Published: 1 November 2021

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#MedSafetyWeek 2021 Press Release

1 November 2021

Help make vaccines better for everyone by reporting suspected side effects

Medsafe is today launching #MedSafetyWeek to promote the importance of reporting suspected side effects to the Centre for Adverse Reactions Monitoring (CARM). Taking place from 1 – 7 November 2021, the sixth annual #MedSafetyWeek will focus on vaccines.

“This campaign comes at a crucial time when millions of people are being vaccinated against COVID-19 but is also applicable to all vaccines,” says Medsafe’s Group Manager, Chris James.

“Reporting suspected side effects to the Centre for Adverse Reactions Monitoring plays a key role in helping Medsafe monitor the safety of all vaccines. If a safety concern is identified, we can take action and communicate this to New Zealanders.”

Medicines agencies from 64 countries will be encouraging healthcare professionals, national immunisation programme staff, as well as patients, their carers and whānau, to report suspected side effects with vaccines including COVID-19 vaccines.

Vaccines are the best way to protect individuals against infectious diseases and have already saved millions of lives. Like all medicines, side effects can happen. Most are mild and short-lived. Reporting suspected side effects helps us to monitor vaccine safety.

Anyone who experiences a suspected side effect following vaccination is encouraged to report it to CARM. You don’t have to be a health professional to submit a report and you don’t need to be certain that the reaction was caused by the vaccine. This means that reactions that are reported aren’t necessarily linked to vaccination and can be coincidental.

These reports are monitored by CARM, Medsafe and the Ministry of Health to identify any patterns. The reports are evaluated alongside information from the scientific literature and international medicine regulators to see if there is any link to vaccination.

Medsafe encourages everyone to report suspected side effects from medicines, including vaccines.

Background
  1. National medicines regulatory authorities from 64 countries across the globe and their stakeholders will be raising awareness of reporting, led by Uppsala Monitoring Centre (UMC), the World Health Organisation (WHO) Collaborating Centre for International Drug Monitoring. The campaign is supported by members of the Heads of Medicines Agencies (HMA) and the International Coalition of Medicines Regulatory Authorities (ICMRA). The #MedSafetyWeek 2021 project team consists of representatives from the following organisations working collaboratively: Medicines and Healthcare products Regulatory Agency (UK) as co-lead, Egypt Chapter of the International Society of Pharmacovigilance (ISoP Egypt), the Health Products Regulatory Authority (Ireland), and the Food and Drugs Authority (Ghana).
  2. Medsafe is responsible for protecting and improving the health of millions of people every day through the effective regulation of all vaccines and medicines in New Zealand by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
  3. Anyone may report a suspected reaction to the Centre for Adverse Reactions Monitoring (CARM). The Ministry of Health (through Medsafe) contracts the collection of this information by CARM, which is based at the University of Otago in Dunedin. Report on a COVID-19 vaccine: https://report.vaccine.covid19.govt.nz. For all other vaccines: https://nzphvc.otago.ac.nz/reporting/
  4. Patients are advised to contact a healthcare professional if they are worried about their health.
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