South Africa

South Africa reports first death causally linked to COVID vaccine

cde.news desk 4 August 2022, 13:20 · 2 min read

epa10074094 A security personnel looks on next to a list of high-risk countries for the Monkeypox virus, as India reported the first case of Monkeypox in the WHO South-East Asia Region, at Chennai International Airport, in Chennai, India, 16 July 2022. The Tamil Nadu state public health department has started screening international passengers landing in the state of Tamil Nadu for symptoms of the Monkeypox virus as the first confirmed case of WHO South-East Asia Region has been reported in India after a traveler from Kerala who recently returned from the Middle East tested positive for the Monkeypox virus on 14 July 2022. The Tamil Nadu state government has increased the surveillance across the borders sharing with the state of Kerala and started screening at all international airports in Tamil Nadu. EPA-EFE/IDREES MOHAMMED

JOHANNESBURG, Aug 4 (Reuters) – 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 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.

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 did not immediately respond to an emailed request for comment. The company said at the time of the U.S. warning it was in discussions with regulators and the rate of reported cases of GBS in J&J 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 (J&J) 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 AZN.L 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)