The United States Food and Drug Administration (FDA) has added a new warning to the COVID-19 vaccine produced by Johnson & Johnson after receiving new reports that a very rare, but dangerous neurological reaction can occur.
With this, the South African Health Products Regulatory Authority (SAHPRA) has noted the recent findings but has said that it won’t stop the rollout of J&J jabs in South Africa.
The findings from the FDA report that a very tiny portion of the US population who received the single-dose J&J vaccine have developed what is known as Guillian-Barre syndrome.
Of the 12.5-million people who received the vaccine, 100 people were diagnosed with the immune system disorder. Most of those diagnosed were hospitalised, with one death recorded by the Centres for Disease Control and Prevent (CDC) amongst the 100.
New evidence linking Guillain-Barre syndrome and the J&J vaccine has been reviewed by the FDA and CDC, leading to the inclusion of the new health warning which will be added to pamphlets supplied to those about to get the jab, according to Business Insider.
A Very Rare Immunological Disease
Guillain-Barre syndrome is a rare immunological condition that affects one person in every 100,000 each year, according to the National Institute of Neurological Disorders and Stroke (NINDS). The disease causes the body’s immune system to attack the peripheral nervous system.
In mild cases, this attack on all the nerves outside of the brain and spinal cord, ie. nerves in arms and legs, can lead to weakness. In severe cases, the syndrome can lead to paralysis.
The exact cause of Guillain-Barre syndrome is unknown, but it is believed that this autoimmune response/attack is triggered by an infection with most cases occurring in people who have recently experienced a respiratory or gastrointestinal viral infection – both of which can be caused by COVID-19.
The syndrome’s mortality rate is 4% to 7%, with 30% of people still experiencing weakness after three years.
SAHPRA Says New Information Won’t Affect Rollout
“The Guillain-Barre syndrome is a well-characterised and rare adverse event of special interest for vaccines in general, which is being closely monitored,” said Yuven Gounden, Sahpra’s spokesperson, quoted by Business Insider.
“So far, there has not been a disproportionate increase in incidence to warrant a revision of risk-benefit of vaccines.”
“With the information available to SAHPRA to date, we do not foresee suspension,” said Gounden.
“However, we continue to assess the efficacy and safety of all vaccines.”
Of the 4,535,222 total vaccine doses administered in South Africa, 900,000 of them have been J&J jabs. Roughly half of these were dosed to healthcare workers during the Sisonke Programme.