[12 MARKS]A 10-yeаr-оld girl received а dоse оf new conjugаte vaccine. Within 12 hours, she developed a high-grade fever (39.5°C), malaise, and a generalised maculopapular rash. Her parents took her to the emergency department, where she was treated symptomatically and recovered fully within two days. The girl was not on any medication, and no underlying conditions were reported. Laboratory investigations showed no evidence of bacterial or viral infection. A few similar reports have been received nationally following administration of this vaccine. The national pharmacovigilance centre has been requested to assess the causal relationship between the vaccine and the reported adverse event.2.1 Using the key criteria and principles of causality assessment in vaccine safety surveillance, evaluate the likelihood that this vaccine caused the reported adverse event. (7 marks)2.2 Discuss why causality assessment is crucial for vaccine safety surveillance and regulatory decision-making. (5 marks)
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