- Sahpra has created a microsite for reporting post-Covid-19 adverse vaccine events.
- The site was created for the purpose of transparency.
- The organisation is working with the Department of Health to establish and investigate cases.
The South African Health Products Regulatory Authority (Sahpra) wants to promote transparency with its new adverse events following immunisation (AEFIs) microsite. This platform has been created for the public to report adverse effects after receiving Covid-19 vaccines.
"There is a need for transparency from scientists and regulators from health departments, and we need to be sharing information so that we have the public's confidence that we're honest in the sharing of that information. That would be the first real concern and, and having a website like this, having a reporting mechanism is one of the steps we can take to do it," says Sahpra chairperson Prof Helen Rees.
Saphra CEO Dr Boitumelo Semete-Makokotlela said on Friday that the organisation is also taking lessons from other countries with similar sites: "What you will note is that also if you visit other regulators websites, who have seen something similar. And so we have ensured that we learn from others and they learn from us, and we share in terms of some of the results that we've seen because some of them are not unique to South Africa, they've been observed in other countries," she says,
Reporting adverse events
The regulatory body defines serious AEFIs as post-vaccine reactions requiring hospitalisation or prolonging an existing hospitalisation, which may be life-threatening, result in a congenital anomaly or congenital disability, and result in death.
There are three different ways to report AEFIs:
- Reporting to the health facility delivering the vaccine
- Using the Med Safety App, downloaded from App Stores for Android and iOS phones
- Calling the Covid-19 hotline on 0800 029 999
Sahpra is working with the National Immunisation Safety Expert Committee (NISEC), an independent ministerial advisory committee.
NISEC will be investigating cases that are reported. According to Prof Hannelie Meyer from the committee, they will run causality assessments to determine AEFIs. This includes whether each case makes it to the inclusion criteria; previous health condition before taking the vaccine; the time-frame from when the vaccine was taken; and clinical information from claimants' health practitioners.
Since the start of the Covid-19 vaccination programme until 31 July 2021, Sahpra has received 1 473 reports of AEFIs.
"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. 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," Sahpra says in a statement.
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