FDA adds new warning to J&J jab – but it won't impact SA's rollout

Business Insider SA
J&J vaccine South Africa
(Photo by Matthias Bein/picture alliance via Getty Images)
  • The US Food and Drug Administration has added a new warning to the Johnson & Johnson's Covid-19 vaccine.
  • This comes after 100 people – out of 12.5 million vaccinated with the vaccine – developed Guillain-Barre syndrome.
  • The potentially life-threatening autoimmune disorder attacks the body's peripheral nervous system and can lead to weakness, in mild cases, and paralysis, in severe cases.
  • But unlike the previous red flag raised by the FDA on blood clots, the Johnson & Johnson vaccine will continue to be rolled out.
  • South Africa's drug regulator says its aware of the new warning but that won't lead to a suspension of jabs like the FDA's findings in April did.
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The United States' Food and Drug Administration (FDA) has added a new warning to the Covid-19 vaccine produced by Johnson & Johnson after receiving reports of a rare but dangerous neurological reaction. The South African Health Products Regulatory Authority (Sahpra) has noted the recent finding but says it won't stop the rollout of J&J jabs.

A tiny portion of the US population who received the single-dose J&J vaccine have developed Guillain-Barre syndrome. Of the 12.5 million people who received the J&J jab, 100 people were diagnosed with the immune system disorder, with most being hospitalised and one death recorded by the Centres for Disease Control and Prevention (CDC).

Evidence which links Guillain-Barre syndrome and the J&J vaccine has been reviewed by the FDA and CDC, prompting the inclusion of a new health warning which will be added to pamphlets supplied to those getting the jab, according to Associated Press.

Guillain-Barre syndrome is a rare condition – affecting one person in 100,000 each year, according to the National Institute of Neurological Disorders and Stroke (NINDS) – which causes the body's immune system to attack the peripheral nervous system. This attack on the network of nerves outside of the brain and spinal cord can lead to weakness, in mild cases, and body paralyses, in severe cases.

The exact cause of Guillain-Barre syndrome is not known but it's understood that this autoimmune attack is triggered in response to an infection. Most cases develop in people who have recently experienced a respiratory or gastrointestinal viral infection, according to the NINDS. The syndrome's mortality rate is 4% to 7%, with 30% of people still experiencing weakness after three years.

And while the potentially life-threatening condition has raised enough of a concern to be listed by the FDA, South Africa's regulator says although it's monitoring the situation, it has no intention of scrapping the use of J&J jabs.

"The Guillain-Barre syndrome is a well-characterised and rare adverse event of special interest for vaccines in general, which is being closely monitored," Yuven Gounden, Sahpra's spokesperson, explained to Business Insider South Africa on Tuesday.

"So far, there has not been a disproportionate increase in incidence to warrant a revision of risk-benefit of vaccines."

Sahpra, which authorises vaccines for use in South Africa, previously followed the FDA's lead when the J&J rollout was temporarily suspended due to isolated reports of rare blood clotting in the US. But this situation with warnings about Guillain-Barre syndrome is not the same as the red flags raised in April, said Gounden.

"Blood-clotting events with vaccines were a new and unknown effect associated with new vaccine platforms, as such, a pause was necessary to re-evaluate the risk benefit of these vaccines."

Unlike the pause because of blood clots, the FDA has not advised against the use of J&J jabs. Sahpra agrees and has no intention of suspending the vaccine's use in South Africa.

"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."

South Africa has, to date, administered more than 900,000 doses of the J&J vaccine – roughly half of these targeting healthcare workers during the Sisonke Programme – and relies on the jab to underpin the vaccination of essential workers. Aspen's production facility in Gqebera is expected to deliver around 9.5 million J&J does by the end of September. 

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