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FDA lists rare neurological condition as potential side effect of J&J’s COVID-19 vaccine

Guillain-Barré syndrome has been reported in 100 people who have received the vaccine in the US

The US Food and Drug Administration (FDA) has added the rare neurological condition Guillain-Barré syndrome as a potential side effect of the Johnson & Johnson COVID-19 vaccine.

On Monday, The Washington Post reported that FDA had warned there is data ‘connecting the [vaccine] to an increased risk’ of Guillain-Barré syndrome, which occurs when the immune system begins to attack nerves in the body.

In an amendment to the fact sheet for the vaccine, the FDA has now included the following information: “Guillain Barré syndrome […] has occurred in some people who have received the Janssen COVID-19 vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low.”

According to The New York Times, there have been 100 reports of the syndrome in people who have received the J&J vaccine, out of nearly 13 million individuals in the US who have received the jab.

Of those reported cases, 95 resulted in hospitalisation and one was fatal, with the syndrome primarily reported in men. Many of the reported cases occurred in people aged 50 years and over, officials added.

Although there is not yet enough evidence to clearly link the vaccine to the condition, the FDA said it is continuing the monitor the situation.

In its own statement,  J&J said: “Any adverse event report about individuals receiving Johnson & Johnson’s single-shot COVID-19 vaccine, as well as our own assessment of the report, is shared with the US Food and Drug Administration, the European Medicines Agency, the World Health Organization and other health authorities around the world where our vaccine is authorised.

“We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated.”

Earlier this year, rollout of the J&J COVID-19 vaccine was paused following reports of a rare and severe type of blood clot – known as cerebral venous sinus thrombosis (CVST) – observed in individuals after receiving the single-dose jab.

In these cases, the rare blood clots were seen in combination with low levels of blood platelets, known as thrombocytopenia.

According to the US Centers for Disease Control and Prevention (CDC) and FDA, nearly all reports of these events were observed in adult women younger than 50 years old.

Following a review of the cases, the temporary pause was lifted after regulators concluded that the vaccine’s benefits outweigh its risks, although they added that women under the aged of 50 should be aware of the rare but increased risk of very rare blood clots with low platelets.

Article by
Lucy Parsons

13th July 2021

From: Regulatory



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