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South Africa’s health regulator on Thursday reported a causal link between an individual’s death and Johnson & Johnson’s (J&J) COVID-19 vaccine, the first time such a direct link has been established in the country. .

The person developed a rare neurological disorder, Guillain-Barré syndrome, shortly after receiving J&J’s Janssen vaccine, after which the person was put on a ventilator and later died, top scientists said during a press conference.

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

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

FDA WARNS POTENTIAL LINK OF JOHNSON & JOHNSON COVID-19 VACCINE TO RARE DISORDER

J&J said in an emailed statement that GBS is 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 J&J vaccine has been linked to a death for the first time in South Africa. Pictured: A healthcare worker administers a dose of coronavirus vaccine in Johannesburg, South Africa, December 4, 2021.
(REUTERS/Sumaya Hisham)

The company said it strongly supports raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.

Last July, U.S. officials added a warning to a J&J vaccine fact sheet that data suggested there was an increased risk of GBS within six weeks of vaccination. At the time, he noted 100 preliminary reports of GBS in vaccinees, including 95 severe cases and one reported death.

J&J said at the time of the US warning, it was in discussions with regulators and the rate of reported cases of GBS in recipients of the Janssen vaccine was only slightly above the baseline rate.

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

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

Last year, the European medicines regulator added GBS as a possible side effect of AstraZeneca’s COVID vaccine which, like J&J’s, uses viral vector technology.

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

RIGHT AND LEFT WARNINGS ABOUT JOHNSON & JOHNSON VACCINE LINK TO RARE DISEASES

Semete-Makokotlela said the regulator had assessed around 160 deaths since the start of the COVID vaccination rollout but had not seen a causal link to the vaccination so far.

South Africa used vaccines from J&J and Pfizer in its COVID vaccination campaign. The rollout got off to a slow start due to supply difficulties and protracted negotiations with pharmaceutical companies, but more recently has been slowed by hesitation.

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

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