The U.S. Food and Drug Administration (FDA) announced a new warning for the Johnson & Johnson (J&J) vaccine for the coronavirus disease 2019 (Covid-19) over its association with an increased risk of Guillain-Barre syndrome, a rare autoimmune disorder where the immune system damages the nerve cells.
The FDA announced the update to the one-shot jab on Monday in a letter to the company as well as in amendments to its fact sheet on the vaccine in response to new data showing cases of people displaying symptoms of the syndrome within 42 days of receiving the shot.
The warning states: “Reports of adverse events following use of Janssen Covid-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barre syndrome during the 42 days following vaccination.”
Janssen is a subsidiary of Johnson & Johnson.
The FDA said in its fact sheet for recipients and caregivers that “[t]he chance of having this occur is very low.”
Between 3,000 and 6,000 people develop Guillain-Barre syndrome each year in the United States with only about 100 people of the 12.8 million Johnson & Johnson dose recipients having shown symptoms, the FDA said. Of those who exhibited symptoms, 95 were hospitalized and there was one death.
The agency said that while there is enough evidence to suggest an association between the vaccine and the syndrome “it is insufficient to establish a casual relationship.”
The Centers for Disease Control and Prevention (CDC) said on its website Guillain-Barre syndrome is a rare disorder of the immune system attacking nerve cells, causing muscle weakness and sometimes paralysis and often follows infection of a virus or bacteria.
The CDC said men older than 50 were at greater risk of contracting the syndrome after receiving the shot.
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.