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South African health officials Thursday reported a causal link between the death of an individual and Johnson & Johnson’s (J&J) COVID-19 vaccine.
The man developed Guillain-Barré syndrome, a rare neurological disease, shortly after being vaccinated with J&J’s Janssen vaccine and then died after being put on a ventilator, senior scientists told a news conference.
“At the time of illness, no other cause of Guillain-Barré syndrome (GBS) could be identified,” said Professor Hannelly Meyer.
Due to confidentiality, age and other personal information is not disclosed.
FDA warns Johnson & Johnson COVID-19 vaccine could lead to rare disease
In an emailed statement, J&J said GBS is associated with administration of various vaccines and other medicines and can also be caused by SARS-CoV-2, the virus that causes COVID-19. says.
The company said it strongly supports raising awareness of the signs and symptoms of rare events so that they can be identified quickly and treated effectively.
Last July, US officials added a warning to J&J’s vaccine factsheet, saying the data suggested an increased risk of GBS six weeks after vaccination. At that time, his 100 preliminary reports of GBS in vaccinated persons included his 95 severe cases and his 1 fatal case.
J&J said at the time of the U.S. alert, it was in consultation with regulators and the proportion of reported cases of GBS among Janssen vaccinees was only slightly above background proportions.
“The benefits of vaccination far outweigh the risks,” Boitumero Semete Makotolera, CEO of the South African Health Products Regulatory Agency (SAHPRA), told reporters.
“In our situation, we have administered about nine million doses of the Janssen vaccine, and this is the first causal case of GBS.”
European drug regulators last year added GBS as a possible side effect of AstraZeneca’s COVID vaccine, which like J&J uses viral vector technology.
South Africa’s Health Minister Joe Faarah said at a press conference on Thursday that as of mid-July, of the more than 37 million doses of the COVID vaccine administered in the country, 6,200 “adverse events” had been reported to SAHPRA. It said that it slightly exceeded the number of cases, which is equivalent to 0.017%.
Right and Left Warn of Johnson & Johnson Vaccine Links to Rare Diseases
Semete-Makokotlela said regulators have assessed about 160 deaths since the COVID vaccination rollout began, but have so far found no causal link to vaccination.
South Africa is using J&J and Pfizer shots in its COVID vaccination campaign. The rollout got off to a slow start as supply was difficult to secure and negotiations with pharmaceutical companies dragged on, but hesitation has slowed it down recently.
About 46% of the 40 million adult population are now fully vaccinated.