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Pharmacovigilance in the Post-COVID-19 World


Given that much of the world is facing the challenge of a third wave (France, Germany, Japan, Korea, Spain) or even still the first wave (India, the US), it requires a degree of ‘blue-sky thinking’ to contemplate what a post-COVID-19 world will look like – even though the first vaccines are now being widely administered to populations outside the clinical trial setting in several countries (including the UK and the US). As with any prediction, unless one is either lucky, a gifted visionary, or, indeed, both, the further into the future one goes, the less accurate the forecast is likely to be. With that caveat, I would like to suggest a few themes that I think it is reasonable to expect will feature in this new, post-pandemic landscape – which I will place, a tad optimistically perhaps, in the first half of 2022.

In order to reach this position, there will have to be an effective vaccine – or, rather more likely, several effective vaccines – which will have been administered to very many people in most of the world. This is likely to have a significant impact on pharmacovigilance globally, both in terms of the number of reports, which will foreseeably arise from the vaccine’s administration itself, and because most, if not all, other reports of (suspected) adverse drug reactions will necessarily involve the COVID-19 vaccine(s) as concomitant medication(s).

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Dr Thomas Leigh is the Head of the medical group within patient safety solutions atCovance. He leads a global team of over 180 physicians and specialist nurses in key locations across the US, Europe, and Asia, that provide expert medical input as part of a comprehensive safety offering to sponsors around the world through their products’ entire lifecycles, encompassing clinical trial and post-marketing/post-approval safety, for drugs, devices, and combination products. Before joining Covance in 2012 as a Safety Physician, Tom worked for the MHRA, the UK Regulatory Authority, as a Medical Assessor and Unit Manager within the Vigilance & Risk Management of Medicines Division (VRMM).
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