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The South African Health Products Regulatory Authority unpacks monitoring vaccine safety and adverse events following immunisation

There have been notable and extensive discussions about COVID-19 over the past two years… “Be safe, mask up, and sanitise” that has become a mantra for people across South Africa as well as globally. But do we really understand how vaccines are being monitored to assess probable side-effects being experienced by pockets of our population?

The South African Health Products Regulatory Authority (SAHPRA) unpacks and provides some useful information around COVID-19 in South Africa from the perspective of vaccines being administered to the population: how they are monitoring the safety of these vaccines, and what do these safety statistics mean to South Africans.

SAHPRA has been propelled into the deep end when it comes to dealing with a plethora of issues as evidenced in the various news articles (print, broadcast and online) on, for instance, challenging the use of Ivermectin for human use to the approval of vaccines for the COVID-19 virus. In essence, SAHPRA is an organisation that regulates (monitoring, evaluating, investigating, inspecting, and registering) all health products for both human and animal use in the country. This includes clinical trials, complementary medicines, medical devices, and in vitro diagnostics (IVDs). Their task is to protect the health and well-being of South Africans.

SAHPRA’s response to COVID-19

Like the South African Police Services (including the Directorate for Priority Crime Investigations (“The Hawks”)) which has a specific area that focuses on areas of organised crime, economic crime, corruption, etc. In the same way, SAHPRA, through a specialised Vigilance Unit, and as the name suggests, collects, and analyses information (data) from clinical trials and safety surveillance to monitor the safety of vaccines and medicines used against COVID-19. The unit ensures that risks associated with vaccines and medicines used against COVID-19 are identified, managed properly, and communicated accordingly.

Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioural intervention. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Post-marketing surveillance also referred to as “safety surveillance” is the practice of monitoring the safety of a health product after it has been approved for use in the general population. It is an important part of the science of pharmacovigilance. Post-marketing surveillance is used to confirm or disprove the safety of a medicine after it is used in the general population by large numbers of people who have a wide variety of medical conditions by using approaches such as spontaneous Adverse Drug Reactions (ADR) reporting procedures, pregnancy registries, etc.

Authorising COVID-19 vaccines

To curb the spread of the COVID-19 virus in South Africa, SAHPRA has reduced the time taken to authorise COVID-19 vaccines to less than 90 working days. Yes, this may come across as questionable; however, SAHPRA is continuing to adhere to strict guidelines without compromising the quality, safety, and efficacy of vaccines to ensure the prompt availability of these vaccines.

Usually, approving a new medicine takes 20 months, on average. SAHPRA is currently evaluating several applications for emergency use (Section 21) and/or registration of COVID-19 vaccines. Whenever a vaccine is approved, SAHPRA always informs the public, so they are aware of different options available. However, it is the National Department of Health (NDoH) that is the only authority that can roll-out and administer vaccinations.

COVID-19 vaccines were first introduced in South Africa through the Sisonke study, which aimed to further monitor the effectiveness and safety of the COVID-19 Janssen (J&J) amongst healthcare professionals. The Sisonke study commenced on 17 February 2021 and was completed by 17 May 2021, after vaccinating 495 829 vaccine recipients including, 479 768 healthcare professionals.

South Africa began its national vaccine roll-out in May of 2021 with both the Comirnaty® (Pfizer-BioNTech) vaccine and Janssen COVID-19 vaccine.

To date, SAHPRA has registered the:

  • Comirnaty® (Pfizer-BioNTech) vaccine
  • Janssen COVID-19 vaccine
  • COVID-19 vaccine MC Pharma
  • CoronaVac® vaccine
  • COVID-19 vaccine LHC
  • Covovax vaccine

Molnupiravir generic products, Molcovir by Bliss Pharmaceuticals (Pty) Ltd and Molnupiravir 200 DRL by Dr Reddy’s Laboratories (Pty) Ltd, were granted S21 authorisations (for emergency use) on 31 May and 06 June 2022, respectively. SAHPRA has also authorised, with conditions, the importation of Molnupiravir 200mg capsules, Lagevrio®, in terms of Section 21 of the Medicines and Related Substances Act, 1965, as amended.

Monitoring the impact of vaccines

Countries across the globe have had to monitor the impact of COVID-19 vaccines due to their unprecedented nature and record timelines involved in their development. The World Health Organisation (WHO) has also developed a detailed surveillance manual to guide healthcare professionals.

