South Africa’s health regulator on Thursday announced 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.A person had the rare neurological disorder Guillain-Barre syndrome soon after being given J&J’s vaccine, after which the person was put on a ventilator and later died, lead researchers said at a news conference.”No other cause of Guillain-Barre syndrome (GBS) could be identified at the time of illness,” said Professor Hannelie Meyer.
The person’s age and other personal details have not been disclosed for reasons of confidentiality.Last July, US authorities added a warning to the J&J vaccine fact sheet that data suggested an increased risk of GBS within six weeks of vaccination. At that time, it had 100 preliminary reports of GBS in vaccine recipients, including 95 serious cases and one reported death.J&J did not immediately respond to an emailed request for comment. The company said at the time of the US warning that it was in discussions with regulators and that the rate of reported GBS cases in recipients of the J&J vaccine was only slightly above the baseline rate.
“The benefit of vaccination still far outweighs the risk,” BoitumeloSemete-Makokotlela, executive director of the South African Health Products Regulatory Authority (SAHPRA), told reporters.”In our context, we have administered about 9 million (doses) of the Janssen (J&J) vaccine, and this is the first causally linked case of GBS.”The European medicines regulator last year added GBS as a possible side effect of AstraZeneca’s Covid vaccine, which, like J&J, uses viral vector technology.
South African Health Minister Joe Phaahla told a press conference on Thursday that as of mid-July, just over 6,200 “adverse events” had been reported to SAHPRA out of more than 37 million doses of the Covid vaccine administered in the country, equivalent to 0.017%.Semete-Makokotlela said the regulator had assessed around 160 deaths since the introduction of the Covid vaccination, but had not yet seen a causal link to the vaccination.
South Africa uses footage from J&J and Pfizer in its Covid vaccination campaign. The rollout got off to a slow start due to difficulties in securing supplies and protracted negotiations with pharmaceutical companies, but has recently been slowed by hesitancy. About 46% of the adult population of 40 million are now fully vaccinated.
