FDA Attaches Warning to Johnson & Johnson Vaccine

Source: Reuters

FDA issued a warning for Johnsons & Johnson’s vaccine after reports of a rare neurological complication called Guillain-Barre syndrome come forward.

The Johnson & Johnson COVID-19 vaccine has once again made headlines for causing a rare side-effect. Since its approval in March, the vaccine has raised multiple concerns among recipients and researchers alike. Previously the vaccine was linked to causing severe, painful rash and even blood clots in recipients. The cases of blood clots had even led to a temporary halt of the vaccine within the United States. Now, the US Food and Drug Administration (FDA) has issued another warning for the COVID-19 vaccine amid reports of a rare neurological complication.

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-Barré Syndrome (GBS) following vaccination.

The US Food and Drug Administration

In a statement released on Monday, the FDA reported that it was attaching another warning label to the Johnson & Johnson vaccine. This time for the increased risk of a rare autoimmune disorder, Guillain-Barré Syndrome (GBS). According to FDA’s fact sheet, the symptoms usually begin during the 42 days after vaccination. However, the officials added that current data is insufficient for establishing a causal relation between GBS and the vaccine.

More than 12 million people in the US have received the single-dose vaccine. Out of these approximately 100 developed GBS. Most of these cases occurred in men over 50 years of age. Furthermore, only one recipient has died from the disorder. However, the 57-year-old had suffered a heart attack and stroke within the last four years; thus, causing doctors to question the cause of his death.

What is Guillain-Barré Syndrome?

Guillain-Barré Syndrome (GBS) is a rare neurological disorder brought on by the body attacking its own nerves. Thus, resulting in muscle weakness, tingling sensation in extremities, difficulty chewing, inability to walk, and bowel/bladder problems. Often the disease can progress to cardiac arrhythmias, respiratory distress, and eventually death. However, most people recover fully with adequate supportive care and plasmapheresis.

Although the exact cause is unknown, GBS can occur after viral infections such as with the Zika virus and even SARS-C0V-2.

We have been in discussions with the US Food and Drug Administration and other regulators about rare cases of the neurological disorder, Guillain-Barré syndrome, that has been reported following vaccination with the Janssen Covid-19 vaccine. The chance of having this occur is very low, and the rate of reported cases exceeds the background rate by a small degree.

Johnson & Johnson Company

Although the risk of developing the disorder is low, health officials argue that it is three to five times higher among J&J vaccine recipients than the general population. However, some researchers argue that the vaccine’s benefits outweigh the potential risk. Moreover, they believe FDA’s warning will likely further decrease the vaccination rates in the country.

Source: The US Food and Drug Administration


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