The South African Health Products Regulatory Authority (Sahpra) is launching a microsite with the Department of Health (DoH), where all reports of adverse events following immunisation (AEFI) will be communicated to the public.

Data on the new site will be two weeks behind and updates will be loaded weekly.

Since the official national roll-out of Covid-19 vaccines on May 17, Sahpra had received 1 473 reports of AEFIs by July 31.

Sahpra says most of the AEFIs were mild, non-serious and already listed in the internationally-approved product information.

These included mild headache, pain and redness at the injection site and mild fever.

They account for a 0.02% reporting rate of the almost 7.1-million doses of Covid-19 vaccines administered in South Africa at that time.

“To date, investigations for 32 death cases have been completed and causality assessment concluded, of which 28 were coincidental to vaccination. This means that these deaths were not related/linked to the vaccination. Four cases are unfortunately unclassifiable because there was either no information available about the case or the information was completely inadequate. Hence, causality assessment could not be conducted or concluded,” Sahpra explained.

The authority is urging the public and healthcare professionals to report AEFIs.

It says serious AEFIs are defined as those that require hospitalisation or prolong an existing hospitalisation; may be life threatening; result in a congenital anomaly/birth defect; or result in death.

The organisation says reported serious AEFIs have been found to be extremely rare for the Covid-19 vaccines.

However, reports of AEFIs can be made 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.