Use of CPRD data to monitor the safety of COVID-19 vaccines

  • The DSRU is collaborating with several other research institutions throughout Europe, under the VAccine monitoring Collaboration for Europe (VAC4EU) study network.
  • This independent network is conducting post-authorisation safety studies (PASS) for each of the COVID-19 vaccines marketed throughout Europe, to fulfil regulatory requirements set out by the European Medicines Agency (EMA).
  • The DSRU forms the UK arm of this international group.
  • We are using electronic primary healthcare record data from CPRD Aurum to monitor the safety of COVID-19 vaccines, contributing to studies on COVID-19 vaccines manufactured by Pfizer/BioNTech, AstraZeneca, and Moderna.
  • Each of these studies is monitoring the frequency of adverse events of special interest (AESI).
  • We use de-identified CPRD data to form cohorts of patients who have and have not received the COVID-19 vaccine of interest. We then use the medical records to search for those who have developed an AESI in each group. We compare the frequency of AESI within vaccinated individuals with the frequency of these events in unvaccinated patients.
  • In the Moderna vaccine study, there is also a signal detection step. Incidence rates of AESI are compared with pre-pandemic background event rates. This highlights any adverse events occurring within vaccinated individuals which are yet to be characterised.
  • Aggregate results from the UK arm are combined with aggregate results from the other research partners. The use of CPRD data in this way contributes to an overall picture of vaccine safety within Europe.
  • Regular interim reports are provided to the EMA, enabling the regulators to monitor the safety of these vaccines on an ongoing basis.
  • The final reports for each of the studies are expected in 2024.