The US FDA on Monday issued a letter to the company and classified the chances of getting Guillain-Barré syndrome (GBS) after vaccination as being “very low.” Still, J&J vaccine recipients should seek medical intervention if they have any kind of symptoms like weakness or tingling sensation, difficulty walking or difficulty with facial movements.
About 12.8 million people have received J&J’s one-dose vaccine in the United States so far. 100 preliminary reports of GBS in the vaccine recipients include 95 serious cases that required hospitalization and one reported death, informed FDA.
In a statement, J&J said that it was in discussion with regulators about the cases of GBS. The rate of reported cases of GBS in J&J vaccine receivers exceeds the background rate only by a small degree, it said.
GBS is a rare neurological condition in which the body’s immune system attacks the protective coating on nerve fibers. Most of the cases follow a bacterial or viral infection and most people completely recover from GBS.
The condition has been linked in the past to vaccinations that were the most notable vaccination campaign during a swine flu outbreak in the United States in 1976, and decades later to the vaccine used during the 2009 H1N1 flu pandemic.
According to a statement from the U.S. Centers for Disease Control and Prevention (CDC), most of the cases were recorded in men, many of whom were 50 or older. However, higher than expected cases of GBS in recipients of the mRNA-based vaccines from Pfizer Inc/BioNTech SE and Moderna Inc were not found in it.
European regulators earlier this week, suggested a similar warning for AstraZeneca’s COVID-19 shot, which is based on a similar technology as Johnson & Johnson’s vaccine.
The J&J shot which was supposed to be an important tool for vaccination is hard to reach areas and especially among those who are hesitant to be vaccinated because it requires only one shot and has less stringent storage requirements than the Pfizer or Moderna vaccines and this warning is another setback for the company.
But the use of the vaccine has already been linked to a very rare, potentially life-threatening blood clotting condition and slowed by production problems at the main plant where it is being made.
It was decided by the U.S regulators in April that the vaccine’s benefits overshadowed the risk from the blood clotting issue.
While the warning was first reported by the Washington Post on Monday.