FDA Updates J&J COVID-19 Vaccine Label to Include Rare Disorder

FDA recently updated the label on Johnson & Johnson’s COVID-19 vaccine to warn of the possible side effect of Guillain-Barre syndrome, according to multiple news outlets. 

Of the 100 cases of Guillain-Barre Syndrome reported among Johnson & Johnson vaccine recipients, about 95 percent of these cases were deemed serious and required hospitalization. 

Although the chances of developing the neurological disorder are low, they are three to five times higher among recipients of the vaccine than among the general population in the US, experts said. 

"The FDA is announcing revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination," the agency said in a statement to CNN.

Guillain-Barre syndrome is a rare disorder in which the body's immune system attacks the nerves. 

FDA stated that individuals who are experiencing symptoms, including weakness or tingling in the arms and legs, difficulty walking, or difficulty with facial movements, should seek immediate medical attention. 

Most symptoms begin within 42 days following the single-shot Johnson & Johnson vaccine.

To date, nearly 12.8 million people have received the Johnson & Johnson vaccine while 146 million have been fully vaccinated with the Pfizer or Moderna vaccines.

Although there is no evidence of increased risk of Guillain-Barre syndrome in individuals who received the Pfizer or Moderna vaccines, some experts believe that the newly developed side effect for the Johnson & Johnson vaccine could increase vaccine hesitancy.

"Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship. No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines,” FDA stated in the updated label.

In a statement released following FDA’s updated label change, Johnson & Johnson said that the safety and well-being of the people who use its products is the company’s number one priority. 
“While the chance of having this occur is very low, Johnson & Johnson has updated its COVID-19 Vaccine Factsheet to include important information about these rare cases and on the signs and symptoms of Guillain-Barré syndrome. Updates with this new information will be implemented in other regions of the world according to local regulatory procedures,” the company said in the statement.