South Africa’s health regulator on Thursday confirmed the first death of an individual causally linked to Johnson & Johnson’s (J&J) COVID-19 vaccine who developed Guillain-Barré syndrome after receiving the shot.
GBS is a rare neurological disorder in which the body’s immune system mistakenly attacks part of its peripheral nervous system — the network of nerves located outside of the brain and spinal cord — and can range from a very mild case with brief weakness to paralysis, leaving the person unable to breathe independently.
The person presented with symptoms shortly after vaccination, which led to prolonged hospitalization, mechanical ventilation, further infections and deaths, senior scientists said during a news conference.
“At the time of illness no other cause for the Guillain-Barre Syndrome could be identified,” said Professor Hannelie Meyer from the National Immunisation Safety Committee.
To protect patient confidentiality, Meyer said no patient details, including the province where the death occurred, will be made public.
In total 6,200 adverse reactions to COVID-19 vaccines have been reported the South African Health Products Regulatory Authority said on Thursday.
Helen Rees, chairperson of the South African Health Products Regulatory Authority (SAHPRA) board, said the country would not have seen such a rare side-effect if the vaccine had not been given to millions of people.
“We must be very careful to keep this event in proportion,” Rees said. “We must ask what is the risk of the disease itself?”
Rees said the death has been discussed with the World Health Organization and other regulators, who confirmed it was “very, very rare.”
SAHPRA’s chief, Dr. Boitumelo Semete-Makokotlela, said this was the first death confirmed to be linked to a COVID-19 vaccine.
Although the health agency has assessed the deaths of 160 people following COVID-19 vaccination in South Africa, those deaths were deemed “coincidental.”
SAHPRA statistics show that between May 17, 2021, and July 15, 2022, 217 deaths were reported following COVID-19 vaccination.
The U.S. Food and Drug Administration (FDA), in July of last year, added a warning to a factsheet for J&J’s vaccine — manufactured by Janssen — saying the shot had been linked to GBS, a “serious but rare” autoimmune disorder.
According to The New York Times, the chance of developing GBS after receiving the J&J shot at the time was three to five times higher than would be expected in the general population in the U.S.
U.S. authorities said data suggested an increased risk of GBS in the six weeks following vaccination, and acknowledged 100 suspected cases of GBS among recipients of the J&J shot through the Center for Disease Control and Prevention’s Vaccine Adverse Events Reporting System (VAERS) — a federal monitoring system that relies on patients and health care providers to report adverse effects of vaccines.
In a letter to the company, the FDA classified the chances of getting GBS after vaccination as being “very low.”
It advised J&J vaccine recipients to seek medical attention if they experience symptoms including weakness or tingling sensations, difficulty walking or difficulty with facial movements.
According to the most recent data from VAERS, between Dec. 14, 2020, and July 29, 2022, there has been a total of 2,850 reports of GBS, with 1,810 cases attributed to Pfizer, 525 cases to Moderna and 499 cases to J&J.
Of the 496 cases of GBS attributed to J&J’s COVID-19 vaccine, 11 cases resulted in death.
J&J’s COVID-19 vaccine is also linked to serious blood-clotting disorders.