South Africa's drug regulator has reported two fatal cases of Guillain-Barré syndrome (GBS), a rare neurological disorder, in people who received the anti-Covid vaccine from the U.S. laboratory Johnson & Johnson (J&J).
The Health Authority (SAHPRA) reported the first death on August 4.
"SAHPRA has been informed of a second fatal case of Guillain-Barré syndrome after vaccination with the vaccine against Covid-19 of Janssen," it said Monday in a statement.
J&J stressed in a written response Tuesday that "very rare cases of the neurological disorder, Guillain-Barré syndrome, have been reported after vaccination with Janssen's Covid-19 vaccine, most occurring within the first 42 days after vaccination."
"GBS is a very rare but serious adverse event that is associated with the administration of various vaccines and other drugs and can also be triggered by infections such as SARS-CoV-2," the company added, without directly referring to the South African cases.
SAHPRA did not give more details on the deceased patients, invoking "medical confidentiality".
However, it noted in its statement that "the effects reported in the vaccinated person corresponded to the definition of a GBS case and no other probable cause of GBS were identified".
Guillain-Barré syndrome is a peripheral nerve disorder characterized by progressive weakness and paralysis, most often beginning in the legs and sometimes progressing to the respiratory muscles and then to the nerves of the head and neck.
South Africa, officially the African country most affected by the pandemic has recorded more than four million cases of coronavirus and 102,129 deaths.
Of the population of 60 million, 20.3 million South Africans have been vaccinated. More than 9.2 million received the J&J vaccine and 12.5 million received the Pfizer vaccine, according to official figures.