COVID-19 top priority for research team

Research / 09 April 2021

Photo: UMC

UMC’s head of pharmacovigilance science, Pinelopi Lundquist joined the organisation in mid-2020. She is a clinical pharmacist with a PhD in pharmacokinetics and came to UMC from the Swedish Medical Products Agency, where she managed the unit of medicinal products in use. We checked in with Pinelopi to catch up with her team’s current research priorities. 

At UMC, our pharmacovigilance science agenda is guided by a concise statement: We explore observational medical data to identify and describe harm related to the use of medicines, primarily through signal detection and assessment. However, it would be no surprise to anyone that our current guiding statement is even more concise – pharmacovigilance related to COVID-19 vaccines is our top priority. Within that scope, we have three ongoing activities.

Descriptive analyses – Since the pandemic started, there has been great uncertainty about how the response would develop. We didn’t know, for example, how quickly we would start receiving large numbers of reports on adverse events related to the COVID-19 vaccines. As it happens, the flow of reports is increasing rapidly.

At the start of January 2021, we had just 40 reports, while by 7 April, there were around 443,000. So far, we have prepared three reports with descriptive analyses for vaccines, which we have shared in VigiLyze and with WHO. These monthly reports have been of great value because they give an overview of the adverse events that have been reported. It’s important to note that these reports are for descriptive purposes only, intended for WHO and the national pharmacovigilance centres. It is not possible to draw any conclusions from these reports about associations between a vaccine and an increased risk of a certain outcome. That would require further investigation, including detailed clinical review of the cases involved.

Signal detection – As always, we strive for high impact signals that stimulate further evaluation and research and, when appropriate, raise awareness with patients and health professionals. Our role is to complement the work of other organisations, exploring new approaches to signal detection and assessment and looking for new types of signals, especially clinical patterns or syndromes and risk factors. We will not replicate the work of large regulatory authorities and pharmaceutical companies, who may have more timely and detailed individual case reports. In other words, we prioritise quality over quantity, exploring the most important signals in greater depth. It’s also appropriate for us to focus on low- and middle-income countries and preliminary vaccines signals that are not already being assessed by the bigger regulators. Right now, we are conducting a series of “mini-sprints”, followed up with rapid in-depth assessment when needed, to maintain high quality.

Methods development – In addition to our existing methodology, we have recently added a new approach, based on collecting coherent reports – those that share groups of preferred terms rather than the traditional drug-event combinations. By looking for patterns or syndromes, we believe we can produce more insightful results than by simply looking for individual symptoms. One of our research teams will now shift its primary focus from method refinement and implementation to COVID-19 vaccines signal detection. Their aim is to identify clinical patterns as soon as possible, both expected and potentially unexpected. This new method is particularly exciting, and we hope to discuss it in a lot more detail in a future article.

Pinelopi Lundquist
Head of Pharmacovigilance Science, UMC

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