk of licensing a new vaccine that had the potential to cause severe injury to a small proportion of vaccinees.
PubMedDeveloping a national system for dealing with adverse events following immunization.
41 Citations2000Ushma Mehta, Julie B. Milstien +2 more
A simple national system for dealing with vaccine safety and with emergencies as they arise is described and the goals of a training programme designed to help develop such a system are outlined.
National Academies Press eBooksImmunization Safety Review
37 Citations2002Institute of Medicine
The Immunization Safety Review Committee reviewed the evidence regarding the hypothesis that multiple immunizations increase the risk for immune dysfunction and found that the epidemiological evidence favors rejection of a causal relationship between multiple immunization and increased risk for infections and for type 1 diabetes.
Pharmacoepidemiology and Drug SafetyThe epidemiology of fatalities reported to the Vaccine Adverse Event Reporting System 1990–1997
36 Citations2001L. Silvers, Susan S. Ellenberg +4 more
To examine the fatalities reported to the federally administered Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, in its first 7 years, it is suggested that children under the age of five are most at risk of adverse events.
VaccineLessons learned concerning vaccine safety
34 Citations2001Stanley A. Plotkin
The author argues that despite what may seem a waste of energy, most proposed relationships between vaccines and reactions must be thoroughly investigated, as some have been proved correct.
Annals of NeurologyAssociation of HLA and T-cell receptor gene polymorphisms with Semple rabies vaccine-induced autoimmune encephalomyelitis
29 Citations1999Sucheep Piyasirisilp, Barbara J. Schmeckpeper +3 more
Genetic susceptibility associated with MHC class II alleles may have a role in the pathogenesis of SAE and its mechanism may be different from those involved in multiple sclerosis.
Clinical Infectious DiseasesSafety Data on Meningococcal Polysaccharide Vaccine from the Vaccine Adverse Event Reporting System
26 Citations2001Robert Ball, M. Miles Braun +2 more
That there were few reports of serious adverse events, with >6 million doses having been distributed, and no clear signal of a previously unrecognized serious reaction is reassuring with regard to the safety of meningococcal vaccine.
Determining Causation from Case Reports
19 Citations2006Judith K. Jones
Pediatric NeurologyAdverse events following immunization: Assessing probability of causation
16 Citations1989Gerald M. Fenichel, David A. Lane +4 more
A method to assess causation of serious neurologic events by probability theory is developed, combining epidemiologic information on disease incidence with specific elements of the patient history so that an estimate of the odds of vaccine causation can be derived.
VaccineEvidence based vaccinology
16 Citations2002David R. Nalin
The rationale for EBV is that the highest evidentiary standards are required to maintain a rigorous scientific basis of vaccine quality control in manufacture and to ensure valid determination of vaccine efficacy, field effectiveness and safety profiles (including post-licensure safety monitoring), cost-benefit analyses, and risk:benefit ratios.
Clinical Infectious DiseasesPerspectives on the Design and Analysis of Prelicensure Trials: Bridging the Gap to Postlicensure Studies
16 Citations2001Steven Black
The rapid identification of intussusception as a complication of rotavirus vaccination should not be seen as a failure of prelicensure studies but rather as a positive example of an effective integrated safety assessment program.
Clinical Infectious DiseasesEvaluating the Safety of Combination Vaccines
16 Citations2001Susan S. Ellenberg
The development of combination vaccines is important to facilitate protection of people from potentially life-threatening infectious diseases and controlled safety studies are needed to determine reliably whether risks are increased compared with administration of individual components.
British Journal of Clinical PharmacologyLive attenuated polio vaccine and the risk of intussusception
15 Citations2001Hershel Jick, Catherine Vasilakis‐Scaramozza +1 more
There is no suggestion that oral polio vaccine increases the risk for intussusception, according to a nested case-control analysis based on data from the General Practice Research Database.
Pharmacoepidemiology and Drug SafetyPharmacogenetics and pharmacoepidemiology
14 Citations2001Judith K. Jones
This paper seeks to stimulate consideration of the short‐ and long‐term possibilities raised by research into pharmacogenetics and pharmacoepidemiology, to identify potential tissue databanks linked to population data, and to summarize ethical responsibilities.
PubMedReview of current preclinical testing strategies for bacterial vaccines.
6 Citations1998L A Falk, D K Chandler +1 more
Preclinical data should support the proposed clinical formulation and include detailed information on the source and quality of starting materials, manufacturing processes, characterization of bacterial seed stocks, potency, general safety, purity, and identity.
