Johnson & Johnson’s COVID vaccine linked to death in South Africa, health regulator reports

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 made in the country

The person developed the rare neurological disorder Guillain-Barre syndrome shortly after receiving J&J’s Janssen vaccine, after which he was put on a ventilator and later died, senior scientists said at a news conference.

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

The person’s age and other personal details were not disclosed for confidentiality reasons.

FDA WARNS OF POTENTIAL LINK OF JOHNSON AND JOHNSON’S COVID-19 VACCINE TO RARE DISORDER

J&J said in an emailed statement that GBS was associated with the administration of various vaccines and other medications and can also be caused by SARS-CoV-2, the virus that causes COVID-19.

The J&J vaccine has been coincidentally linked to a death for the first time in South Africa. Pictured: A health worker administers a dose of the coronavirus vaccine in Johannesburg, South Africa on 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 treated effectively.

Last July, US authorities added a warning to an information sheet for J&J’s vaccine saying data suggested there was an increased risk of GBS within six weeks of vaccination. At that time, it observed 100 preliminary reports of GBS in vaccine recipients, including 95 serious cases and one reported death.

J&J said at the time of the US warning that it was in discussions with regulators and that the rate of reported cases of GBS in recipients of the Janssen vaccine 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.”

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

WARNINGS FROM THE RIGHT AND THE LEFT ABOUT THE JOHNSON VACCINE LINK TO RARE DISEASES

Semete-Makokotlela said the regulator had assessed around 160 deaths since the rollout of the COVID vaccine began, but had so far seen no causal link to the vaccination.

South Africa has been using vaccines from J&J and Pfizer in its COVID vaccination campaign. The roll-out started slowly due to difficulties in securing supply and protracted negotiations with pharmaceutical companies, but more recently has been slowed by hesitation.

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