COVID-19 vaccination consent

COVID-19 vaccination consent

10 August, 2021

Considerations for undertaking informed consent for those aged under 60 requesting AstraZeneca vaccine:

  • Only senior and experienced immunisers should be consenting and vaccinating those aged under 60 for AstraZeneca
  • Vaccinators should complete the AstraZeneca supplementary module
  • Vaccinators should be up to date with latest information regarding TTS
  • Vaccinators should be aware of contraindications and precautions in administering AstraZeneca and confirm with each potential vaccinee that they do not have any of these conditions. These are listed on pre-vaccination checklist.
  • Vaccinators should undertake informed consent in keeping with ATAGI guidance and use the Commonwealth consent formfor providers
  • Ensure there is a comprehensive risk-benefit discussion
  • Inform potential vaccinees in this younger age range that they are at increased risk of TTS with increased severity and poorer outcomes
  • Discuss this documentthat weighs up benefits against risk
  • All potential vaccinees and those who decide to receive AstraZeneca must be provided with access to a patient information sheet and have it discussed with them, explicitly highlighting the symptoms of TTS
  • All persons who receive AstraZeneca must leave with a link to (via QR code) or physical handout of the patient information fact sheet of what to expect after being given AZ. Ensure they have finished reading it by the time they have completed their observed 15min waiting period post vaccination and understand the potentially serious symptoms to look out for (e.g. persistent headache after 48 hours) and what actions to take should they experience them.
  • Provide a translated patient information sheet if preferred and ensure interpreters are utilised as necessary

Additional considerations for undertaking informed consent in children and young people

  • Anxiety or pain related reactions to any vaccines are higher for children and adolescents, including the risk of syncopal seizures. While most cases of fainting and syncopal seizures are not serious, there is a risk of injury and normal observation post vaccination should occur.
  • Victorian data show an increased rate of allergic adverse events following immunisation as age decreases, however no interstate or international data are available on allergic reaction by age.
  • Broadly, younger age groups may be more likely to report having mild, common and expected adverse events.