One way that SAHPRA is monitoring the effects of the COVID-19 vaccine is through the Med Safety App. This app is designed for both public and healthcare professionals to report suspected Adverse Drug Reactions (ADRs) or Adverse Events Following Immunisation (AEFIs).

Adverse drug reaction (ADR) is a noxious and unintended response to a medicine, which can also result from overdose, misuse, or abuse of a medicine. The reaction may be a known side effect of the medicine, or it may be new and previously unrecognised.

Adverse event following immunisation (AEFI) is defined as any untoward medical occurrence which follows immunisation; does not necessarily have a causal relationship with the usage of the vaccine; may be any unfavourable symptom which a vaccine recipient complains about; and may be an abnormal laboratory finding, sign or disease found by medical staff.

With all the data being collected through the MedSafety app across many medical issues, including COVID-19, there was a need for SAHPRA to provide access to information on AEFIs reported through a portal: So, when browsing this data, it is important to understand that the reported cases here have not been assessed in terms of causality, meaning that these events (AEFIs) may not necessarily be linked to COVID-19 vaccines. Also, the data on the portal is within a specific timeframe namely, 17 May 2021 to 30 April 2022.

What do the stats say?

According to the data collected during the period 17 May 2021 to 30 April 2022, there was a total of 5 893 AEFIs reported, for both the J&J and Pfizer vaccines, from over 34 million administered doses. This shows a 0.0172% of reported cases, which is minimal. In terms of the most affected age group, which was between 40 – 49 years, there were 331 and 961 AEFIs reported for J&J and Pfizer vaccinations respectively. The more data SAHPRA collects, the better they can understand and monitor the impact of the various vaccinations being rolled out in the country.

  • Total number of AEFI reports received (17 May 2021 to 30 April 2022)
  • Number of AEFI reports distributed by age and vaccine dose (17 May 2021 to 30 April 2022)

Vaccine risks recognised

For those who have chosen to be vaccinated, there have been many medical ailments running through your mind. Here is a quick overview of identified issues of myocarditis and pericarditis, Guillain-Barré Syndrome (GBS), thrombosis with thrombocytopenia syndrome (TTS), and menstrual disorders post immunisation. That was a mouthful but here are some quick snippets.

Myocarditis and Pericarditis

Myocarditis and pericarditis are diseases that cause inflammation of the heart that can occur following infections or immune-related diseases. Symptoms of myocarditis and pericarditis can vary but may include shortness of breath, palpitations, irregular heartbeat, and chest pain. The public are advised to seek medical attention if they experience any of these symptoms following vaccination with COVID-19 vaccines.

SAHPRA has identified one reported case of myocarditis in the SAHPRA safety database; however, has not identified any causal relationship between any COVID-19 vaccine and this adverse event. Investigations are ongoing to determine whether this case is coincidental or related to the vaccine.


There were five cases of GBS reported through the SAHPRA safety database. Most vaccinees who experienced GBS post-vaccination were within the ages of 41 to 46 years, except for one case of a 74-year-old patient. SAHPRA and the NDoH are currently monitoring and investigating these events to determine the causal link.


TTS has been in the headlines for the past few months. Two cases reported from the Sisonke cohort were confirmed to be TTS and have fully recovered. The remaining two cases are still under investigation. SAHPRA, in line with the WHO, as well as the European Medicines Agency (EMA), has determined that the known benefits of COVID-19 Vaccine Janssen for the prevention of COVID-19 greatly outweigh the known and potential risks of receiving the vaccine.

Menstrual disorders

SAHPRA is aware of the menstrual disorder reports received in the vaccine safety database. A total of 90 menstrual disorder events have been received since the national roll out on 17 May 2021. Considering 9.85 million vaccinations carried out in the adult female population as of 07 January 2022, the event reporting rate is 0.91 per 100 000 vaccinations (meaning nine events following one million vaccinations). SAHPRA and the NDoH are currently monitoring and investigating these events to determine the causal link.

Each one of us plays an important role in monitoring COVID-19 vaccine safety by reporting AEFIs experienced after your COVID-19 vaccination. You can simply download the Med Safety app and submit your experience here.

The COVID-19 pandemic is continuing to leave a trail of infections globally with its various waves, even in South Africa. What we must continue to do is to remain vigilant as there is no precise timeline for when this pandemic will end. Protecting ourselves, the lives of our loved ones, our neighbours, our colleagues and fellow citizens must be priorities when remembering to mask up (it is now optional), keep your distance and always sanitise.

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