South Africa reports its first death causally linked to a COVID vaccine

JOHANNESBURG (Reuters) – South Africa’s health regulator on Thursday reported a causal link between a person’s death and Johnson & Johnson (J&J) disease. (JNJ.N) A COVID-19 vaccine, the first time such a direct link has been established in the country.

Leading scientists told a news conference that the person developed the rare neurological disorder Guillain-BarrĂ© syndrome shortly after receiving J&J’s Janssen vaccine, after which the person was placed on a ventilator and later died.

“At the time of the illness it was not possible to identify another cause of Guillain-BarrĂ© syndrome (GBS),” said Professor Hanele Meyer.

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The person’s age and other personal data are not disclosed for confidentiality reasons.

J&J said in an email statement that GBS is 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 has strongly supported increased awareness of the signs and symptoms of rare events to ensure they can be recognized quickly and effectively treated.

Last July, US authorities added a warning to the J&J vaccine fact sheet saying that data indicated an increased risk of GBS in the six weeks after vaccination. At the time, it noted 100 initial reports of GBS in vaccine recipients, including 95 serious cases and one reported death. Read more

J&J said at the time of the US warning that it was in discussions with regulators and that the rate of reported cases of GBS in Janssen vaccine recipients slightly exceeded the base rate. Read more

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“The benefit of vaccination still far outweighs the risks,” Boitumelo Semete-Makokotlela, chief executive of the South African Health Products Regulatory Authority (SAHPRA) told reporters.

“In our context, we have administered about 9 million (dose) of the Janssen vaccine, and this is the first case causally linked to GBS.”

Europe’s drug regulator last year added GBS as a potential side effect of AstraZeneca’s COVID vaccine which, like J&J, uses virus vector technology. Read more

As of mid-July, South Africa’s Health Minister Joe Vahla said that as of mid-July, there had been more than 6,200 “adverse events” reported to SAHPRA out of more than 37 million doses of the COVID vaccine administered in the country, i.e. what Equivalent to 0.017%.

Semete-Makokotlela said the regulator has evaluated about 160 deaths since the launch of the COVID vaccine, but has not seen a causal link to vaccination yet.

South Africa is using shots from J&J and Pfizer in its coronavirus vaccination campaign. The launch process has been slow due to difficulties in securing supplies and lengthy negotiations with pharmaceutical companies, but lately it has been slowed by reluctance.

About 46% of its adult population of 40 million is now fully vaccinated.

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(Reporting by Alexander Winning) Editing by Mark Potter

Our criteria: Thomson Reuters Trust Principles.

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