The South African Health Products Regulatory Authority (Sahpra) on August 20 demonstrated a micro-website, detailing information about the safety of the two Covid-19 vaccines used in South Africa, as well as the reported adverse events following immunisation (AEFI), to the media.

The microsite has information about the number of people vaccinated, broken down by age, gender and province, as well as the reported cases of AEFI.

The aim of the website is to provide the information the regulator has to the public to inform them about vaccine safety and risks.

"People are hesitant about certain health products, such as the vaccines, when they do not have sufficient details and do not know enough.

"As Sahpra, we communicate and educate as much as possible on various platforms and a broad range of stakeholders to try to ensure the public is getting correct facts, which will help to overcome vaccine hesitancy," said Sahpra CEO Dr Boitumelo Semete.

Sahpra has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines. Suspected AEFIs to Covid-19 vaccines are reported by health professionals and the public to Sahpra and the National Department of Health (NDoH).

Since the official national roll-out of Covid-19 vaccines on May 17, Sahpra had received 1 473 reports of AEFIs by July 31, of which most were mild, non-serious and already listed in the internationally approved product information.

These AEFI 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.

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.

Certain adverse events have been designated by 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.

"These also serve as signals for health products regulators to investigate further. Even indeterminable cases where AEFI cases cannot be classified as causally linked with a vaccine based on available evidence are monitored because they could be potential signals.

"If more indeterminable cases are observed, it may indicate a need for specific studies to investigate those events," explained Sefako Makgatho Health Sciences University Public Health Pharmacy and Management Professor Hannelie Meyer.

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 or linked to the vaccination.

Four cases are unclassifiable, as 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 is launching a microsite, in collaboration with the NDoH, 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 Sahpra AEFI microsite has links to the fact sheets and professional information for each of the vaccines used in South Africa, as well as information about how to report AEFIs and information about the proportions of vaccinated people who experienced AEFIs.

"The public and health professionals are encouraged 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 AEFIs can be reported by calling the Covid-19 hotline on 0800 029 999."

The NDoH Expanded Programme on Immunisation is responsible for the Covid-19 vaccination programme and collaborates with Sahpra to oversee vaccine safety monitoring and reporting of AEFIs throughout the country.