The South African Health Products Regulatory Authority (SAHPRA) says one person has died after developing a rare condition associated with Johnson & Johnson’s COVID-19 vaccine.
The patient is reported to have developed Guillain-Barré syndrome, an extremely rare, but severe adverse event, associated with the administration of some medication and vaccines.
SAHPRA provides update on COVID-19 Vaccine Janssen – Guillain-Barré syndrome @nicd_sa @HealthZA@GCISMedia#SAHPRA#GBS#COVID19 #AEFIs#NDoH#AdverseEventsFollowingImmunisation#media#J&J#NISEChttps://t.co/GLg5822ghx
— SAHPRA (@SAHPRA1) August 4, 2022
The neurological disorder affects the body’s immune system and could cause paralysis.
SAHPRA says this is the first reported fatal case out of nine million J&J shots administered nationwide.
SAHPRA’s CEO Dr Boitumelo Semete- Makokotlela says, “The casualty assessment was conducted by NISEC and NISEC follows a very thorough methodology that is guided by WHO and utilized by all regulators across the world. In this assessment, there is a conclusion that this case of GBS was associated with the vents that the individual had received the COVID-19 vaccine”
In 2021, SAHPRA approved the pharmaceutical company Johnson and Johnson (J&J) vaccine booster doses for all healthcare workers who received the first shot as part of the Sisonke study.
This comes after the United States Food and Drug Administration (FDA) recommended a second dose of the J&J vaccine for all Americans aged 18 years and older who received a single dose.
Meanwhile, a new trial has since evaluated a booster dose given at least two months after the first dose in 31 300 participants from more than nine countries.
According to the data, vaccine efficacy against the disease was 94% in the United States and 75% globally.
In South Africa, 496 424 health workers received a dose of this vaccine to evaluate its effectiveness between February the 17th and May the 17th this year.
Linda-Gail Bekker gives update on vaccine rollout with Sisonke and J&J programme [ 10 May 2021]