From February 2021 to November 2021, the COVID-19 Vaccine Independent Safety Monitoring Board (the Board) met to review and discuss safety data for the Pfizer COVID-19 vaccine.   

The Board has now published an interim report about its findings. The key findings have previously been publicly reported.

During this period more than 7 million doses were administered. Almost 90% of the eligible population (12 years and older) had received two doses of the vaccine. 

Given the large proportion of the population being vaccinated in a relatively short period of time, it is understandable that there were a number of adverse events reported following vaccination. A number of events can also be expected to occur coincidentally in the period following vaccination. 

Of the reported adverse events, less than 5% are classified as serious. Of the 39,973 adverse events following immunisation reported during this time period, 1,593 serious cases were reported to the Centre for Adverse Reactions Monitoring (CARM). 

A serious adverse event following immunisaton (AEFI) is one that requires hospitalisation or prolongs existing hospitalisation, causes persistent or significant disability or incapacity, is life threatening, causes a congenital anomaly/birth defect, results in death or is a medically important event or reaction. 

The Board considered 18 safety signals (information on a new or known adverse event that may be caused by the vaccine and requires further investigation) which led to 28 recommendations to either Medsafe or the Ministry of Health.

Out of the 18 safety signals for the Pfizer COVID-19 vaccine, only one has been confirmed in New Zealand, with myocarditis and pericarditis identified as very rare adverse reactions to the Pfizer COVID-19 vaccine. 

The Board has been reassured by both the international and New Zealand data presented, that the Pfizer COVID-19 vaccine is a very safe vaccine. 

The full report is available on the Ministry of Health website. 

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