No one has died as a result of Covid vaccines in South Africa, according to the country’s medicines regulator, the South African Health Products Regulatory Authority (Sahpra), which monitors side effects.

Fifty-three deaths of people who had been vaccinated against Covid were reported to Sahpra between 17 May and 31 July —  0.0007% of the 7,059,283 doses administered in that period. (This data excludes side effects or deaths reported for the Sisonke study, for which the last doses were administered on 16 May).

The 53 deaths were reported via Sahpra’s Med Safety app, which it launched in April, or vaccination sites, which reported the incidents to the health department which then reported them to Sahpra.

The regulators’ investigators found no link between the deaths and Covid vaccinations.

Here’s what they found

Six of the people died as a result of infection with SARS-CoV-2, the virus which causes Covid-19. The infections were not as a result of vaccinations as no Covid jabs contain active viruses (an active virus can replicate in people’s bodies and cause illness).

It is still possible to be infected with SARS-CoV-2 even after you’ve been vaccinated — although the jabs do reduce your risk of developing severe disease. This is because no Covid vaccine can guarantee 100% protection.

For five of the reported deaths, investigators could not come to any conclusion about the cause of death because there was not enough information for them to work from.

That’s because the team tracking side effects for Covid vaccines needs to have certain details to conduct its investigation. For instance, the vaccinee’s personal details (name, identity number, and so on) and the results from lab tests that were conducted, Hannelie Meyer explained in a press briefing last week. Meyer chairs an independent advisory team called the National Immunisation Safety Expert Committee (Nisec), which is in charge of monitoring adverse events of vaccines administered in South Africa. 

The remaining cases were all coincidental; in other words, people didn’t die as a result of vaccination, but rather as a result of an existing illness they had before taking the vaccine, for instance.

How do you know if a death is coincidental?

Sahpra is notified of a death or other serious side effects such as a severe allergic reaction after vaccination via the Med Safety app or healthcare facilities. When all information necessary for the investigation is captured in the app, the case will be sent to the national health department for investigation. In cases of causality, the case is then also investigated by Nisec. Ideally, once all the data has been received from the health department and provinces team, Nisec should complete an investigation within 48 hours of it being reported by a health facility or via the app.

Most of the reports filed through the Med Safety app are, however, lacking in the required information, according to Florah Matlala, Sahpra’s deputy director of pharmacovigilance. Pharmacovigilance is the process of monitoring a medicine’s side effects and safety after it is registered and in use by the public.

The lack of details causes delays in the assessment process, Matlala says, since provincial health departments then have to follow up on individual cases to track down the missing information.

When a case reaches Nisec, the committee needs the following information to investigate the case or make a decision on whether the reported side effects or death warrant investigation:

• A full case investigation report, including investigation and reporting forms; and
• A specific diagnosis (say, of the rare blood clot disorder linked to J&J vaccines) that is backed by supporting evidence such as laboratory results or post-mortem reports.

What information does Sahpra need?

This is what they’re looking for:

• An adverse event (in other words a severe side effect) that required hospitalisation or caused an event that resulted in a longer hospital stay;
• A serious adverse event that caused a life-threatening condition, birth defect or death; and
• Any event that occurs more than what is expected from mild side effects of a vaccine. For instance, headaches are a common mild side effect of immunisation, but a prolonged headache could be a reason to investigate further.

If a case ticks all these boxes, the investigation goes ahead.

Sahpra uses the World Health Organization (WHO) guideline, in the form of a detailed form that asks a series of questions, to determine whether a serious side effect — for example, blood clots — is caused by the vaccine.

Questions include: what side effects are associated with the vaccine, what the quality of the jab was when the person received it (for instance, was the shot past its expiry date or was it substandard?), how long after being vaccinated the side effect appeared and if the person had any other medical conditions or was on any other medication at the time.

Ideally, people should report any side effects within 24 hours of identification.

The following information is needed to fully investigate a case:

• The details of the person who received the vaccine. This includes their full name, ID number, contact details, home address, gender and province;
• As much detail as possible on what adverse event the person experienced, such as when it occurred and what happened;
• Any other medical conditions the person may have;
• Additional medications, including traditional medicines, that the person may have been taking;
• Lab results from any tests documenting potential side effects that the person is experiencing; and
• In the case of a death, a post-mortem report is also required.

Obtaining some of these details can be challenging, especially when reports relate to deaths.

Matlala explains: “In many cases that person is already buried and no post-mortem investigation can be done.”

In such cases the investigation can’t be completed at a district or provincial level.

The four ways an investigation can end

During the investigation, inspectors decide in which of the following categories the reported side effects belong:

• The vaccine caused the side effect, which can happen in four ways:

1. Vaccine product-related reaction: Where the vaccine itself, or one of its ingredients, is causing the symptoms despite the jab being correctly handled and administered.
2. Vaccine quality defect-related: The reaction is caused by an issue with the quality of the vaccine itself, such as if a faulty vial is provided by the manufacturer.
3. Immunisation error-related reaction: This occurs when the vaccine has been mishandled, so either it was not handled correctly (like being stored at an incorrect temperature), the wrong dosage was given to a person, or if it was not injected correctly.
4. Immunisation anxiety-related reaction: If someone’s fear of the vaccine or anxiety around being immunised causes the symptoms.

