Phase 2 of South Africa’s Covid-19 vaccine roll-out, aiming to vaccinate citizens over the age of 60, is under way and people are being asked to report any mild, moderate or severe adverse events experienced after receiving their jabs.

Reporting adverse events is a critical part of monitoring vaccine safety once a vaccine has been rolled out to the broader population. The timeous reporting — specifically of serious adverse events — means a specialist review or causality committee can either rule out or confirm whether there is a link to the vaccine.

Spotlight has been alerted to calls by an “independent” online organisation for people to report, on the organisation’s site, adverse events they may experience. To avoid confusion, we spoke to the South African Health Products Regulatory Authority (SAHPRA) and the national health department to map out the official and credible channels for reporting and to explain how to report mild, moderate or severe adverse events following immunisation.

Florah Matlala of SAHPRA’s pharmacovigilance unit and Hannelie Meyer, professor at the School of Pharmacy at the University of the Western Cape and head of the South African Vaccination and Immunisation Centre at Sefako Makgatho Health Sciences University in Gauteng, say that all adverse events should be reported, whether they are mild, moderate or severe. This means anything of concern must be reported. 

Why should the public report an adverse event following immunisation (AEFI)?

When a new vaccine or medicine is registered for use, such as the Covid-19 vaccines, data on safety is limited to what has been identified in clinical trials. The main benefit of reporting an AEFI, whether minor or severe, is that everyone contributes to the safety surveillance of the vaccines, and not just those who participate in trials.

Data on rare adverse events, or adverse events with a slow onset, can be detected only when vaccines are used by a large number of people, and when these events are actually being reported. 

Reporting assists the health department and SAHPRA with the collection of data, but more importantly, this data is necessary to ensure the safety of the public. 

When a previously unknown rare event is reported, action can be taken to prevent others from also experiencing this rare event in future. By reporting adverse events, you are making an important contribution to ensuring the safety of vaccines and can help prevent further harm to yourself, your family and others who may experience similar reactions.

South Africa is one of four pilot countries (South Africa, Nigeria, Ghana, Ethiopia) of the African Union’s Smart Safety Surveillance (AU-3S) programme, which is a 10-year programme aimed at strengthening pharmacovigilance (strict monitoring) in Africa.

All AEFI reports submitted electronically through SAHPRA’s Med Safety App by the four countries will be pooled for signal detection. A committee of experts from the four countries will review and discuss possible signals, followed by communication with the relevant countries as appropriate.

When should people report an AEFI?

Ideally, it should be reported immediately.

All severe and serious AEFIs are investigated. First, an investigation is done by a multidisciplinary team at district or provincial level within 48 hours of the reporting. A causality assessment is then conducted by the National Immunisation Safety Expert Committee (NISEC) to determine whether the event may have been caused by the vaccine or whether it was a coincidental event. The NISEC also does causality assessments for clusters, rare events or any other events of concern.

Depending on the outcome of the causality assessment, feedback is given to the programme and other ministerial-appointed advisory committees. The aim is to ensure vaccine safety, mitigate any possible risks and maintain the integrity of the vaccination programme.

How can the public report an AEFI?

The Med Safety App allows people to report an AEFI from the comfort of their home, directly to SAHPRA and to the national health department. 

People who do not have access to smartphones or who might not be able to use the app can still report an AEFI directly to their healthcare professionals. In the case of connectivity challenges, the app can also be used offline. The report can be saved and then submitted when connectivity is available. A dedicated email address ([email protected]) and helpline at SAHPRA (012-501 0311 on weekdays during office hours) are available for anyone experiencing challenges using the app for reporting an AEFI.

The Med Safety App is available for use by both healthcare professionals and the public. It can be downloaded to a smartphone from the Google Play Store or Apple App Store. Using it is simple:

• Choose your region;
• Acknowledge the Privacy Statement;
• Create a profile as a member of the public or a healthcare worker;
• You are ready to report AEFIs/adverse drug reactions;
• Make sure you choose the correct reporting form as there are two reporting forms, one for AEFIs (vaccines) and the other for ADR (medicines).

How does the department of health call centre work?

The call centre can be reached free on the Covid-19 public hotline 0800 029 999. Selecting option 3 will divert your call to the safety desk where call centre staff can assist healthcare professionals or the public with questions post-vaccination.

Call centre staff at the safety desk have also been trained on the use of the Med Safety App and can respond to questions about using the app, assist callers to submit a report while they are on the call, and submit a report using the app on behalf of callers who cannot do so themselves. 

Is the NICD case reporting form for public use?

All the paper-based forms are available on the National Institute of Communicable Diseases (NICD) and SAHPRA websites. These are specifically for use by healthcare professionals.

Although electronic reporting through the Med Safety App is now the preferred method of reporting, should a healthcare professional not have access to the app or experience any challenges using the app, the paper-based reporting system can still be used. 

All paper-based reports must be emailed to a central email address ([email protected]) to prevent any delays in communication. These reports will be entered manually into the system at provincial level. 

What happens if a person has anaphylaxis, a rare but serious allergic reaction? 

If a person experiences a serious adverse event, such as anaphylaxis, they need to go to a health facility or see their doctor immediately to get the treatment they need.

Anaphylaxis, in most cases, occurs in the first 15 minutes after vaccination. This is why everyone is required to remain at the vaccination site for a 15-minute observation period post-vaccination. People with a history of allergies are required to stay at the site for observation for 30 minutes as a precautionary measure. 

Anaphylaxis is, however, very rare.

The majority of adverse reactions are mild to moderate in severity and resolved within one to two days of vaccination.

If a person experiences a mild AEFI, for example fever, headache or muscle aches, it can be managed symptomatically through the administering of an analgesic such as paracetamol. DM/MC

Adele Baleta is an independent science writer and a member of the Vaccine Hesitancy Working Group for the National Advisory Group on Immunisation.

This article was produced by Spotlight — health journalism in the public interest.