South Africa’s health regulator has established a causal link between vaccination and a fatal case of a rare disease
On Thursday, South African health authorities said they had – for the first time – established a direct link between an individual’s death and Johnson & Johnson’s Covid-19 vaccine.
The South African Health Products Regulatory Authority (SAHPRA) said in a statement that it had been made aware of a fatal case of a rare neurological disorder called Guillain-Barré syndrome (GBS) following a vaccination with J&J’s Janssen vaccine.
The patient’s personal data was not disclosed for reasons of confidentiality.
SAHPRA CEO Boitumelo Semete-Makokotlela said a causality assessment, conducted in full compliance with the methodology set out by the World Health Organization (WHO), concluded that the case was indeed “an event related to a vaccine product”.
“The events reported in the vaccine recipient met the case definition for GBS and no other probable cause of GBS was identified at the time of illness,” she says.
SAHPRA had assessed about 160 deaths since the start of the Covid vaccination campaign in South Africa but had never established a causal link between a death and vaccination until now, the official said.
“GBS is a very rare but serious adverse event that is associated with the administration of various vaccines and other medications and can also be triggered by infections,” Semete-Makokotlela emphasized, adding that the benefits of vaccination still far outweigh the risks.
Reuters reported that J&J pointed out in an emailed comment that GBS was associated with a number of vaccines and other drugs, and could be triggered by SARS-CoV-2 – the virus that causes Covid-19. 19.
As Semete-Makokotlela explained to reporters, GBS is a rare disease affecting the body’s immune system, causing a variety of mild to severe symptoms, including muscle weakness, muscle pain, numbness and tingling. In many cases, the syndrome resolves without serious side effects, but it can become severe and cause paralysis and other life-threatening symptoms.
Last year, US authorities added a warning about an increased risk of GBS within 42 days of vaccination to the FDA’s fact sheet for J&J’s Covid-19 vaccine.