What is a Safety Signal and Why Does It Matter?

Ramesh Thakur

… In this article I want to look specifically at the concept of “safety signals” because I don’t believe the significance of this concept in medical science and public health interventions is widely understood in the general public.

… A safety signal does not in and of itself establish a direct causal relationship between a medicine and any side effect. But it does generate “a hypothesis that, together with data and arguments, justifies the need” for an evaluation of “what is called causality assessment.”

… The deliberate blind eye turned to the lagged temporal correlation between vaccine uptake and all-cause excess mortality is married to the focus on population-wide statistics instead of the age-segregated data for a disease whose burden shows a steep age gradient.

… My final question is to the public health clerisy. If you become transparent on efficacy, investigate safety signals urgently and fully and publish the findings honestly: In the long run, will your credibility worsen, or will you begin to regain public trust and confidence?

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