South Africa’s Health Products Regulatory Authority (SAHPRA) has confirmed a second death from Guillain-Barre syndrome (GBS) following a Johnson & Johnson vaccine.

In a statement released on Monday, SAHPRA says a causality assessment of the case has been carried out by the National Expert Committee on Immunization Safety and the death has been classified as linked to the J&J vaccine.

The regulator urged the public to continue to report serious side effects after vaccination.

The first case of Guillain-Barré syndrome following the J&J vaccine was reported by SAHPRA in early August this year.

SAHPRA defines Guillain-Barre syndrome as a very rare but potentially serious drug-related neurological disorder.

The regulator has previously investigated reports of GBS linked to COVID-19 vaccines. They concluded that the J&J vaccine may increase the risk of GBS.

Despite this, SAHPRA argues that the benefits of the COVID-19 vaccine far outweigh the very low risk of severe disease.

Sisonke’s research

In 2021, SAHPRA approved booster doses of the vaccine from the pharmaceutical company Johnson and Johnson (J&J) for all healthcare workers who received the first vaccination as part of the Sisonke study.

This comes after the US Food and Drug Administration (FDA) recommended a second dose of the J&J vaccine for all Americans aged 18 and over who received one 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 data, the effectiveness of the vaccine against this disease was 94% in the United States and 75% worldwide.

In South Africa, 496,424 healthcare workers received a dose of this vaccine to evaluate its effectiveness between February 17 and May 17 this year.

Linda-Gail Becker provides an update on vaccine distribution with the Sisonke and J&J program [ 10 May 2021]

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