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[quote=Anonymous]More details on VAERS:

[b]The Vaccine Adverse Event Reporting System (VAERS): An In-Depth Analysis of its Role, Mechanics, Limitations, and Methodological Interpretation in Post-Market Vaccine Safety Surveillance[/b]

https://medtechnews.uk/research-reports/understanding-the-vaccine-adverse-event-reporting-system-vaers-purpose-operations-limitations-and-data-interpretation/

[quote][b]3.3. Data Analysis[/b]

The collected and processed data subsequently undergoes preliminary analysis, designed primarily to detect potential safety signals or trends rather than to establish causality:

[u]Preliminary Screening[/u]: [b]Automated tools and statistical algorithms continuously screen the incoming data for unusual patterns. This often involves comparing the observed frequency of specific adverse events after a particular vaccine to the expected background rate of those events in the unvaccinated population or to the frequency after other vaccines[/b] (see Section 5 for detailed methodologies). [b]This initial screening is highly sensitive, aiming to detect any unusual increases or clusters of events.[/b]

[u]Clinical Review of Serious Reports[/u]: [b]All reports describing serious outcomes (e.g., death, life-threatening events, hospitalizations) are [u]individually reviewed by a team of medical officers, epidemiologists, and clinical specialists from the FDA and CDC.[/u] This in-depth clinical review assesses the medical plausibility of the reported event, considers the patient’s medical history, and evaluates whether additional information or follow-up is warranted.[/b] For fatalities, medical records (e.g., autopsy reports, hospital discharge summaries) are often actively sought and reviewed to determine the most likely cause of death.
Descriptive Epidemiology: Basic descriptive analyses are routinely performed, including calculating frequencies of reported events by vaccine, age group, sex, and time since vaccination. While these descriptive statistics cannot yield incidence rates due to the lack of denominator data, they can highlight temporal associations and demographic concentrations.

[b]3.4. Signal Evaluation and Validation[/b]

The identification of a ‘safety signal’ in VAERS data is merely the starting point for a more extensive and rigorous investigation. A signal, by definition, suggests a potential association, but it does not equate to confirmed causality. The subsequent phase involves a multi-pronged approach to evaluate and, if necessary, validate the detected signal:

[u]Further Investigation[/u]: Once a signal is identified, the FDA and CDC initiate further investigation. This can involve [b]reviewing all available clinical documentation associated with the reported events, consulting external medical experts, and conducting targeted literature reviews to assess existing scientific knowledge about the suspected association.[/b]

[u]Epidemiological Studies[/u]: The most critical step in evaluating a signal involves designing and conducting additional, more robust epidemiological studies. These studies leverage larger, more controlled datasets and methodologies that can assess the strength, consistency, and causality of any observed association. Key examples include:

Vaccine Safety Datalink (VSD): A collaborative project between the CDC and nine integrated healthcare organizations, the VSD monitors vaccine safety in populations of approximately 3% of the U.S. population (about 24 million people). The VSD provides access to comprehensive medical records, including vaccination dates, diagnoses, and demographic data, enabling rapid and robust epidemiological studies, such as cohort and case-control studies, with reliable denominator data (McNeil et al., 2014).

Clinical Immunization Safety Assessment (CISA) Project: This CDC-funded network of vaccine safety experts at medical research centers conducts clinical research, evaluates complex cases of adverse events, and provides expert consultation to clinicians and public health officials on vaccine safety issues. CISA focuses on detailed clinical assessments of individuals who have experienced unusual or severe adverse events following vaccination (CISA Network, 2021).

Case-Control Studies and Cohort Studies: These traditional epidemiological designs are employed to compare the rates of adverse events in vaccinated versus unvaccinated (or differently vaccinated) populations, controlling for potential confounding factors (see Section 5 for further details).

Causality Assessment: The ultimate goal of signal evaluation is to move towards a causality assessment. This is a complex scientific endeavor that considers multiple lines of evidence, including the temporality of the event, biological plausibility, consistency with other studies, and the exclusion of alternative causes. International consensus on causality assessment, such as the Brighton Collaboration criteria, may be utilized for specific adverse events (Brighton Collaboration, 2017).[/quote]
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