The South African Health Products Regulatory Authority (SAHPRA) confirmed on Sept. 12, 2022 that another person in South Africa has died of a polio-like neurological disorder that causes paralysis known as Guillain-Barré syndrome (GBS) due to receiving Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S COVID-19 vaccine. SAHPRA said the National Immunization Safety Expert Committee (NISEC) performed a causality assessment of the case and classified the death as a vaccine product-related event.1 2
Guillian-Barre syndrome has been associated with vaccines, especially influenza vaccine, and reports of fatal cases of GBS during an influenza A “swine flu” mass vaccination campaign in the U.S. in 1976 effectively ended the campaign. Although some public health officials still question the causal link between GBS and flu shots, most researchers acknowledge there are studies demonstrating there is increased risk for developing GBS both after influenza infections and influenza vaccinations.3 4
According to SAHPRA’s chief executive Boitumelo Semete-Makokotlela, PhD, “The events reported in the vaccine recipient were consistent with the case definition of GBS, and no other likely cause of GBS was identified at the time of illness.” SAHPRA provided few other details of the case, citing “medical confidentiality.”2 5
“[GBS] can be mild but it can also lead to either rapid or progressive weakness and has the potential to affect the respiratory system,” said Marc Blockman, MBChB, MMED, professor of clinical pharmacology at the University of Cape Town and Groote Schuur Hospital. “It could be caused by bacterial or viral infections and certain medicines or vaccines could predispose patients to develop the syndrome. We were acutely aware of it and it was part of the vigilance plan.”6
This fatal case of GBS developing after J&J’s COVID vaccine is the second confirmed death in South Africa determined to have been caused by Ad26.COV2.S. It is one of about 160 deaths in the country that are possibly associated with the vaccine. The first death was reported by SAHPRA on Aug. 4, 2022 and in that case, the person developed GBS soon after the vaccination, was placed on a ventilator and subsequently died.6 7
South Africa Investigating Other Severe Adverse Events After COVID Vaccination
SAHPRA acknowledged that there have been other reported cases of adverse events following immunization (AEFI) in South Africa. The agency said, “Investigations and causality assessment of all reported severe AEFI with the COVID-19 Vaccine Janssen and other COVID-19 vaccines are ongoing. The outcomes of these investigations and causality assessments will be shared with the public as soon as they are completed.”1
FDA Warns of GBS Risk With J&J COVID Vaccine
The Ad26.COV2.S vaccine has also been associated with GBS in the United States. On July 12, 2021, the U.S. Food and Drug Administration (FDA) added a warning to the fact sheet for Ad26.COV2.S following reports of 100 cases of GBS among those who received the vaccine. Nine-five of those cases were apparently severe enough to require hospitalization, and one of those individuals died. According to the U.S. Centers for Disease Control and Prevention (CDC), most of the cases were “reported about two weeks after vaccination and mostly in males, many aged 50 years and older.”8 9 10
SAHPRA Offers Hotline for Reporting Adverse Events After Vaccination
SAHPRA is reportedly urging residents of South Africa to report any suspected adverse events following vaccination for COVID-19 or after the receipt of any pharmaceutical product. South Africans are encouraged to report to any health care facility or by calling a COVID hotline.5
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.Click here to view References:
1 Health-e News. Second J&J vaccine fatality recorded. Health-e News Sept. 12, 2022.
2 Rédaction Africanews with AFP. Two deaths in South Africa after Covid 19 vaccination. Africa News Sept. 14, 2022.
3 Fisher R. The fiasco of the “swine flu affair.” BBC Sept. 21, 2020.
4 Vellozzi C, Iqhad S, Broder K. Gullian-Barre Syndrome, Influenza and Influenza Vaccination: The Epidemiologic Evidence. Clin Infect Dis 2014; 58(8): 1149-1155.
5 Moonstone Information Refinery. Second GBS death linked to J&J’s Covid vaccine. Moonstone Sept. 15, 2022.
6 Ellis E. Health authorities confirm first vaccine-related death in South Africa. Daily Maverick Aug. 4, 2022.
7 Reuters. South Africa reports first death causally linked to COVID vaccine. Aug. 4, 2022.
8 Bugos C. Johnson & Johnson Vaccine to Include Warning About Guillain-Barré Syndrome. Verywell Health July 22, 2021.
9 Edwards E. FDA adds warning to J&J vaccine for possible link to rare neurological disorder. NBC News July 12, 2021.
10 U.S. Food and Drug Administration. Janssen COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers.