One person has died after having the Janssen or Johnson & Johnson vaccine, said the South African Health Products and Regulatory Authority (Sahpra) last Thursday, adding this was the first death directly linked to the jab.
CEO Tumi Semete said about 9m South Africans have had the J&J vaccine and this is the first death associated with inoculations. About 37.5m people have been vaccinated altogether, including with the other products on offer, reports TimesLIVE.
Semete said the patient developed Guillain-Barré Syndrome (GBD), a rare disorder in which the body’s immune system attacks the nerves.
It can be caused by a viral or bacterial infection, and was flagged by the US Food and Drug Administration (FDA) in 2021 as a potential risk associated with the J&J vaccine. Cases range from mild to severe and are occasionally fatal, reports BusinessLIVE.
National immunisation safety expert committee chair Prof Hannelie Meyer said GBS is a known possible symptom from taking the J&J COVID-19 vaccine and is included as a contraindication in the product’s information.
“We found evidence of GBS (in the SA patient). We know it’s a rare event but it was diagnosed in this case. Anything else could be responsible for GBS, but in this case there was no other cause,” she said. “It happened soon after the vaccination.”
She said the case involved prolonged hospitalisation, where the person needed mechanical ventilation. The ventilation application caused further complications and infections leading up to death.
“GBS is classified as a vaccination product reaction, and there was no other likely cause of GBS in this case.”
Minister of Health Dr Joe Phaahla said though adverse events do occur after vaccinations, most are mild and end in a few days.
He said there had been 6,200 adverse events reported to Sahpra, equating to 0.017% of the vaccinated population. He said if links to the vaccine were found, there would be compensation.
Meyer added: “Having looked at an ongoing review of vaccine safety and ongoing review of the potential risk of Guillain-Barré, we are strongly convinced that the benefits of the COVID-19 vaccine in preventing serious and severe infections and mortality greatly outweigh the very, very rare risk of other adverse events. However, we are committed to the ongoing review and analysis of all adverse events reported to us.”
She added that once an adverse event was reported, they need to also ensure it was the correct diagnosis. “Anaphylaxis as an example. It is a serious and rare event, but when we investigate the case we find the person has a bad rash but reported anaphylaxis. Thus we can’t really say (today) how many cases there have been because we are still investigating the cases.”
She said 70% of the cases reported for the J&J and the Pfizer vaccine turned out to be coincidental, 10% are unclassified cases where they do not know the cause, and about 3% of the cases were caused by stress related to the process of getting the vaccine.
Semete added that investigations and causality assessment of all severe reported adverse events after immunisation with the Janssen and other COVID vaccines are ongoing.
IOL article – One person dies after taking J&J vaccine – Sahpra confirms (Open access)
BusinessLIVE article – SA reports first death triggered by J&J Covid-19 shot (Open access)
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