The WHO Algorithm for Causality Assessment of Adverse Effects Following Immunization with Genetic-Based Anti-COVID-19 Vaccines: Pitfalls and Suggestions for Improvement.

The WHO Algorithm for Causality Assessment of Adverse Effects Following Immunization with Genetic-Based Anti-COVID-19 Vaccines: Pitfalls and Suggestions for Improvement.

Publication date: Nov 30, 2024

Clarifying and differentiating the causes of diseases is an essential step in any clinical activity, but it takes on particular relevance and complexity in the case that arise following vaccinations. The WHO has proposed a protocol that uses a list of specific questions about vaccine-related adverse events and an algorithm for making a judgement. Here, we analyze and discuss the important limitations of this protocol when applied to the new genetic-based anti-COVID-19 vaccines, particularly once dealing with rare and unexpected pathological events. The main controversial aspects concern: (a) the prevailing consideration of other possible causes; (b) the biological plausibility and the choice of an appropriate time window to consider adverse effects possibly caused by vaccines; (c) the reference to scientific literature, which may be very limited and often controversial in early stages of introducing new vaccines because of the short period of observation; (d) the final classification of the algorithm into only three classes, which leaves ample space for the “indeterminate” category. Failure to address these issues may lead to distorted pharmacovigilance reports with significant consequences on the benefit/harm assessment. In anticipation of possible future pandemics managed with new vaccines, the WHO algorithm needs to be revised with appropriate protocols for monitoring and evaluation of adverse effects that take into account the novel mechanism of action and real-world epidemiological data.

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Concepts Keywords
Genetic causality assessment
Pathological COVID-19 vaccine
Pharmacovigilance differential diagnosis
Space pharmacovigilance
Vaccine vaccine safety
WHO algorithm

Semantics

Type Source Name
disease IDO algorithm
disease MESH Causality
drug DRUGBANK Coenzyme M
disease MESH COVID 19 pandemic
disease MESH emergency
disease MESH morbidities
disease MESH infection
disease MESH uncertainty
disease MESH thrombosis
disease MESH myocarditis
disease MESH pericarditis
disease MESH vasculitis
disease IDO symptom
disease MESH measles
pathway KEGG Measles
disease MESH mumps
disease MESH rubella
drug DRUGBANK Varicella Zoster Vaccine (Live/Attenuated)
drug DRUGBANK Isoxaflutole
disease IDO intervention
disease MESH adverse drug reaction
disease IDO history
disease MESH hyperpyrexia
disease MESH muscle fatigue
disease MESH arthralgia
disease MESH autoimmunity
disease MESH sudden death
disease MESH rare diseases
disease IDO process
disease MESH death
disease MESH frailties
disease MESH defects
drug DRUGBANK L-Threonine
disease MESH meningoencephalitis
disease MESH convulsions
disease MESH herpes simplex
disease MESH hepatitis
disease MESH rabies
disease IDO immunosuppression
disease MESH latent infection
disease MESH thrombocytopenia
disease MESH syndrome
disease MESH menstrual irregularities
disease IDO immune response
disease MESH hypertension
disease MESH autoimmune diseases
disease IDO blood
disease MESH virus infection
drug DRUGBANK Trestolone
disease MESH tumors
disease MESH allergies
disease MESH dermatitis
disease MESH venous thrombosis
disease MESH numbness
disease MESH tachycardia
disease MESH dyspnea
disease MESH insomnia
disease MESH anxiety
disease IDO site
disease MESH Community transmission
disease MESH viral load
drug DRUGBANK Bismuth subgallate
disease MESH Varicella
disease IDO country
disease MESH Lymphoma
disease MESH Complications
disease MESH Autoimmune Encephalitis
disease MESH Keratitis
disease MESH herpes simplex keratitis
disease MESH Herpes zoster
disease MESH Herpes simplex encephalitis
disease MESH herpesvirus infections
disease MESH Guillain Barre Syndrome
disease MESH Dysautonomia
disease MESH hemophilia
drug DRUGBANK Vorinostat
disease MESH rheumatic diseases
disease MESH inflammation
disease MESH Postural orthostatic tachycardia syndrome
disease MESH Immune thrombocytopenic purpura
disease MESH autoimmune hepatitis
disease MESH Cytokine Storm
disease MESH Venous Thromboembolism
disease MESH acute respiratory distress syndrome
disease MESH Encephalitis
disease MESH lymphoproliferative disorders
disease MESH Sarcoma

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