Johnson & Johnson’s Covid-19 vaccine could cause paralysis, warns FDA
In a major setback to the efforts to immunise people against the deadly Covid-19 virus, the US Food and Drug Administration (FDA) on Monday issued a warning stating that the Johnson & Johnson coronavirus vaccine could cause rare neurological complications in some cases.
While the FDA stated that it wasn’t established yet whether the vaccine could cause the condition, it observed an increase in reports of the sometimes paralysing condition called the Guillain-Barre syndrome.
“Today, 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-Barre Syndrome (GBS) following vaccination,” the FDA said in a statement, according to CNN.
While the J&J vaccine has run into trouble, the FDA informed that the Moderna and Pfizer-BioNTech Covid-19 vaccines do not show any such issue.
“Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of Guillain-Barre syndrome during the 42 days following vaccination. 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,” it said.
The US drug regulator further said that out of the 12.8 million Janssen vaccines administered, as many as 100 preliminary reports of GBS had been registered with the US Vaccine Adverse Reporting System.
“Guillain Barre 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 said in its label update.
It said that people should immediately seek medical attention if symptoms such as weakness or tingling in the arms and legs arise, especially if it spreads.
Other symptoms doing the rounds include difficulty in walking, speaking, chewing or swallowing; double vision; and bowel or bladder control problems.
The United States Centers for Disease Control and the FDA had briefly put a pause on the use of the J&J vaccine earlier this year after a rare type of blood clotting complication arose in some cases but lifted the embargo in April after confirming that the risks were low and it was treatable.