With just more than 12 million doses of COVID-19 vaccines already administered countrywide, the South African Health Products Regulatory Authority (SAHPRA) said during a media briefing this week that none of the deaths that occurred after vaccination were related to any of the vaccines.
According to a report in The Citizen, SAHPRA had received 86 serious adverse events reports relating to the deaths of people who died after receiving the vaccine. The reports were received between 17 May 2021 and 31 August 2021.
Of the 86 deaths, 46 are under investigation while 40 were investigated and causality assessments have already been conducted. It was found that 34 deaths were coincidental to the vaccine while 13 people had COVID-19 when they died and one case was a breakthrough infection.
Six cases were unclassifiable due to inadequate information. It was also revealed during the briefing that the Department of Health is working on a ‘no-fault compensation scheme’, which is a fund that will be established to pay those who suffer damages as a consequence of the vaccine being administered. National vaccine co-ordinating committee representative Marione Schönfeldt touched on the benefits of the scheme, which include getting compensation without having to resort to court processes.
Schönfeldt said claimants would not have the burden of establishing negligence or wrongfulness on the part of the department or the vaccine manufacturer. However, a causal link would have to be established, therefore proof that the vaccine caused the adverse event following immunisation (AEFI). She indicated that there was enough funding available to pay out successful claims.
Moneyweb reports that 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 side effects.
People experiencing adverse drug reactions or adverse events post- immunisation should report these on the Med Safety App, which is aimed at tackling the underreporting of vaccine side effects and increase awareness for the public and medical professionals.
“The Med Safety App 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.
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