No compensation for vaccinated people if they experience serious side effects

Deputy Health Minister Dr Sibongiseni Dhlomo says there is no plan to compensate people who experience serious adverse events after receiving the Covid-19 vaccine.

“[Someone] asked whether there is any plan to compensate people who have got serious adverse events. The answer is no. Until and unless there has been a report showing that it was actually due to this and that vaccine…” the deputy minister said.

Dhlomo was briefing MPs during Parliament’s portfolio committee on health virtual meeting on Thursday evening.

The South African Health Products Regulatory Authority (Sahpra) continues to monitor adverse events, which were reported by people who have been inoculated with the double-dose Pfizer-BioNTech vaccines and the single-dose Johnson & Johnson (J&J) shot.

Saphra revealed in July that it was investigating the cause of deaths of 28 people who died after receiving the vaccine.

However, the regulator indicated that there was no evidence which proved that the deaths were linked to the vaccine.

Vaccine safety in SA: Inoculation shows ‘significant reduction in deaths’

What is an adverse event?

An adverse event following immunisation (AEFI) is any untoward medical event which follows immunisation and does not necessarily have a causal relationship with the usage of the vaccine.

In addition, an adverse event of special interest (AESI) is a pre-specified medically significant event which has the potential to be “causally associated with a vaccine product”.

Adverse events are split into two different categories, which include:

• Non-serious: Chills, fevers, headache and nausea
• Serious: Thrombosis, hospitalisation and death.

According to the National Institute for Communicable Diseases (NICD), adverse events usually occur within 28 days following vaccination, however, there is no time limit to reporting an event.

Sahpra’s guidelines on health products vigilance state that anyone can report an adverse event.

How to report adverse events

Adverse events following immunisation can be reported at any health facility, using the Covid-19 hotline – 0800-029-999 – or via the Med Safety App.

When an AEFI or AESI is reported, the National Immunisation Safety Expert Committee (NISEC) reviews data about the case and determines the likelihood of a causal association between the event and the vaccine received.

The case investigation is carried out by trained healthcare workers and the multi-disciplinary team is made up of epidemiologists, clinical psychologists, surgeons, nurses and clinicians.

Click here to find instructions on how to use the MedSafety App.

Vaccine stats

Over 10 million people have been vaccinated with at least one dose as of 9 September, which makes up 26.4% of the adult population.

Of this number, just over seven million have been fully vaccinated, which is 17.6% of the adult population. 

Women are still leading the pack in terms of receiving the most vaccine does, with them making up 57.7% of the total. Males are at 42.3%, a statistic Health Minister Phaahla said needed to improve. 

Around 225,000 vaccine doses are being administered daily, including second doses which Phaahla said needed to be pushed up to 300,000. 

However, he said once the country receives more Johnson & Johnson doses, this should increase the numbers of fully vaccinated people. 

Additional reporting by Nica Richards and Cheryl Kahla