After investigations, the South African Health Products Regulatory Authority (Sahpra) has been unable to link any deaths reported to it to the Covid-19 vaccine.

Sahpra has so far investigated 29 cases of death that occurred shortly after people received the Covid-19 vaccine, spokesperson Yuven Gounden said.

He added, "To date, 29 investigations have been completed, of which 26 were coincidental to vaccination. This means that these deaths were not related/linked to the vaccination. Three cases are unfortunately unclassifiable because there was either no information available about the case or the information was completely inadequate; hence causality assessment could not be conducted."

People who get adverse side effects after getting the Covid-19 vaccine are encouraged to report this to the regulator.

Gounden said, once the reports are received, they are investigated, preferably within 48 hours.  

Sahpra has received 2 033 reports of adverse events following immunisation, most of which are not serious.  

Gounden said, once a case is reported and all information is gathered by teams from the health department, the National Immunisation Safety Expert Committee conducts a causality assessment.

This independent ministerial advisory committee meets weekly.

“The purpose of the causality assessment is to determine the likelihood that the event might have been caused by the vaccine received, or whether it occurred by chance, coincidentally following the time of vaccination.”

Gounden said there were currently between 20 and 23 cases under investigation. 

"One should not assume that because the event happened after vaccination, it was caused by the vaccination. Hence, submission of all necessary information about the case is extremely important because causality assessment can only be done if sufficient information is available.

"In the case of a death which occurred after vaccination, an autopsy or post-mortem examination is necessary, the clinical history of the deceased, any comorbidities and allergies, concomitant medicines taken." 

Causes

He said if a person is buried and their death certificate states "natural causes", and no post mortem examination was conducted, it becomes impossible to determine any causality. 

Gounden said, to improve transparency, Saphra and the health department would soon launch a site to communicate all information regarding adverse effect reports received. 

Reporting adverse effects can be done at a health facility or by downloading the Med Safety App, which is available for Android and iOS phones, or phone the Covid-19 hotline on 0800 029 999.