JOHANNESBURG (Reuters) – South Africa’s health regulator on Thursday reported a causal link between one person’s death and Johnson & Johnson’s (J&J) COVID-19 vaccine, the first time such a direct link has been reported in the country laid.
The person presented with the rare neurological condition Guillain-Barre syndrome shortly after receiving the J&J 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 Guillain-Barre Syndrome (GBS) could be identified,” said Professor Hannelie Meyer.
The age of the person and other personal details have not been disclosed for confidentiality reasons.
Last July, US authorities added a warning to a fact sheet for J&J’s vaccine, stating that data suggested there was an increased risk of GBS in the six weeks after vaccination. At the time, it recorded 100 preliminary reports of GBS in vaccine recipients, including 95 serious cases and one reported death.
J&J did not immediately respond to an email request for comment. The company said at the time of the US warning that it was in talks with regulators and that the number of reported cases of GBS in recipients of J&J vaccines only slightly exceeded the background 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 context, we have administered approximately 9 million (doses) of the Janssen (J&J) vaccine, and this is the first causally linked case of GBS.”
The European drug 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 press conference that just over 6,200 “adverse events” had been reported to SAHPRA from the more than 37 million COVID vaccine doses administered in the country by mid-July, corresponding to by 0.017%.
Semete-Makokotlela said the regulator had assessed about 160 deaths since the introduction of the COVID vaccination, but so far had not seen a causal relationship to vaccination.
South Africa has used injections from J&J and Pfizer in its COVID vaccination campaign. The rollout got off to a slow start due to inventory security issues and lengthy negotiations with pharmaceutical companies, but has recently slowed down due to hesitation.
About 46% of the adult population of 40 million people is now fully vaccinated.
(Reporting by Alexander Winning; editing by Mark Potter)