Washington, Jul 12 (EFE).- The United States Food and Drug Administration (FDA) warned Monday that Johnson & Johnson’s coronavirus vaccine may lead to an increased risk of developing the rare neurological disorder, Guillain-Barré syndrome.
The decision comes after 100 preliminary reports of the syndrome were detected among the 12.8 million people who have received the one-dose Janssen vaccine in the US – that is, about 0.0008 percent of the total.
According to the FDA, 95 percent of cases were serious and the patients had to be hospitalized. One of them died.
The FDA has updated the Janssen vaccine information materials for recipients and physicians on its website.
“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 update reads.
However, it pointed out that “although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship.”
It also insisted that the benefits of receiving the Covid-19 vaccine outweigh the risks.
Johnson & Johnson said that it has held discussions with the FDA about this possible adverse effect and added that “the chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree.”
There is no data that shows a pattern of similar increased risk among those who received Moderna or Pfizer/BioNTech vaccines, which are made with a different technology and of which the US alone has already administered more than 321 million doses.
Guillain-Barré syndrome is a rare disorder in which the body’s immune system attacks the nerves, and can lead to pain, muscle weakness, difficulty walking and paralysis. Most people recover. EFE