The US Food and Drug Administration updated the label on Johnson & Johnson’s coronavirus vaccine Monday to warn of the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome.
On Monday, the U.S. Food and Drug Administration announced a new warning of the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome for the Johnson & Johnson COVID-19 vaccine.
The FDA updated the label on Monday in a letter to the Janssen Biotech, Inc. as well as in amendments to its fact sheets on the Johnson & Johnson’s coronavirus vaccine in response to new data showing cases of people displaying symptoms of the syndrome within 42 days of receiving the shot.
“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination,” the updated label reads.
The FDA said in its fact sheet for recipients and caregivers that “[t]he chance of having this occur is very low.”
The FDA said 100 preliminary reports of Guillain-Barré syndrome had been filed with the US government’s Vaccine Adverse Reporting System, out of 12.8 million Janssen vaccines given.
“Guillain Barré syndrome (a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine,” the FDA says in the label update for patients and caregivers.
People should seek medical attention if they notice symptoms such as weakness or tingling in the arms and legs, especially if it spreads, after receiving a vaccine, the FDA said.
Johnson & Johnson released a statement Monday stating it has updated its COVID-19 vaccine factsheet to include the new warning while reiterating that evidence continues to prove its vaccine protects against the coronavirus.
“Evidence has demonstrated that Johnson & Johnson’s single-shot COVID-19 vaccine offers protection against COVID-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent,” it said.
The FDA gave the Johnson & Johnson jab emergency use approval in late February.
In April, CDC issued a warning for the vaccine concerning its association with a rare blood clotting disease, ending a federal government temporary halt to the drug’s distribution.
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