• It cannot be determined if the vaccine has caused the reaction:

This category applies if the timing of when the person received their jab and experienced the side effect aligns but there isn’t yet enough evidence to conclusively link the two events. One reason for this is that it could be a new side effect that has not yet been noted for the vaccine and requires further investigation.

• The vaccine did not cause the side effect:

If a person experiences a side effect that happens to coincide with receiving their jab, but the vaccine is not actually responsible for this reaction. In these cases, the condition may be caused by that person being exposed to something else during the same time frame as their immunisation.

• The case cannot be classified:

If there is not enough information to accurately determine the cause of the reaction then it is placed into this category.

If the cause of a serious side effect or death is linked to a Covid vaccine, a claim can be made to South Africa’s vaccine injury fund. The fund was created to allow people access to financial compensation without having to go to court, which could potentially draw out the process.

Once Sahpra has concluded its investigation, this report can then be used to file a claim to the fund.

What are the main side effects in SA?

Vaccines are designed to train your immune system in how to fight off harmful invaders, in this case the SARS-CoV-2 virus.

The jabs themselves cannot make you sick or infect you with the virus. Instead, vaccines get your immune system to recognise a harmless version or part of the virus. This triggers your body to produce antibodies to fight off the virus that the vaccine is targeting.

In some cases, people experience vaccine-related side effects as a signal that their body is hard at work building up protection. But if you don’t experience any side effects post-vaccination, that’s perfectly normal too.

Potential side effects range on a scale from very common to very rare.

A very common side effect is something you would see in one out of every 10 people vaccinated. Meanwhile, an extremely rare reaction is when an unintended symptom affects fewer than one in 10,000 people, explains Meyer.

The more common a side effect, the more mild it tends to be.

For example, the most common side effect reported to Sahpra is a headache. Twenty-two percent of the 1,036 received for the Pfizer jab and three in 10 people who reported side effects for the Johnson & Johnson jab are for headaches.

Other common side effects reported for the jabs are dizziness, some pain, fever and nausea.

Out of the just over seven million (the number of doses administered in the period that Sahpra’s adverse events report covers) Covid vaccine doses doled out in South Africa, Sahpra has received 1,473 reports of adverse events, or side effects. This means that only 0.02% of people who have got their jab reported experiencing a reaction afterwards.

Side effects are, however, underreported around the world, says Tohlang Sehloho, Sahpra’s senior manager for clinical evaluation.

Of the reports for mild effects that Sahpra received, 1,124 were from people who had received the Pfizer vaccine, while the remaining 349 were among those who got the J&J jab. The higher number reported for Pfizer is because more people have received those doses in our national roll-out for the period which Sahpra’s report covers.

About a quarter of the reports came from Gauteng, with the next highest number coming from KwaZulu-Natal at 16%. Northern Cape has reported the fewest number of side effects, at only 16 — the Northern Cape is also the province that has administered the fewest vaccine doses.

How does Sahpra track side effects?

Sahpra is in charge of overseeing all medications and medical interventions in South Africa. Part of this means keeping an eye out for potential side effects that may arise over time.

In the case of Covid vaccines, jabs are being granted for conditional (for example, J&J) or emergency use approval (for example, Pfizer). These types of approval are given to the jabs in order to make doses available to the country as quickly as possible while still ensuring their safety.

Regulators assess the available information for these jabs to determine if they work at protecting people against disease (in this case Covid-19) and are safe to use.

Once a jab meets all the criteria, it can then be used on a much wider scale as part of the national roll-out. So far, Sahpra has granted approval to Covid vaccines from the following companies: Pfizer-BioNTech, Johnson & Johnson, AstraZeneca and Sinovac. Of these, Pfizer-BioNTech and Johnson & Johnson are used in South Africa.

The way in which people react to the vaccines is continuously monitored by both Sahpra and vaccine manufacturers.

How Sahpra monitors side effects

South Africa’s national roll-out uses a “passive” surveillance system to track Covid-19 vaccine side effects. That means the data collected depends on vaccinated people to report their side effects to Sahpra.

Active surveillance would be impractical, Linda-Gail Bekker, one of the co-lead investigators of South Africa’s Sisonke study, which looked at the use of Johnson & Johnson’s vaccine among health workers, told Bhekisisa in May. That is because active surveillance would require Sahpra to follow up with each vaccinated person individually on a regular basis to find those that have a severe reaction to the vaccine.

For South Africa’s passive surveillance system, people who have received a Covid jab can report their personal experiences and side effects through the Med Safety app (which can be downloaded onto your phone), via the Covid-19 hotline on 0800 029 999 or in person at their nearest clinic.

By the end of July, Sahpra had registered 4,683 users on the Med Safety app with a total of 770 reports filed that month.

Matlala says awareness and uptake of the app are still low.

You can also go to your vaccination site to report your side effects, Health Minister Joe Phaahla said in a media briefing last week.

How manufacturers monitor side effects 

The scale at which Covid jabs are being rolled out means that millions of people around the world are receiving shots in their arms daily. Severe side effects are uncommon, and even large studies or trials will not detect them, because studies test the vaccines on too few people. When entire populations of people are being vaccinated, however, it’s more likely that such side effects will be picked up, because the jabs will be used by millions of people.

As a result, companies that have received approval for their jabs must continue to provide safety updates to Sahpra as new information becomes available. The regulatory body then assesses this data to see if the jab’s side-effects must be updated and inform people of any additional risks that may arise. DM/MC

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.