Published: 27 November 2020
Revised:  10 February 2021

COVID-19

Vaccine Safety Monitoring Process

NOTE: We will update this page as more information becomes available.

How will Medsafe monitor COVID-19 vaccine safety?

Medsafe has not yet finalised all of the methods that we will use to monitor COVID-19 vaccine safety. However, we will base them on our usual safety monitoring methods as summarised below.

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Pharmacovigilance

Medsafe uses a variety of methods to collect information on the safety of vaccines after they have been approved for use. These methods, together with investigation of the information gathered and taking action when appropriate, are known as pharmacovigilance.

Pharmacovigilance involves:

  • monitoring the use of vaccines in everyday practice to identify previously unrecognised adverse drug reactions (side effects) or changes in the patterns of adverse drug reactions
  • seeking other information on the safety of vaccines
  • investigating whether the information gathered suggests there is a new or changed adverse drug reaction
  • assessing the risk of harm and benefits of vaccines, and taking action when required to improve their safe use
  • providing information to healthcare professionals and consumers to promote the safe use of vaccines
  • monitoring the impact of any action taken and assessing whether further action is required.

We use information from many sources for pharmacovigilance, including:

  • clinical and epidemiological studies
  • case reports
  • published medical literature
  • pharmaceutical companies
  • other regulatory authorities such as the Food and Drug Administration (USA), European Medicines Agency (Europe) and Therapeutic Goods Administration (Australia).

In addition, suspected adverse drug reactions (ADRs) to vaccines are reported to the Centre for Adverse Reactions Monitoring (CARM). The Ministry of Health (through Medsafe) contracts the collection of this information to CARM, based at the University of Otago in Dunedin. If CARM detects a possible safety problem with any vaccine, they will inform Medsafe and the Medicines Adverse Reactions Committee.

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Adverse drug reactions (ADRs) – side effects

Normally, we are interested in finding information on adverse drug reactions (ADRs), more commonly called side effects. An ADR is a known undesirable effect caused by a medicine or vaccine. However, for vaccines we are interested in adverse events following immunisation (AEFIs), because ADRs are more difficult to identify. AEFIs are unwanted and sometimes harmful events that can happen after immunisation but do not always mean that the vaccine caused the event.

All vaccines have the potential to cause ADRs in some people. Most are mild and short-lived. However, some vaccines may rarely cause more serious reactions.

The best way to know what the possible ADRs might be for a vaccine is to read the medicine data sheet and/or consumer medicine information. We will publish this information on our website for any COVID-19 vaccine that is approved for use in New Zealand.

Search for a data sheet or consumer medicine information.

Discuss possible ADRs, and what to do about them, with your healthcare professional.

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Reporting adverse drug reactions

Anyone living in New Zealand who thinks they may have experienced an ADR can report this to the Centre for Adverse Reactions Monitoring (CARM). You do not need to be a healthcare professional to report an ADR.

Reports sent to CARM may describe:

  • real adverse drug reactions to the vaccine
  • anxiety events or nervousness about needles or the process of vaccination
  • coincidental events that would have occurred anyway.

Reporting is easiest online

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ADR eLearning module for health care professionals

This eLearning module for health care professionals explains why ADR reporting is important and how and when to report an ADR.

though aimed at healthcare professionals, anyone can complete this free module.

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More information

See also the following pages on our website.

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