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.
News Source : The Hindu
