The South African Health Products Regulatory Authority (Sahpra) and the Department of Health (DoH) claimed in a webinar on Monday that no one in South Africa has died as a direct result of receiving a Covid-19 vaccine to date.
However, Sahpra says if there are any vaccine-related deaths, then there will be compensation through a special compensation fund.
Investigations into reported Covid-19 related deaths showed that people died either as a result of contracting the virus before vaccination or contracting the virus shortly after inoculation, but none died because of taking an actual vaccine dose.
“So these people that died because of Covid-19, they had already incubated Covid-19 at the time of vaccination or they contracted Covid-19 shortly after being vaccinated, before they could mount an adequate immune response,” National Immunisation Safety Expert Committee chair Professor Hannelie Meyer said during the webinar.
The Sahpra data on vaccine side effects comes after a recent survey by Ask Afrika and the Government Communication and Information System found that 23% of South Africans were hesitant to take the vaccine because they feared vaccine side effects.
‘Adverse event’ reports
Sahpra said it has received 2 770 reports of ‘cumulative adverse events following immunisation’ in the period May 17 to August 31, which represents 0.02% of all the doses administered nationally.
The health products authority said 86 cases related to deaths among people who received Covid-19 vaccines were reported.
Of these, 40 have been fully investigated, with Sahpra finding that 34 of the deaths were a coincidence and six were unclassifiable due to lack of information.
“Among the 40 that [have] been causality assessed, none of these [deaths] were related to any of the Covid-19 vaccines we are using in South Africa,” said Meyer.
“The vast majority of them [people whose deaths were Covid-19-related] had multiple comorbidities. As you’ve seen I think there’s 13 of them that have died of Covid-19 infection and then all the others were coincidental deaths, so they had multiple comorbidities.
“For example, a person would have hypertension, heart disease, some would have TB as well [or] obesity. So they died coincidentally to the vaccination because of their comorbidities.”
According to Sahpra stats, more people between the ages of 60 and 69 (484 cases) reported adverse events after receiving the Pfizer BioNTech vaccine, while the highest number of reported adverse events following immunisation for the Johnson & Johnson vaccine was seen in younger people, aged 40 to 49 (176 cases).
Of the cases reported, the most reported side effects for the Pfizer vaccine were headaches (430 cases), local reaction at the point of injection (355) and pyrexia, or the increase of body temperature (231).
The J&J single-dose vaccine saw headaches as the most reported side effect (193 cases), followed by pyrexia (91) and dizziness (88).
It was also revealed during the webinar that the DoH will establish a ‘No Fault Compensation Scheme’ for adverse events following immunisation.
The scheme is aimed at compensating people who suffered serious vaccine injury as a result of taking the Covid-19 vaccine in South Africa.
“However, a causal link will have to be established and therefore proof would have to be provided that the vaccine caused the adverse event,” said D0H pharmaceutical policy specialist Marione Schonfeldt.
“This causal link will be established by the national immunisation safety expert committee.”
Schonfeldt could not indicate how much money government will dedicate to establishing the fund but said the fund will be available to claimants for the foreseeable future.
“The scheme will be operated by the [DoH] and the funding available will be sufficient to cover people [who] suffer from serious adverse events, and it will be available for the time period until it is determined it is no longer required,” she added.
App for self-reporting
People experiencing adverse drug reactions or adverse events post-immunisation are encouraged to report these on the Med Safety App. The app is meant to combat underreporting of vaccine side effects and increase awareness for the public and medical professionals.
“We thought that through the use of the Med Safety App, together with the rollout of the Covid-19 vaccines, it is an opportunity for us to actually promote pharmacovigilance [monitoring the effects of medical drugs after they have been licensed for use],” said Sahpra pharmacovigilance manager Mafora Matlala.
“It has come to our attention that not so many people actually are aware of the medicines that they use and the effects thereof, so this is an opportunity to actually promote pharmacovigilance,” she added.