The South African Health Products Regulatory Authority (Sahpra) has reported a fatal case of Guillain-Barré syndrome (GBS) following vaccination with Johnson & Johnson’s Covid-19 Janssen vaccine. This is the first reported link between the death of an individual and a Covid vaccine in this country.
GBS is a rare disorder in which the body’s immune system attacks the nervous system, causing muscle weakness and potential paralysis. It can be caused by a viral or bacterial infection.
The symptoms of GBS can vary from mild to severe, and include muscle weakness, muscle pain, numbness and tingling, Sahpra said in a statement.
In many cases, GBS gets better with no serious after-effects, but in some cases, GBS can cause paralysis and other serious or life-threatening problems, such as breathing problems and abnormal blood pressure or heart rate. GBS-associated paralysis can require intensive care with ventilatory support, which can be complicated by life-threatening infection.
According to Professor Marc Blockman, the chairperson of Sahpra’s pharmacovigilance committee, GBS affects 100 000 people globally each year.
Last year, the US Food and Drug Administration added a warning to a factsheet for J&J’s vaccine, saying data suggested there was an increased risk of GBS in the six weeks after vaccination. At the time, it noted 100 preliminary reports of GBS in vaccine recipients, including 95 serious cases and one reported death.
Also last year, the European Medicines Agency conducted a review of 108 suspected cases of GBS reported worldwide after 21 million people had received the J&J vaccine. They concluded that there was a possible increased risk and causal relationship between GBS and the J&J vaccine.
The agency also added GBS as a possible side-effect of AstraZeneca’s Covid vaccine, which, like J&J’s, uses viral vector technology.
Saphra’s statement said GBS is associated with the administration of various vaccines and other medicines and can be triggered by infections, such as Covid-19.
Nisec investigation into the death
In its report on the fatality in South Africa, the regulator said the person presented with GBS soon after being given J&J’s Janssen vaccine, after which the patient was put on a ventilator and later died.
Sahpra did not reveal any details about the patient.
“The events reported in the vaccine recipient were consistent with the case definition for GBS, and no other likely cause of GBS was identified at the time of illness,” the regulator said.
The case was investigated by the National Immunisation Safety Expert Committee (Nisec) using the World Health Organization’s methodology.
Nisec is tasked with reviewing and assessing severe adverse events reported after immunisation, to establish whether or not they are associated with the use of a vaccine.
The committee’s chairperson, Professor Hannelie Meyer, said the investigation “classified this event as a vaccine product-related reaction and a result of the Covid-19 vaccine. We also found that the events following the vaccination could not be linked to any other cause of GBS.”
6 204 ‘adverse events’ following vaccination
Sahpra chief executive Boitumelo Semete-Makokotlela said about 160 deaths have been assessed since the start of the Covid vaccine roll-out, and it was only now that a causal link to vaccination has been made.
To date, more than 37.5 million vaccine doses have been administered in South Africa, of which 9 135 189 were doses of the Janssen vaccine.
Health Minister Dr Joe Phaahla said that as of 15 July, 6 204 “adverse events” following immunisation had been recorded to Nisec out of the 37.2 million Covid vaccine doses administered in the country by that date. This was equivalent to 0.017% “adverse events”.
Dr Phaahla described an “adverse event” following immunisation as any unforeseen medical event that follows a vaccine. It did not necessarily have a causal relationship with the use of the vaccine.
“This may be an unfavourable or unintended sign, abnormality, symptoms or disease. Most adverse events following immunisation are mild and resolved within a few days,” he said.
Business Day reported that of the 6 204 cases, only “a small fraction” have been found to have suffered an injury caused by a Covid-19 vaccine, a key requisite if they want to lodge a claim with the government’s Covid-19 vaccine injury no-fault compensation scheme.
The publication quoted Dr Nicholas Crisp, the Department of Health’s deputy director-general for National Health Insurance and who has been closely involved with the vaccination programme, as saying the department was aware of 75 potential claimants, but none had yet lodged a claim.
“The rule is that Nisec communicates the findings to the health department, and someone is appointed to inform the patient (or) family. The no-fault compensation scheme communicates with the patient (or) family after that to ask if they wish to lodge a claim. We are at that point now with two people,” Dr Crisp was quoted as saying.
Vaccine benefits outweigh the risks, says regulator
Blockman said 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. Semete-Makokotlela agreed with him.
The chairperson of Sahpra’s board, Professor Helen Rees, said: “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.”
Rees said casualties were “very rare” with the J&J vaccine.
“I think most people in this country by now will know somebody who has died of Covid, so the benefit of vaccines and preventing severe disease and death is very significant. 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.”
Meyer said: “Having looked at an ongoing review of vaccine safety and ongoing review of the potential risk of Guillain-Barré, we are convinced and strongly convinced that the benefits of the Covid-19 vaccine in terms of preventing serious and severe Covid-19 infections and mortality greatly outweigh the very, very rare risk of some or other adverse events.
“However, we are committed to the ongoing review and analysis of all adverse events that are reported to us.”
Sahpra approval
In March last year, Sahpra approved the use of the Janssen vaccine for individuals aged 18 and older as a single primary vaccination dose.
Later, it was approved as a single booster dose given at least two months after the primary vaccination dose. In December 2021, it was approved as a heterologous booster dose following completion of primary vaccination with a different Covid-19 vaccine.
6 of my clients, healthy 30 something year olds, died shortly after having the injection. One 22 year old suffered a stroke hours after. The medical “profession” are protecting their income by not coming forward and I would venture that Sahpra do not know what day of the week it is or at least are hiding the facts.