Janssen Vaccine Controversy Again... US FDA Issues Autoimmune Disease Warning (Comprehensive)

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[Asia Economy New York=Correspondent Baek Jong-min] The U.S. Food and Drug Administration (FDA) has issued a warning about the association between autoimmune diseases and the COVID-19 vaccine from Janssen, a subsidiary of Johnson & Johnson (J&J).

On the 12th (local time), the FDA and the U.S. Centers for Disease Control and Prevention (CDC) announced that preliminary reports indicated 100 cases of Guillain-Barr? syndrome among 12.8 million Janssen vaccine recipients in the United States. Among these, 95 individuals experienced severe symptoms requiring hospitalization, and one person died. Neither agency provided specific details regarding the cause of death.

Most of the affected individuals were men aged 50 and older, who generally reported symptoms about two weeks after vaccination, with most reportedly recovering fully. The CDC plans to discuss the Guillain-Barr? syndrome issue at an upcoming advisory committee meeting. However, despite this evidence, the FDA added that "there is insufficient evidence to establish a definitive link between the Janssen vaccine and the syndrome."

The exact cause of Guillain-Barr? syndrome is not fully understood, but it typically appears following viral infections such as influenza. In the United States, it usually affects between 3,000 and 6,000 people annually. While most patients recover completely, some may suffer permanent nerve damage, and the CDC explains that individuals aged 50 and older are at higher risk.

The Janssen vaccine had already seen a significant decline in use in the U.S. due to concerns about blood clot risks, and the newly raised possibility of an association with Guillain-Barr? syndrome may deal another blow. The Washington Post (WP) pointed out that this announcement could be another setback for the Janssen vaccine, which had the advantage of requiring only a single dose. In contrast, Pfizer and Moderna vaccines require two doses.

In April, the FDA had paused the use of the Janssen vaccine due to blood clot risks but resumed vaccinations after adding a warning label about blood clots for women under 50. However, it remains less preferred compared to Pfizer or Moderna vaccines. The FDA has repeatedly emphasized that the benefits of vaccination with Janssen far outweigh the potential risks.

In the U.S., many areas including New York City offer the Janssen vaccine free of charge to tourists. The U.S. government also donated 1.01 million doses of the Janssen vaccine nearing expiration to South Korea. Additionally, the U.S. provided Janssen vaccines to Mexico.

This content was produced with the assistance of AI translation services.