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South Africa’s health regulator reported on Thursday a causal relationship between a person’s death and Johnson & Johnson’s (J&J) illness. COVID-19 vaccines, such a direct link was established in the country for the first time.
A person with a rare neurological disorder Guillain-Barré syndrome shortly after he was injected with the J&J Janssen vaccine, after which the man was put on a ventilator and later died, leading scientists said at a press conference.
“At the time of illness, no other causes of Guillain-Barré syndrome (GBS) could be identified,” said Professor Hannely Meyer.
The person’s age and other personal details are not disclosed for privacy reasons.
J&J said in an emailed statement that GBS has been associated with the administration of various vaccines and other medications and may also be caused by SARS-CoV-2, the virus that causes COVID-19.
The company said it strongly supports raising awareness of the signs and symptoms of rare events so they can be quickly identified and treated effectively.
Last July, US authorities added a warning to the J&J Vaccine Fact Sheet stating that evidence suggests an increased risk of GBS up to six weeks after vaccination. At that time, he had 100 preliminary reports of GBS in vaccine recipients, including 95 serious cases and one reported death.
J&J said it was negotiating with regulators at the time of the US alert and the rate of reported cases of GBS in Janssen vaccine recipients was only slightly above background levels.
“The benefits of vaccination still far outweigh the risks,” Boitumelo Semete-Makokotlela, executive director of the South African Health Products Regulatory Authority (SAHPRA), told reporters.
“In our context, we have administered about 9 million (doses) of the Janssen vaccine and this is the first causal case of GBS.”
The European Medicines Regulator added GBS as a possible side effect last year. AstraZeneca COVID Vaccine which, like J&J, uses viral vector technology.
South African Health Minister Joe Fahla said at a press conference on Thursday that just over 6,200 “adverse events” had been reported to SAHPRA as of mid-July, out of more than 37 million doses of COVID vaccine administered in the country, equivalent to 0.017%.
Semete-Makokotlela said the regulator has estimated about 160 deaths since the start of the COVID vaccination rollout, but so far has not seen a causal relationship to the vaccination.
South Africa is using vaccines from J&J and Pfizer in its COVID vaccination campaign. Implementation started slowly due to supply chain difficulties and protracted negotiations with pharmaceutical companies, but has slowed recently due to indecision.
About 46% of the adult population of 40 million are now fully vaccinated.