Covid-19 vaccine Janssen claims one life in South Africa

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Janssen was one of the vaccines provided in the national roll-out, which commenced on May 17 2021 and to date had administered in over 9.1 million doses in South Africa. Photo: Samantha Zucchi/Insidefoto/Mondadori Portfolio via Getty Images
Janssen was one of the vaccines provided in the national roll-out, which commenced on May 17 2021 and to date had administered in over 9.1 million doses in South Africa. Photo: Samantha Zucchi/Insidefoto/Mondadori Portfolio via Getty Images

NEWS


The South African Health Products Regulatory Authority (Sahpra) has reported that one person has died after having the Covid-19 vaccine Janssen administered.

The regulatory authority announced on Thursday morning while providing an update on adverse events following immunisation.

According to Sahpra, Janssen was one of the vaccines provided in the national roll-out, which commenced on May 17 2021 and to date had administered in over 9.1 million doses in South Africa.

CEO Dr Boitumelo Semete-Makokotlela said Sahpra had been informed of a fatal case of Guillain-Barré syndrome following vaccination with the Janssen vaccine.

Semete-Makokotlela said: 

Causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organisation’s methodology. The case was classified as a vaccine product-related event, where immunisation with the Janssen vaccine was associated with the occurrence of Guillain-Barré syndrome in the vaccine recipient. The events reported in the vaccine recipient were consistent with the case definition for the syndrome and no other likely cause of Guillain-Barré syndrome was identified at the time of illness.


She explained that the Guillain-Barré syndrome was a rare but severe adverse event that was associated with the administration of various vaccines and other medicines and could also be triggered by infections, such as SARS-CoV-2.

“It is a rare condition affecting the body’s immune system and symptoms can vary from mild to severe, and include muscle weakness, muscle pain, numbness and tingling. In many cases, Guillain-Barré syndrome gets better with no serious after-effects but in some cases, it can become serious and cause paralysis and other serious or life-threatening problems, such as breathing problems and abnormal blood pressure or heart rate. Guillain-Barré syndrome-associated paralysis can require intense care with ventilatory support, which can be complicated by life-threatening infection.”

READ: Covid vaccine prevents death, not infection

She added investigations and causality assessment of all severe reported adverse events following immunisation with the Covid-19 vaccine Janssen and other Covid-19 vaccines were ongoing and an update on the outcome would be shared with the public as they become available.

NISEC CEO Professor Hannelie Meyer said when it comes to Covid-19 vaccinations, an investigation was done by many disciplinary teams in provinces where they collected all the necessary information about the case before the vaccination, as well as what followed the vaccination.

She said: 

With this case, we have discovered that there was evidence of Guillain-Barré syndrome, and we know that this is a very rare event, but it has been diagnosed in this person. We made sure there was no other strong evidence for another course, in other words, anything else that could have been responsible for the syndrome in this person and indeed in this case at the time of illness, there was no other course for the syndrome.


She added it was also important to look at whether this happened during a certain window, and the deceased presented with symptoms soon after vaccination.

We also looked at other qualifying factors involved, including underlying medical conditions or any medication they had been taking at the time of vaccination. In this case, we identified that this person presented with symptoms following vaccination within the specified period and this resulted in prolonged hospitalisation, which required mechanical ventilation, which also led to further complications and resulted in death.


Health Minister Dr Joe Phaahla said most adverse events following immunisation were mild and were resolved within a few days.

“Since the introduction of the Covid-19 vaccine, there had been over 37.2 million doses that had been administered. Up to July 15 this year, just over 6 200 adverse events were reported to Sahpra, which indicated reporting of adverse events of 0.017%. If a serious adverse event is linked to the use of the Covid-19 vaccine, the case will be considered for compensation. Vaccine reporting aims to maintain a high level of vaccine confidence in the public through continuous monitoring of safety.

READ: Editorial | Vaccinate or else...

“Covid-19 vaccine remains very safe and effective in protecting us against serious illness and hospitalisation,” Phaahla said.


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