“SAHPRA has been notified of a fatal case of Guillain-Barre syndrome [GBS, na sigla em inglês] after vaccination with the Janssen covid-19 vaccine,” the South African Institute of Health announced in a statement.
“The causality assessment of the reported case was conducted by NISEC [National Immunisation Safety Expert Committee] Using the World Health Organization (WHO) methodology, “this case was classified as an event related to the vaccine product, revealing that vaccination with the Janssen Covid-19 vaccine was associated with a GBS event in a vaccine recipient”.
“The reported events in the vaccine recipient were consistent with the case definition for GBS, and no other cause of GBS was identified at the time of illness,” he noted. According to the South African Regulatory Authority, Guillain-Barre syndrome is “a very rare but serious adverse event associated with the administration of various vaccines and other drugs and can also be triggered by infections such as SARS-CoV. -two”.
“GPS is a rare condition that affects the body’s immune system” and symptoms “can range from mild to severe and include muscle weakness, muscle pain, numbness and tingling,” the health official explained. It is a serious autoimmune disease that is mainly caused by infection, most often as a result of Zika virus infection.
“In many cases, GBS improves without serious adverse effects, but in some cases GBS can worsen and cause stroke 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 with a primary vaccine dose for people 18 years of age and older. “The Janssen covid-19 vaccine was 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 multivalent booster dose after completing primary vaccination with a different covid-19 vaccine,” he said.
The Johnson & Johnson vaccine is one of the national vaccination programs against Covid-19 launched by the South African government on May 17, 2021. To date, 9,135,189 doses of Janssen vaccine against Covid have been administered. -19 in South Africa, according to a note from the South African Regulatory Commission.
“Regulatory authorities have already examined GPS reports related to Covid-19 vaccines. In July 2021, the European Medicines Agency reviewed 108 suspected GBS cases globally, after 21 million people had received the Janssen Covid-19 vaccine. They concluded that there is a high risk and causal relationship between GBS and the Janssen Covid-19 vaccine.
For this reason, in July 2021, in the vaccine information, these side effects were a very rare adverse effect of the Covid-19 vaccine Johnson, warning medical professionals and the vaccinated about the possibility of this event.