Clinical FDA adds Guillain-Barre syndrome warning to Johnson & Johnson...

FDA adds Guillain-Barre syndrome warning to Johnson & Johnson Covid-19 vaccine


The US-based drug regulatory agency, FDA, has updated the label on coronavirus vaccine Johnson and Johnson to forewarn about the possible increasing risk of Guillain-Barre Syndrome (GBS), which is a rare neurological disorder.
The label reads, “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.”
The label further adds, “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.
Though FDA had not directly blamed the vaccine to be the cause of syndrome, it just had observed an increase in the reports of paralyzing conditions in the recipients of Janssen vaccine.
In a statement to CNN, it said, “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.”
Out of 12.8 million Janssen vaccine recipients in U.S., 100 preliminary cases of GBS had been reported in the government’s Vaccine Adverse Event Reporting System.
The FDA has recommended people facing any symptoms like weakness, tingling in arms and legs, difficulty in walking, speaking, chewing, double vision or bladder control problems after receiving a J&J vaccine, to immediately seek medical assistance.
Out of 100 reported cases, 95 cases needed hospitalization and one died, said FDA. “Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder,” it added.
Johnson and Johnson has confirmed its discussion with FDA and US Centers for Disease Control and Prevention regarding the issue. The company said, “We have been in discussions with the U.S. Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barré syndrome, that have been reported following vaccination with the Janssen COVID-19 vaccine.” It further added, “The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree.”
The FDA and CDC are monitoring cases of the syndrome. CDC has requested people to carry on vaccination of Coronavirus even if there is a chance of increased risk through this vaccine. Its spokesperson told CNN that CDC’s Advisory Committee on Immunization Practices would be discussing the matter in the meeting coming forth.
Dr, Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, also emphasized on getting vaccinated. “You’re always going to find some adverse event associated with vaccination,” Fauci told CNN’s Chris Cuomo.
It is yet another setback for J&J as the vaccine’s label was updated to warn about the risk. Previously, the use of this vaccine was paused earlier this year after having said that the vaccine caused blood clotting complications, but the pause was lifted by FDA and CDC in April after knowing that the risks were negligible and the condition was treatable.
After Pfizer’s and Moderna’s, J&J’s Janssen vaccine was the third one to win FDA’s emergency use authorization (EUA). According to the statistics of CDC, 84.6 million Americans are fully vaccinated with Pfizer’s vaccine, 62 million with Moderna’s and 12.7 million with J&J’s single-dose regimen.

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