Medicines regulator says serious vaccine side effects are rare

SA’s medicines regulator has reassured vaccine hesitant people that side effects from the shots are rare.

Immunisation efforts in the country have stalled, with the government saying it will struggle to achieve the 70% inoculation level  it needs to create herd immunity to fully reopen economic activity.

The hesitancy has been fuelled in part by a lack of confidence in the safety of the vaccines.

An investigation by the SA Health Products Regulatory Authority (Sahpra) has concluded that out of 32 deaths reported, 28 were not related to the  vaccine. The other four were inconclusive as there was insufficient data on the cases. 

On Friday, Sahpra said since the national rollout of Covid-19 vaccines started in May, it had received 1,473 reports of adverse events or side effects by the end of July.

The side effects, referred to officially as adverse events after immunisation (AEFIs), are reported by health professionals and the public to Sahpra and the department of health. 

The authority said most of the these cases were “mild, non-serious and already listed in the internationally approved product information”.

The reported cases account for a 0.02% reporting rate of the almost 7.1-million doses of Covid-19 vaccines administered in SA by end-July.

“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,” said Sahpra. 

It said serious AEFIs —  those that require hospitalisation or may be life threatening —  have been found to be extremely rare for Covid-19 vaccines.

gavazam@businesslive.co.za