South Africa’s health regulator has established a link between vaccines and rare diseases.
On Thursday, South African health authorities said they had – for the first time – established a direct link between the death of an individual and Johnson & Johnson’s Covid-19 vaccine.
The South African Health Products Regulatory Authority (SAHPRA) said in a statement it was informed of a fatal case of a rare neurological disorder called Guillain-Barre Syndrome (GBS) following vaccination with J&J’s Janssen vaccine.
The patient’s personal details were not disclosed due to confidentiality considerations.
Boitumelo Semete–Makokotlela, CEO of SAHPRA said that the causality analysis was done in strict compliance with WHO’s methodology. “a vaccine product-related event.”
“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,”She said.
According to the official, SAHPRA had already assessed 160 cases of death since Covid’s vaccination campaign began in South Africa. However, they had not established a causal relationship between the deaths and the vaccination.
“GBS 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,”Semete Makokotlela stated that vaccines are still very beneficial and far more effective than the dangers.
Reuters reported that J&J pointed out in an emailed comment that GBS was associated with a number of vaccines and other medicines, and can be triggered by SARS-CoV-2 – the virus that causes Covid-19.
As Semete-Makokotlela explained to reporters, GBS is a rare condition affecting the body’s immune system, causing various mild-to-severe symptoms, including muscle weakness, muscle pain, numbness, and tingling. Although the majority of cases resolve without serious side effects in most cases, it can cause paralysis or other serious symptoms.
Last year, authorities in the US added a warning about an increased risk of GBS in the 42 days following vaccination to FDA’s factsheet for J&J’s Covid-19 vaccine.