Amid alarming vaccine hesitancy, the South African Health Products Regulatory Authority (SAHPRA) on Saturday revealed that it has received more than 1 400 reports of adverse events following immunisation (AEFIs).
SAHPRA is charged with overseeing the safety, efficacy, and quality of all medicines registered in South Africa, including vaccines.
“Since the official national roll-out of Covid-19 vaccines commenced on 17 May 2021, SAHPRA had received 1 473 reports of AEFIs by 31 July 2021,” said the health products regulatory authority.
Most of the adverse effects from the jabs were mild, non-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,” said SAHPRA.
“Mild and non-serious AEFIs are expected to resolve within a few days after vaccination and without any prolonged or persistent negative outcomes.
“Examples of these include mild headache, pain and redness at the injection site, and mild fever.”
This week South Africa passed the milestone of 10 million people vaccinated against Covid-19. The aim is to vaccinate 40 million adults.
The National Department of Health (NDoH) Expanded Programme on Immunisation is responsible for the Covid-19 vaccination programme, and therefore collaborates with SAHPRA to oversee vaccine safety monitoring and reporting of adverse events following immunisation (AEFIs) throughout the country.
Suspected AEFIs to Covid-19 vaccines are reported by health professionals and the public to SAHPRA and the NDoH.
Certain adverse events have been designated by the World Health Organisation as adverse events of special interest (AESI).
AESIs need to be carefully monitored and any potential association with vaccination must be confirmed by further investigation.
Reported serious adverse effects after a jab, including AESIs, are extremely rare for the Covid-19 vaccines.
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.
To date, investigations for 32 death cases have been completed and causality assessment concluded, of which 28 were coincidental to vaccination, said the health products regulatory authority.
“This means that these deaths were not related/linked to the vaccination,” said SAHPRA.
“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.”
South Africa this week reached the milestone of 10 million people vaccinated. The aim is to give 40 million adults a jab.
SAHPRA encouraged the public and health professionals to report AEFIs 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.
