“SAHPRA has been informed of a fatal case of Guillain-Barré Syndrome. [GBS, na sigla em inglês] after being vaccinated with the Janssen covid-19 vaccine,” the South African health authority said in a statement.
“A causal assessment of the reported case was carried out by NISEC. [National Immunisation Safety Expert Committee] using World Health Organization (WHO) methodology” added a note showing that “the case was classified as a vaccine product event in which immunization with Janssen covid-19 vaccine was associated with GBS. in a vaccine recipient.
“Events reported in the vaccine recipient met the definition of a GBS case, and no other likely cause of GBS was identified at the time of illness,” he noted. Guillain-Barré syndrome “is a very rare but serious adverse event associated with the administration of various vaccines and other drugs, and can also be caused by infections such as SARS-CoV.-two,” according to the South African regulatory authority.
A health spokesman explained that “GBS is a rare disease that affects the body’s immune system” and symptoms “can range from mild to severe and include muscle weakness, muscle pain, numbness and tingling.” This is a serious autoimmune disease that occurs mainly due to infection, often as a result of infection with the Zika virus.
“In many cases, GBS improves without serious side effects, but in some cases, GBS can become severe and cause paralysis and other serious or life-threatening problems, such as breathing problems and abnormal blood pressure or heart rate,” he added.
On March 31, 2021, SAHPRA approved the use of the Janssen Covid-19 vaccine in South Africa for those aged 18 years and over with a single dose primary vaccination. “The Janssen covid-19 vaccine was subsequently approved as a single booster dose given at least two months after the primary vaccine dose. On December 22, 2021, it was approved as a heterologous booster after completion of primary vaccination with another COVID-19 vaccine,” he said.
The Johnson & Johnson vaccine is one of the immunizations included in the national covid-19 vaccination plan that the South African government launched on May 17, 2021. in South Africa, according to a note from the South African regulator.
“Regulators have already investigated reports of GBS related to COVID-19 vaccines. In July 2021, the European Medicines Agency reviewed 108 cases of suspected GBS reported worldwide after 21 million people received the Janssen covid-19 vaccine. They concluded that there is a possible increased risk and causal relationship between the occurrence of GBS and the Janssen covid-19 vaccine.”
For this reason, in July 2021, Infarmed included these side effects in the vaccine information as a very rare adverse event for the Janssen COVID-19 vaccine, alerting healthcare professionals and vaccinated people to the possibility of this event occurring.