Serious adverse events after vaccination are rare and account for just 0.02% of the 7.1 million doses doses administered in the country, says the South African Health Products Regulatory Authority.
CORONAVIRUS vaccines are safe for use, the South African Health Products Regulatory Authority (Sahpra) has reassured the public.
The regulatory body says serious adverse events after vaccination are rare.
Since the national roll-out of Covid-19 vaccines commenced on May 17, 2021, the body received 1,473 reports of adverse effects caused by Covid-19 vaccines by July 31, 2021.
Sahpra said the reports accounted for a 0.02% reporting rate of the almost 7.1 million doses of Covid-19 vaccines administered in South Africa by then. Most were mild, non-serious and listed in the internationally-approved product information.
Chief executive Boitumelo Semete said that investigations into 32 death cases had 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. Hence, causality assessment could not be conducted or concluded,” she said.
Serious adverse events following immunisation (AEFIs), are defined as those that:
- Require hospitalisation or prolong an existing hospitalisation.
- May be life threatening
- Result in a congenital anomaly/birth defect or in death.
Semete said following receipt of a report of a serious AEFI, an investigation is conducted within 48 hours.
“Once all the information about the case is available, causality assessment is conducted, a procedure used to determine the true relationship between a medicine/vaccine and the occurrence of an adverse event. The purpose of the assessment is to determine the likelihood that the event might have been caused by the medicine/vaccine received, or occurred by chance.”
