Interpretation: Although rare, a statistically significant association between BNT162b2 vaccination and myo/pericarditis and AKI was observed. While the association between BNT162b2 and myo/pericarditis has been confirmed internationally, further research is required to understand the association of AKI. BNT162b2 was not found to be associated with most of the AESIs investigated, providing reassurances around the safety of the vaccine.
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The safety of BNT162b2 is monitored predominantly through a spontaneous reporting (passive) system by Medsafe, in collaboration with the Centre for Adverse Reactions Monitoring (CARM), with support from the COVID-19 Vaccine and Immunisation Programme within the Ministry of Health New Zealand. This system relies on reports being voluntarily submitted by health care professionals and the public. Although it is effective at signal detection, it can be subject to several limitations, namely underreporting, incomplete reports, limited information on cases and reporting biases.
Remember that in Medsafe's own words "it is estimated that only 5% of all reactions are reported so there is still room for improvement."
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These findings provide further reassurance on the safety profile of the vaccine, particularly from a New Zealand specific context. Importantly, studies have found that the risk of any of these AESI following SARS-CoV-2 infection is substantially greater than after COVID-19 mRNA vaccination.
There it is.
Also, they only looked at 21 days post vaccination when there have been multiple signals there can be problem 60 days out.