COVID-19 vaccines are being held to the same high safety standards as all vaccines and medications licensed for use in New Zealand. Prior to Comirnaty being approved for use in New Zealand, Medsafe extensively reviewed available safety and efficacy data to ensure it met their strict criteria.
Medsafe continues to evaluate all data in different groups and from real-world experience as well as clinical trials. Independent data monitoring boards evaluate all data from clinical trials and safety surveillance data are being reviewed and published weekly by various regulatory organisations, including Medsafe, and by advisory committees including the Global Advisory Committee on Vaccine Safety at the WHO and the Advisory Committee on Immunisation Practices (ACIP) at the CDC in the US.
How to report an adverse event after vaccination with Comirnaty
If you or a patient experience an adverse event after vaccination that is very severe or unexpected you can report this to the Centre for Adverse Response Monitoring (CARM).
- If this occurs at the vaccination clinic, it is recorded through the COVID Immunisation Register to CARM.
- After leaving the vaccination clinic, the patient or you as the healthcare professional can report it directly to the CARM website. A dedicated form has been created for the COVID-19 vaccine.
- Vaccination errors are also reported to CARM.
An adverse event following immunisation (AEFI) may or may not be caused by the vaccine, but if concerned, report it to CARM so that it can be investigated.
An adverse reaction is associated with the vaccine and can severe (e.g. intense but not harmful, such as a sore arm or transient high fever) or serious (life-threatening or persistent).
When an AEFI is reported to CARM, it is investigated to establish if there is ‘causality’ – i.e., is there evidence or a possibility that the vaccine caused the adverse event or was it coincidental?
Global AEFI safety monitoring
The safety of COVID-19 vaccines are being monitored globally and collaboratively. This enables very rare but serious adverse events to be detected across large enough populations.
As part of its reporting to global networks, Medsafe is monitoring for adverse events of special interest (AESI) which will be compared with expected background rates to indicate potential safety signals of concern. This is a list of adverse events developed specifically for COVID-19 vaccines, based on proven or theoretical potential concerns related to how the vaccine works or to SARS-CoV-2 viral infection, created through the Coalition for Epidemic Preparedness Innovation (CEPI)-funded Safety Platform for Emergency vaccines (SPEAC), detailed here.