The South African Health Products Regulatory Authority (SAHPRA) has confirmed a second death from Guillain-Barre syndrome (GBS) following the Johnson & Johnson vaccine.
In a statement released on Monday, SAHPRA says, a causality assessment of the case was conducted by the National Immunisation Safety Expert Committee, and the death was classified as being related to the J&J vaccine.
SAHPRA releases latest update on COVID-19 Vaccine Janssen – 2nd case of Guillain-Barré syndrome @nicd_sa@HealthZA@GCISMedia#SAHPRA#GBS#COVID19 #AEFIs#NDoH#AdverseEventsFollowingImmunisation#media#NISEChttps://t.co/8JGeMPe3pu
— SAHPRA (@SAHPRA1) September 12, 2022
The regulator has urged the public to continue reporting severe adverse illness after vaccination.
SAHPRA defines Guillain-Barre syndrome as a very rare but potentially severely neurological event associated with the administration of medication.
The regulator had previously investigated reports of GBS associated with COVID-19 vaccines. They concluded that the J&J vaccine may increase the risk of GBS.
Despite this, SAHPRA says the benefits of the COVID-19 vaccine far outweighs the very low risk of severe illness.
Johnson & Johnson (JNJ.N) said on Monday it was in discussions with the US Food and Drug Administration about rare cases of a neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine.https://t.co/yPGXsDhpSD
— SABC News (@SABCNews) July 13, 2021
Sisonke study
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]
