Blog: Roundup of DSRU research on Covid-19 vaccines and treatments

Since the beginning of the Covid-19 pandemic, we have conducted multiple studies to monitor the safety of Covid-19 vaccines. The DSRU is a small, nimble research unit, so we were able to react quickly at the onset of the pandemic and prioritise research into Covid-19 treatments and vaccines.

Early in the pandemic many existing medicines were proposed as treatments for Covid-19 while pharma companies and research labs rushed to find and develop new treatments and vaccines. We conducted living benefit/risk evaluations on the key early repurposed treatments, including  chloroquine and hydroxychloroquine, remdesivir, lopinavir/ ritonavir and convalescent plasma. We also published a collaborative paper on repurposing drugs to treat Covid-19.

As one-by-one Covid-19 vaccines were approved for use in the UK and across Europe, we were involved in a number of studies which between them examined the safety of all the UK vaccines. These included a Post-Authorisation Safety Study (PASS) on the AstraZeneca Covid-19 vaccine, which we designed using active surveillance methodology and set up in record time soon after the vaccine was approved in the UK. Through our membership of VAC4EU (Vaccine monitoring Collaboration for Europe) we are conducting the UK arm of collaborative PASS studies on the AstraZeneca, Moderna and Pfizer Covid-19 vaccines, using CPRD (Clinical Practice Research Datalink) data. The DSRU also set up and ran the UK arm of the “Cohort Event Monitoring of safety of Covid-19 vaccines” study led by the Netherlands Pharmacovigilance Centre, Lareb, in which vaccinees recruited to the study provided data on potential adverse reactions via a dedicated app at intervals following vaccination.  Most of these studies are still underway as we seek to study the longer-term safety of the vaccines.

As rare side effects of Covid-19 vaccines began to emerge, we became involved in further studies to find out more. We are using CPRD data to investigate myocarditis and pericarditis following Covid-19 vaccines. We are also running the UK arm of the self-controlled case series study of Covid-19 vaccines and myocarditis/ pericarditis, Guillain-Barré and vaccine-induced Immune Thrombotic Thrombocytopenia (VITT) after Covid-19 vaccination. This is part of the Global Covid Vaccine Safety Project led by the Global Vaccine Data Network. We have also conducted systematic reviews on myocarditis and pericarditis following mRNA Covid-19 vaccination and  myocarditis and pericarditis in transplant recipients and immunocompromised patients. In addition, we have examined spontaneously reported data to understand cases of VITT.

With pharmacovigilance in the spotlight and to further improve patient safety during the pandemic, the DSRU also published conceptual papers to aid and facilitate transparency about the process of examining the safety of vaccines during the pandemic. These included how to investigate serious adverse events in clinical trials and the importance of postmarketing studies.

In addition, the DSRU regularly posted updates regarding topical Covid-19 vaccine issues on its Global Pharmacovigilance Observatory webpage, with the aim of collating all available evidence surrounding adverse events observed following Covid-19 vaccination into one place, to provide a cohesive message about vaccine safety.

As the UK’s leading pharmacovigilance and pharmacoepidemiology unit, we are proud to have contributed to the response to the Covid-19 pandemic by monitoring the safety of treatments and vaccines and thus helping to protect public health. We are very grateful to our skilled close-knit team who have worked exceptionally hard since 2020 on these Covid-19 research projects.

Dr Liz Lynn