The South African Health Products Regulatory Authority (SAHPRA) on Thursday confirmed that a person died as a result of the COVID-19 vaccine.
SAHPRA’s chief executive officer, Dr. Boitumelo Semete-Makokotlela, said this was the country’s first death causally linked to an individual and Johnson & Johnson’s (J&J) COVID-19 vaccine.
To date, the health regulator assessed around 160 people who “possibly died” after getting the jab, but it had not seen a positive link to vaccination until now, Semete-Makokotlela said.
Soon after being given the J&J shot, the patient developed Guillain-Barré syndrome (GBS), a rare neurological disorder that has been identified as a possible side-effect of the jab.
“It is a very rare event,” said Hannelie Meyer, a professor of the national immunization safety committee, South African newspaper Daily Maverick reported. “The person presented with the symptoms shortly after vaccination and this had led to prolonged hospitalization, mechanical ventilation, and further infections.”
“At the time of illness no other cause for the Guillain-Barre syndrome could be identified,” she further declared.
GBS occurs when the immune system mistakenly attacks its own nerves, typically resulting in numbness, weakness, pain in the limbs, and sometimes even paralysis of breathing.
Meyer noted that the patient’s age and other personal details, including the province where the death occurred, will not be disclosed for confidentiality reasons.
Last year, the U.S. Food and Drug Administration (FDA) added a warning label to J&J’s COVID-19 vaccine, revising its fact sheets to “include information pertaining to an observed increased risk” of GBS following vaccination, a spokesperson for the agency told The Epoch Times on July 12, 2021.
That determination was made “based on an analysis of Vaccine Adverse Event Reporting (VAERS) data” which found “there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered,” the spokesperson said. At the time, 95 serious cases and one death were noted in the report of GBS cases in vaccine recipients.
According to the FDA, although available data suggest there is an association between the J&J vaccine and an increased risk of GBS, this is “insufficient to establish a causal relationship.”
A spokesperson for the U.S. Centers for Disease Control and Prevention told The Epoch Times that an “estimated 3,000 to 6,000 people” develop GBS every year in the United States, adding that the federal health agency is monitoring reports of GBS.
“It is typically triggered by a respiratory or gastrointestinal infection,” according to the spokesperson, who noted that “most people fully recover from GBS.”
Joe Phaahla, South Africa’s minister of health, said during a news conference on Thursday that as of mid-July, there had been more than 6,200 “adverse events” reported to SAHPRA out of the more than 37 million COVID-19 vaccine doses administered in the country, equivalent to 0.017 percent.
“The benefit of vaccination still far outweighs the risk,” said Semete-Makokotlela, after announcing a death had been positively linked to the shot.
Meanwhile, 217 deaths were reported to South Africa’s health regulator between May 2021 and July 2022 with claims that it was linked to the COVID-19 vaccine, Daily Maverick reported, citing SAHPRA statistics.
Of these cases, 33 remain under investigation, while about 150 others were reported as “coincidental” deaths. Two other people were found to have died due to complications of breakthrough infection after vaccination. In 30 other cases, the deaths could not be investigated properly due to a lack of information.
South Africa has been primarily using shots from J&J and Pfizer in its COVID-19 vaccination campaign, according to the federal government’s website. Around 32 percent of its population is now fully vaccinated.
Reuters contributed to this report.
