Sahpra says it’s investigating adverse reactions to COVID vaccines

The authority is also taking a closer look at breakthrough infections in people already vaccinated.

A vaccinator preparing the COVID-19 vaccine. Picture: Abigail Javier/Eyewitness News.

CAPE TOWN - The South African Health Products Regulatory Authority (Sahpra) is investigating adverse reactions to COVID-19 vaccines.

The authority is also taking a closer look at breakthrough infections in people already vaccinated.

The regulatory body has on Wednesday briefed Parliament’s health committee.

Sahpra said one of its mandates was to ensure vaccine applicants had the ability to record and report side effects.

It said the assessment of efficacy against variants of concern was also critical.

Sahpra CEO Tumi Semete-Makokotlela said they were closely monitoring what they termed “adverse events following immunisation” after reports of side effects.

“There are causality studies that are currently ongoing. And what a causality study is to say, we need to determine if the event that we saw is indeed related to the vaccine or related to something else. So, these are the very comprehensive studies that will be conducted, and autopsies will be done”

Semete-Makokotlela has also updated the committee on the use Ivermectin, saying there was no positive findings on the effectiveness of the drug.

She said there was currently no evidence that Ivermectin reduced hospital admissions and death.

Semete-Makokotlela said the drug was also not registered in South Africa for human use.

“So, as we sit, there is no evidence that shows the clinical benefit and our position remains to be that it should be used under controlled mechanism and one of the controlled mechanism is either through a randomised clinical trial wherein it’s being evaluated.”

Current evidence from pooled studies is still not conclusive whether Ivermectin confers any clinical benefits in COVID-19.

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