United States regulators affixed a new word of caution on Monday to Johnson & Johnson's COVID-19 vaccine regarding links to a rare neurological reaction that has the likelihood to be dangerous. It remains to be unclear whether the dose resulted in the reaction. The Food and Drug Administration (FDA) made an announcement of the warning.
The consideration was due to a probable link between Guillain-Barre Syndrome and the vaccine. One hundred cases have been diagnosed in individuals who recently got vaccinated against COVID-19.
Is Guillain-Barre Syndrome the Cause of the Syndrome?
The FDA underscored an increase in reports of the paralyzing illness, even though the FDA stated it had not established Guillain-Barre syndrome as the cause of the syndrome. According to the federal agency, "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," reported ANI.
The FDA will affix the warning to Johnson & Johnson's emergency use authorization fact sheet. The decision arrives following the Centers for Disease Control and Prevention (CDC)'s recognition on Monday that their overseeing had detected a small probable susceptibility to this side effect.
Many of the 100 people who contracted the syndrome are 50 years old and beyond, reported CBS News.
A Blow for Johnson & Johnson
The reports are a blow for the company. It acquired an emergency use authorization for its vaccine in February. However, it has played a minor role in the coronavirus inoculation campaign of the United States. According to the peope informed regarding the matter, based on the evaluation of a federal vaccine safety monitoring system, officials have identified 100 preliminary reports of GBS following the administration of 12.5 million shots, reported Channel News Asia.
In the US, 2.8 million doses of the Johnson & Johnson coronavirus vaccine had been administered. The CDC coordinates with the FDA in overseeing vaccine safety systems. According to the FDA, of the reports of 100 people, 95 were in severe condition and required being admitted to the hospital. One individual was recorded as a fatalility.
According to health officials, the side effect is a small probable risk for individuals receiving the dose. Guillain-Barre syndrome emerges when the immune system of the body mistakenly attacks a number of its nerve cells. This results in paralysis at times, which is commonly temporary, and muscle weakness.
Guillain-Barre Syndrome is rare. However, it has the possibility to become severe.
The label states that news of adverse events upon use of the Janssen vaccine under emergency use authorization propose an increased risk of Guillain-Barre syndrome during the 42 days after inoculation. It is insufficient to establish a causal relationship despite the available evidence suggesting a connection between an increased risk of GBS and the Janssen vaccine.
Federal health officials think the benefits of J & J's vaccine remains to outweigh the susceptibilities. The word of caution adds another challenge to a formerly promising single-dose vaccine that faced remarkable scrutiny previously this 2021 over cases of blood clotting.
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