The South African patient got vaccinated against the coronavirus, choosing the Johnson & Johnson Covid-19 jab. But what happened soon after had everyone stumped and many health professionals floored.
The patient developed Guillain Barré Syndrome (GBS), one of the possible side effects of the Janssen Covid-19 vaccine.
A mere 100 000 people, globally, are affected by this disease a year – and few of them die from it.
What is even more puzzling about this SA patient, whose details were withheld, is that they seemed relatively healthy and had no other diseases which could have led to their sudden death.
“At the time of illness, no other cause of Guillain-Barré was discovered in this person,” National Immunisation Safety Expert Committee (NISEC) chairperson Professor Hannelie Meyer told News24, adding that the patient presented symptoms of GBS fairly soon after vaccination and required hospitalisation and was on a ventilator.
“It led to further complications and infections and eventually led to death.”
South African Health Products Regulatory Authority (Sahpra) also confirmed the person’s death on Thursday, announcing: “Sahpra has been informed of a fatal case of [GBS] following vaccination with Covid-19 Vaccine Janssen.”
GBS, Sahpra added, “is a very rare but severe adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by infections such as SARS-CoV-2”.
That was in August. Now Sahpra has announced that yet another person has died from the vaccine, after developing the exact same disorder.
In a statement, Sahpra chief executive Dr Boitumelo Semete-Makokotlela said a second fatal case of Guillain-Barré syndrome (GBS) had been confirmed.
"Causality assessment of the reported case was conducted by the National Immunisation Safety Expert Committee (NISEC) using the World Health Organisation's (WHO) methodology. The case was classified as a vaccine product-related event following investigations conducted and causality assessment," News24 reported.
"The events reported in the vaccine recipient were consistent with the case definition of GBS, and no other likely cause of GBS was identified at the time of illness. As previously communicated, GBS is a very rare but potentially severe neurological adverse event that is associated with the administration of various vaccines and other medicines and can also be triggered by some bacterial or viral infections, including SARS-CoV-2."
Following the South African government’s decision in June to scrap Covid-19 lockdown regulations, including the wearing of masks indoors, as the number of active cases seemed to be going down, many of us heaved a huge sigh of relief.
At last, we thought. We have defeated the coronavirus, and now life can go back to normal.
The government’s decision in July to stop providing daily updates of people who tested positive and daily Covid-19 deaths made many of us feel even more relieved.
From 1 August, the Health Department and the National Institute for Communicable Diseases (NICD) would publish the Covid-19 surveillance data only weekly, they said.
“Due to the reduced severity and transmissibility of the disease at the current moment, coupled with declining Covid-19 case numbers, the department together with the NICD has reassessed the existing reporting structures and agreed that it is justifiable to allow the majority of members of the reporting structures return to their permanent jobs on a full-time basis,” the department said, explaining its decision.
The government had the NICD’s full support in this decision and the SA communicable disease institute agreed that the phase of the pandemic the country is in no longer requires daily Covid-19 updates.
But the public should not take this announcement, made on Sunday 31 July to the media, to mean that the pandemic is over, the department warned.
Now, these cases of Covid-19 vaccine related deaths have made some people, again, wonder how safe it is.
The short answer, according to Professor Marc Blockman, chairperson of Sahpra’s Pharmacovigilance Committee, is very safe.
“From our point of view, the benefits of the COVID-19 vaccine, in terms of preventing serious and severe infections and death, greatly outweigh the rare risk of GBS and other adverse events.”
Professor Helen Rees, Chair of the SAHPRA board, echoed the same sentiment in a report by Health-e News. “In South Africa, we lost over 100,000 people because of Covid-19.
“The virus particularly affects those who are older or have comorbidities. The one thing all the vaccines do very well is preventing severe disease and death.
“But as the regulator, our responsibility is to explain what happened in this case and reassure the public that we are looking at all the incidents.”
The risk of contracting vaccine-related side-effects that could lead to death remains minimal, experts agree.
The regulator would be consulting with the World Health Organisation, J&J and other parties concerned to determine if there was a universal pattern of vaccine-related deaths linked to GBS, Prof Rees added.
In an emailed statement to Reuters, J&J said that “GBS was associated with the administration of various vaccines and other medicines and can also be triggered by SARS-CoV-2, the virus that causes Covid-19”.
“The known and potential benefits of the [vaccine] outweigh the known and potential risks of [it],” said the US Food and Drug Administration (FDA) in July last year when it emerged that cases of GBS had been reported following vaccination with the J&J single-dose vaccine.
These are some of the potential symptoms of Guillain-Barré syndrome (GBS), according to the FDA, which in July 2021 added a warning about GBS to its J&J jab fact sheets about the vaccine.
- Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body.
- Difficulty walking.
- Difficulty with facial movements, including speaking, chewing, or swallowing.
- Double vision or inability to move eyes.
- Difficulty with bladder control or bowel function.
“These may not be all the possible side effects of the Janssen Covid-19 vaccine,” agency added.
“Serious and unexpected effects may occur.”
The most important thing is that people need to closely monitor an symptoms after getting jabbed and get medical assistance as soon as possible.
“In most of these people, symptoms began within 42 days following receipt of the Janssen Covid-19 vaccine,” says the agency.
“The chance of having this occur is very low. You should seek medical attention right away if you develop any of [the above] symptoms after receiving the Janssen Covid-19 Vaccine.”