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The South African health authority on Thursday reported 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 established in the country.
The person presented with a rare Guillain-Barre neurological syndrome soon after receiving J&J’s Janssen vaccine, after which the person was put on a ventilator and later died, senior scientists said at a news conference.
‘No other cause for Guillain-Barre syndrome (GBS) could be identified at the time of the disease,’ said Professor Hannelie Meyer.
The person’s age and other personal data were not disclosed for confidentiality reasons.
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J&J said in an e-mailed statement that GBS has been associated with the administration of various vaccines and other medicines and may also be activated by SARS-CoV-2, the virus that causes COVID-19.
The company said it strongly supports awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.
Last July, US authorities added a warning to a J&J vaccine fact sheet saying the data suggested there was an increased risk of GBS in the six weeks following vaccination. At the time, it found 100 preliminary reports of GBS in vaccinated patients, including 95 serious cases and one reported death.
J&J said it was in discussion with regulators at the time of the U.S. warning and the reported rate of GBS in patients who had received the Janssen vaccine 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 vaccine, and this is the first causally linked case of GBS.”
The European medicines regulatory authority 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 a press conference on Thursday that in mid-July there had been just over 6,200 “adverse events” reported to SAHPRA of the more than 37 million doses of COVID vaccine administered in the country, or 0.017%. .
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Semete-Makokotlela said the regulator has estimated around 160 deaths since the introduction of COVID vaccination began, but had not seen a causal link with the vaccination until now.
South Africa used shots from J&J and Pfizer in its COVID vaccination campaign. The launch started slowly due to difficulties in securing supplies and lengthy negotiations with pharmaceutical companies, but has more recently been slowed by hesitation.
About 46% of its 40 million adult population is now fully vaccinated.