DURBAN - The South African Health Products Regulatory Authority (Sahpra), mandated to oversee the safety, efficacy and quality of all medicines registered in South Africa, including vaccines, has launched an adverse events of special interest (AESI) micro-site with the National Department of Health.
In a statement, it said the health department’s Expanded Programme on Immunisation (EPI) is responsible for the Covid-19 vaccination programme, and therefore collaborated with SAHPRA to oversee vaccine safety monitoring and reporting of adverse events following immunisation (AEFIs) throughout the country.
Sahpra CEO Dr Boitumelo Semete said suspected AEFIs to Covid-19 vaccines were reported by health professionals and the public to the medicines regulator and the health department.
“Certain adverse events have been designated by World Health Organization (WHO) as adverse events of special interest (AESI). AESIs need to be carefully monitored, and any potential association with vaccination must be confirmed by further investigation. Since the official national roll-out of Covid-19 vaccines commenced on 17 May 2021, Sahpra had received 1 473 reports of AEFIs by 31 July 2021, of which most were mild, non-serious and already listed in the internationally-approved product information, “ said Semete.
She added that 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.
“Mild and non-serious AEFIs are expected to resolve within a few days after vaccination and without any prolonged or persistent negative outcomes. Examples of these include mild headache, pain and redness at the injection site and mild fever. Reported serious AEFIs, including AESIs, have been found to be extremely rare for the Covid-19 vaccines,” said Semete.
Serious 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
- result in death.
The regulator added that after it receives a report of a serious reaction, an investigation is conducted by a multi-disciplinary team from the district or the province, preferably within 48 hours.
“Once all the information about the case is available, causality assessment is conducted by the National Immunisation Safety Expert Committee (NISEC), an independent ministerial advisory committee. Staff members from Sahpra and the EPI provide secretarial support to the weekly NISEC meetings,” said Semete.
It said once completed, the committee assessment is shared with Sahpra and the health department for further action, if necessary.
The regulator said timeous reporting of the case is equally important to ensure a thorough investigation and urgent action if required.
In the case of a death that occurred after vaccination, the following information must be submitted, to facilitate a comprehensive causality assessment:
- An autopsy or 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.
Sahpra said it could not be possible to accurately determine causality when the information provided is incomplete. To date, investigations for 32 death cases have been completed, and causality assessment 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.
Sahpra encouraged the public and health professionals to report incidents to the health facility delivering the vaccine on the Med Safety App (which can be downloaded from App Stores for Android and iOS phones) or by calling the COVID-19 hotline on 0800 029 999.
Sahpra said the data on the micro-site was two weeks behind and updates would be loaded on a weekly basis.
CLICK HERE to access the SAHPRA Adverse Event Microsite.
THE MERCURY