South Africa reports first death causally linked to COVID vaccine

JOHANNESBURG, Aug 4 (Reuters) – South Africa’s health regulator on Thursday reported a causal link between the death of an individual and Johnson & Johnson’s (J&J) (JNJ.N) COVID-19 vaccine, the first time such a direct link is established. made in the country.

The person developed a rare neurological disorder, Guillain-Barre Syndrome, shortly after receiving J&J’s Janssen vaccine, after which the person was put on a ventilator and later died, senior scientists said at a news conference.

“At the time of illness, no other cause of Guillain-BarrĂ© syndrome (GBS) could be identified,” said Professor Hannelie Meyer.

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The person’s age and other personal details were withheld for confidentiality reasons.

J&J said in an emailed statement that GBS was associated with the administration of various vaccines and other medications and can also be triggered 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 to ensure they can be quickly identified and treated effectively.

Last July, US authorities added a warning to a J&J vaccine fact sheet that said the data suggested there was an increased risk of GBS in the six weeks after vaccination. At the time, it noted 100 preliminary reports of GBS in vaccine recipients, including 95 severe cases and one reported death. read more

J&J said that at the time of the US warning it was in talks with regulators and that the rate of reported cases of GBS in Janssen vaccine recipients only slightly exceeded the baseline rate. read more

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

“In our setting, we have administered about 9 million (doses) of the Janssen vaccine, and this is the first causally related case of GBS.”

Last year, Europe’s drug regulator added GBS as a possible side effect of AstraZeneca’s COVID vaccine, which, like J&J’s, uses viral vector technology. read more

South African Health Minister Joe Phaahla said at Thursday’s press conference that as of mid-July, just over 6,200 “adverse events” had been reported to SAHPRA out of the more than 37 million doses of COVID vaccine administered. in the country, equivalent to 0.017%.

Semete-Makokotlela said the regulator had assessed around 160 deaths since the rollout of COVID vaccination began, but had not seen a causal link to vaccination until now.

South Africa has been using injections from J&J and Pfizer in its COVID vaccination campaign. The launch got off to a slow start due to difficulties securing supplies and lengthy negotiations with drug companies, but more recently has been slowed down by hesitation.

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

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