DURBAN - THE SA Health Products Regulatory Authority (Sahpra) has said investigations into the deaths of 32 people after receiving Covid-19 vaccines found that 28 of them were not related to or linked to vaccination.
The four other cases were unclassifiable because there was either no information available about the cases, or the information was inadequate.
Sahpra has a mandate to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines. It said suspected adverse events following immunisation (AEFIs) were reported to it and the national Department of Health by health professionals and the public.
Sahpra said that certain adverse events had been designated by the World Health Organization as adverse events of special interest (AESI).
Since the official national roll-out of Covid-19 vaccines commenced on May 17 this year, Sahpra said it had received 1 473 reports of AEFIs by July 31, of which most were mild, non-serious and already listed in the internationally approved product information. “These reports account for a 0.02% reporting rate of the almost 7.1 million doses of Covid-19 vaccines administered in South Africa by then.”
It said mild and non-serious AEFIs, including mild headache, pain and redness at the injection site, and mild fever, were expected to resolve within a few days after vaccination and without any persistent negative outcomes.
Explaining the process followed when a report of a serious AEFI/AESI was received, Sahpra said an investigation was conducted by a multi-disciplinary team, preferably within 48 hours.
“Once all the information about the case is available, a causality assessment is conducted by the National Immunisation Safety Expert Committee; an independent ministerial advisory committee. The purpose of a causality assessment is to determine the likelihood that the event might have been caused by the medicine/ vaccine received, or if it occurred by chance.
“A coincidental adverse event is one that occurred after, or at the same time as, exposure to the medicine/ vaccine, but which is not caused by that exposure.”
Information needed in the case of a death that occurred after vaccination included a post-mortem examination; full clinical history, including any comorbidities and allergies; and listing of all medicines taken prior to, and at the time of, the adverse event.
“To date, investigations for 32 death cases have been completed and causality assessments concluded, of which 28 were coincidental to vaccination. This means that these deaths were not related/linked to the vaccination. Four cases are unfortunately unclassifiable because there was either no information available about the case, or the information was completely inadequate.”
The public and health professionals can report AEFIs to the health facility delivering the vaccine, or on the Med Safety App (which can be downloaded from app stores for Android and iOS phones), or by calling the Covid-19 hotline at 0800 029 999.
THE MERCURY