GARDEN ROUTE | KAROO NEWS - A total of 1 473 reports of adverse events following immunisation (AEFIs) has been received by the SA Health Products Regulatory Authority (Sahpra) since the Covid-19 vaccination rollout started on 17 May this year up until 31 July.

Sahpra says most of these were mild and not serious and already listed in the internationally approved product information. "These reports account for a 0,02% reporting rate of the almost 7,1 million doses of Covid-19 vaccines administered in South Africa by then."

During this period, 53 reports of death (0.0007%) were received among people who received vaccines. Out of these, 21 cases are still under investigation.

After investigation into 32 of these deaths, it was concluded that 28 were not related to the vaccination.

The remaining four cases are "unclassifiable" because there was either no information available about the case or the information was completely inadequate, so assessment of the cause could not be conducted or concluded.

Sahpra says reported serious adverse events, including adverse events of special interest (AESIs), have been found to be extremely rare. "Adverse events of special interest need to be carefully monitored and any potential association with vaccination must be confirmed by further investigation."

Mild adverse events include mild headache, pain and redness at the injection site and mild fever, and are expected to resolve within a few days after vaccination.

Reporting of adverse events

Adverse events can be reported to the health facility delivering the vaccine, on the Med Safety App (which can be downloaded from App Stores for Android and iOS phones), or by calling the Covid-19 hotline on 0800 029 999.

Check updates on Sahpra's new microsite

Sahpra is launching a microsite, in collaboration with the National Department of Health, where all information pertaining to AEFI reports received will be communicated to the public. The data on the microsite is two weeks behind and updates will be loaded on a weekly basis. The site address is available here.

Serious AEFIs are those that require hospitalisation or prolong an existing hospitalisation, may be life threatening, result in a congenital anomaly/birth defect, or result in death.

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