South Africa's health regulator reported on Thursday a causal link between the death of an individual and Johnson & Johnson's (J&J) COVID-19 vaccine, the first time such a direct link has been made in the country.
The person presented with rare neurological disorder Guillain-Barre Syndrome soon after being given J&J's Janssen vaccine, after which the person was put on a ventilator and later died, senior scientists told a news conference.
"At the time of illness no other cause for the Guillain-Barre Syndrome (GBS) could be identified," Professor Hannelie Meyer said.
The person's age and other personal details were not disclosed for confidentiality reasons.
J&J said in an emailed statement that GBS was associated with the administration of various vaccines and other medicines and can also be triggered by SARS-CoV-2, the virus that causes COVID-19.
The company said it strongly supported raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.
Last July, U.S. authorities added a warning to a factsheet for J&J's vaccine saying 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 serious cases and one reported death.
J&J said at the time of the U.S. warning it was in discussions with regulators and the rate of reported cases of GBS in Janssen vaccine recipients exceeded the background rate only slightly.
"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 context we have administered about 9 million (doses) of the Janssen vaccine, and this is the first causally linked case of GBS."
Europe's medicines regulator last year added GBS as a possible side-effect of AstraZeneca's COVID vaccine which, like J&J's, uses viral vector technology.
South Africa's Health Minister Joe Phaahla told Thursday's news conference that as of mid-July there had been just over 6,200 "adverse events" reported to SAHPRA out of the more than 37 million COVID vaccine doses administered in the country, equivalent to 0.017%.
Semete-Makokotlela said the regulator had assessed around 160 deaths since the COVID vaccination rollout started but had not seen a causal link to vaccination until now.
South Africa has been using shots from J&J and Pfizer in its COVID vaccination campaign. The rollout got off to a slow start due to difficulties securing supplies and protracted negotiations with pharmaceutical companies, but more recently it has been slowed by hesitancy.
Around 46% of its adult population of 40 million is now fully vaccinated.
(Reporting by Alexander WinningEditing by Mark Potter)
