Janssen Vaccine Controversy Again... US FDA to Issue Autoimmune Disease Warning
Concerns Mount Again Following Warning on Thrombosis-Related Side Effects
[Asia Economy New York=Correspondent Baek Jong-min] The U.S. Food and Drug Administration (FDA) is reportedly planning to issue a warning about the association between Johnson & Johnson's subsidiary Janssen's COVID-19 vaccine and autoimmune diseases, according to the Washington Post (WP).
On the 12th (local time), WP cited sources saying that the FDA will warn about the possibility of Guillain-Barr? syndrome, an immune system disorder that attacks nerves, occurring due to the Janssen vaccine. The warning is expected to be issued as early as this week.
In this regard, the U.S. Centers for Disease Control and Prevention (CDC) also reported preliminary findings that Guillain-Barr? syndrome appeared in 100 people out of 12.8 million doses of the Janssen vaccine administered. Most of those who showed symptoms were men, and a significant number were aged 50 or older.
The CDC explained that although most cases of Guillain-Barr? syndrome recover fully, some may suffer permanent nerve damage, and the risk is higher in those aged 50 and above.
WP noted that a definitive conclusion on the link between the Janssen vaccine and Guillain-Barr? syndrome has not been reached, but the CDC advisory committee meeting will discuss the association between Guillain-Barr? syndrome and Janssen vaccine administration.
The Janssen vaccine, which had already seen a significant decline in use in the U.S. due to the possibility of causing thrombosis, now faces further potential setbacks with the raised possibility of association with Guillain-Barr? syndrome.
An aircraft carrying Janssen vaccines donated by the U.S. government arrived at a Mexican airport.
[Image source=EPA Yonhap News]
In April, the FDA had suspended the use of the Janssen vaccine due to the risk of thrombosis, then resumed vaccinations after adding a warning label about thrombosis for women under 50, but it remains less preferred compared to Pfizer or Moderna vaccines.
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The Janssen vaccine, which requires only a single dose, is being offered free of charge to tourists in many U.S. municipalities including New York City. The U.S. government also donated 1 million doses of the Janssen vaccine nearing expiration to South Korea. The U.S. has also provided Janssen vaccines to Mexico.
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