Adverse Event
Autoantibodies against Autonomic Nerve Receptors in Adolescent Japanese Girls after Immunization with Human Papillomavirus Vaccine
SYNOPSIS
This preliminary study provides evidence that post-vaccination abnormal autoimmunity plays an important role in the development of unique symptoms after HPV vaccination.
CITATION
SUMMARY
In Japan a significant number of adolescent girls complain of unusual symptoms after human papillomavirus (HPV) vaccination that are considered adverse effects of HPV vaccination. However, a causal link between HPV vaccination and these adverse effects has not been demonstrated. In the present study, we investigated autoantibodies against diverse G-protein coupled receptors in the serum of girls who complained of possible adverse effects after HPV vaccination. This preliminary study provides evidence that post-vaccination abnormal autoimmunity plays an important role in the development of unique symptoms after HPV vaccination.
Adverse events following immunisation (AEFI) reports from the Zimbabwe expanded programme on immunisation (ZEPI): an analysis of spontaneous reports in Vigibase from 1997 to 2017
SYNOPSIS
More than one in ten vaccine-related adverse events in Zimbabwe are serious (11%), and measles-containing vaccines are one of the vaccines most frequently responsible for serious and systemic reactions.
CITATION
SUMMARY
The authors examined passively collected reports of adverse events following immunization (AEFI) in Zimbabwe from 1997 to 2017. Given widespread underreporting to the country’s still-developing vaccine surveillance system, just 272 Individual Case Safety Reports (ICSRs) were available, of which 11% represented “serious events.” Of these, 6% were deaths and 5% were life-threatening or involved prolonged hospitalization. Measles-containing vaccines had the highest AEFI reporting rate and were also strongly associated with serious events, as was a six-component vaccine containing antigens for oral poliovirus, diphtheria, tetanus, pertussis, Haemophilus influenzae type b and hepatitis B (OPV/DTP-Hib-HepB). The majority of AEFI were systemic (versus vaccine site reactions)—and systemic events, again, were associated with measles-containing vaccines.
Investigating the aetiology of adverse events following HPV vaccination with systems vaccinology.
SYNOPSIS
Controversy about alleged adverse events following immunization (AEFI) with HPV vaccine have led to extensive reductions in vaccine acceptance. By making comparisons, authors conclude that any causal links between HPV vaccine and AEFIs, as well as the underlying molecular basis for the links will be revealed and can provide an objective basis for evaluating HPV vaccine safety and for identifying biomarkers for individuals at risk of developing AEFI with HPV vaccination.
CITATION
SUMMARY
In contrast to the insidious and poorly immunogenic human papillomavirus (HPV) infections, vaccination with the HPV virus-like particles (vlps) is non-infectious and stimulates a strong neutralizing-antibody response that protects HPV-naïve vaccinees from viral infection and associated cancers. However, controversy about alleged adverse events following immunization (AEFI) with the vlps have led to extensive reductions in vaccine acceptance, with countries like Japan dropping it altogether. The AEFIs are grouped into chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). In this review, we present a hypothesis that the AEFIs might arise from malfunctions within the immune system when confronted with the unusual antigen. In addition, we outline how the pathophysiology of the AEFIs can be cost-effectively investigated with the holistic principles of systems vaccinology in a two-step process. First, comprehensive immunological profiles of HPV vaccinees exhibiting the AEFIs are generated by integrating the data derived from serological profiling for prominent HPV antibodies and serum cytokines, with data from serum metabolomics, peripheral white blood cells transcriptomics and gut microbiome profiling. Next, the immunological profiles are compared with corresponding profiles generated for matched (a) HPV vaccinees without AEFIs; (b) non-HPV-vaccinated individuals with CFS/ME-like symptoms; and (c) non-HPV-vaccinated individuals without CFS/ME. In these comparisons, any causal links between HPV vaccine and the AEFIs, as well as the underlying molecular basis for the links will be revealed. Such a study should provide an objective basis for evaluating HPV vaccine safety and for identifying biomarkers for individuals at risk of developing AEFI with HPV vaccination.
Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting
SYNOPSIS
The odds of a VAERS report submission during the implementation period were 30.2 times greater than the odds during the comparable preimplementation period when an open-source, electronic health record–based clinical decision support system is used.
CITATION
SUMMARY
Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting.
In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2%) messages, responded to 209 (15.1%), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95% confidence interval, 9.52–95.5) times greater than the odds during the comparable preimplementation period.
An investigation of infant deaths following initial hepatitis B vaccination based on the Vaccine Adverse Event Reporting System (VAERS), 1992-2002
SYNOPSIS
Neonatal deaths following hepatitis B vaccination should be investigated as possible vaccine-related deaths.
CITATION
Soldatenkova VA, Yazbak FE. Medical Veritas. 2007;4:1414-1421.
SUMMARY
This study argues that all unexpected neonatal deaths occurring after initial hepatitis B vaccination should be systematically investigated. Over one-fifth (22%) of neonatal hepatitis B vaccine injuries reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) from 1992 to 2002 were deaths (38/170) that, in nearly all cases, occurred within hours or days of vaccination. Although most of the deaths were officially classified as sudden infant death syndrome (SIDS) or “unexplained” rather than as vaccine-related deaths, the authors note “a statistically significant increase in [the] proportion of neonatal SIDS since implementation of universal vaccination of newborns against hepatitis B.” The VAERS reports also are suggestive of higher risks for premature, small, or slightly ill infants.
Macrophagic myofasciitis lesions assess long-term persistence of vaccine derived aluminum hydroxide in muscle
SYNOPSIS
French scientists tie aluminum adjuvant in vaccine to macrophagic myofasciitis.
CITATION
R.K. Gherardi, M. Coquet, P. Cherin, L. Belec, P. Moretto, P.A. Dreyfus. Brain, 2001, 124, 1821-1831.
SUMMARY
“Macrophagic myofasciitis (MMF) is an emerging condition of unknown cause, detected in patients with diffuse arthromyalgias and fatigue, and characterized by muscle infiltration by granular periodic acid-Schiff’s reagent-positive macrophages and lymphocytes. Intracytoplasmic inclusions have been observed in macrophages of some patients. To assess their significance, electron microscopy was performed in 40 consecutive cases and chemical analysis was done by microanalysis and atomic absorption spectrometry. Inclusions were constantly detected and corresponded to aluminium hydroxide, an immunostimulatory compound frequently used as a vaccine adjuvant.”