Drug Safety Matters

#9 Keeping vaccines safe – Helena Sköld & Annette Rudolph


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With COVID-19 vaccinations rolling at full speed in many countries, there’s a lot of talk about vaccine safety monitoring. But what exactly does that mean and how should we be interpreting data on side effects? Uppsala Monitoring Centre’s Helena Sköld and Annette Rudolph walk us through the basics of vaccine pharmacovigilance.

Tune in to find out:

  • How suspected side effects are reported and studied around the world
  • Why a mere list of reported side effects says little about a vaccine’s safety profile
  • How a global database like VigiBase can help spot unexpected safety issues

Want to know more?

Media coverage can greatly affect the rate at which side effects of medicines and vaccines are reported, as shown by this study by the New Zealand Centre for Adverse Reactions Monitoring.

When talking about side effects of any medicine or vaccine, it’s important not to confuse reporting rates with incidence.

In its COVID-19 vaccine safety surveillance manual, the World Health Organization (WHO) outlines how countries should prepare for the introduction of COVID-19 vaccines.

Uppsala Monitoring Centre (UMC) has developed guidelines for carrying out pharmacovigilance work during the COVID-19 pandemic and a list of frequently asked questions on suspected side effects of COVID-19 vaccines.

Among other things, UMC has been supporting members of the WHO Programme for International Drug Monitoring in their vaccine safety surveillance efforts by improving the VigiLyze and VigiFlow tools.


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About UMC
Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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