About this item
- Issue date:
- 3 July 2023
- Corporate Author:
- COVID-19 Vaccine Independent Safety Monitoring Board
- Document date:
- 3 July 2023
- Copyright status:
Copyright Held by Non-Crown Party
Established in February 2021, the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) provided advice to the Centre for Adverse Reactions Monitoring (CARM), Medsafe and the Ministry of Health on the safety of the COVID-19 vaccine(s). It was important for the CV-ISMB to be independent from the Ministry, Te Whatu Ora and other advisory groups.
Expert advice provided by the CV-ISMB has been invaluable. Medsafe and the National Immunisation Programme used advice from the CV-ISMB to support regulatory action and safety communications about COVID-19 vaccines.
This final report, a requirement of the CV-ISMB’s Terms of Reference, includes data to 28 November 2022. The CV-ISMB considered 24 safety signals for the Pfizer/BioNTech COVID-19 vaccine, which led to 40 recommendations to either Medsafe or the National Immunisation Programme. Throughout 2021 and 2022 the benefits of vaccination greatly outweighed the risk of both COVID-19 infection and vaccine adverse reactions.
The CV-ISMB presented this final report in 2023 and the CV-ISMB concluded on 30 June 2023. Responsibilities held by the CV-ISMB have been handed over to Medsafe.