US FDA Issues Autoimmune Disease Warning After Janssen Vaccine Administration (Update)

[Asia Economy New York=Correspondent Baek Jong-min] The U.S. Food and Drug Administration (FDA) has issued a warning about a serious but rare autoimmune disorder linked to Johnson & Johnson subsidiary Janssen's COVID-19 vaccine. Following previous warnings about thrombosis, the Janssen vaccine is facing another alert, signaling potential red flags for future vaccinations.

According to U.S. media including CNN, the FDA and the Centers for Disease Control and Prevention (CDC) announced on the 12th (local time) that preliminary reports of 100 cases of Guillain-Barr? syndrome have been received among 12.8 million Janssen vaccine recipients in the U.S. Of these, 95 were severe enough to require hospitalization, and one person died.

[Image source=AP Yonhap News]

The majority of those affected are men aged 50 and older. Symptoms generally appeared about two weeks after vaccination, and most have fully recovered. The CDC plans to discuss the Guillain-Barr? syndrome issue related to the Janssen vaccine at an advisory committee meeting.

However, the FDA stated that "there is insufficient evidence to establish a definitive link between the Janssen vaccine and the syndrome." The U.S. government continues to emphasize daily that the risks of vaccination are significantly lower than not getting vaccinated, especially as vaccination rates have stalled around 70%.

Guillain-Barr? syndrome typically occurs following viral infections such as influenza. In the U.S., about 3,000 to 6,000 people are diagnosed annually, most of whom recover, though some may suffer permanent nerve damage. The CDC explains that Guillain-Barr? syndrome poses a higher risk for those aged 50 and above.

The Washington Post (WP) pointed out that this announcement could be another blow to the Janssen vaccine, which had the advantage of convenience with its single-dose regimen. Pfizer and Moderna vaccines require two doses but offer higher protection against the virus compared to Janssen.

The FDA had suspended the use of the Janssen vaccine in April due to the risk of thrombosis but resumed its use after adding a warning label about thrombosis risk for women under 50.

The U.S. is focusing on administering Pfizer and Moderna vaccines, with Janssen vaccinations progressing relatively slowly.

The U.S. has also donated Janssen vaccines nearing expiration overseas. In May, under the agreement from the Korea-U.S. summit, the U.S. supplied 1.01 million doses of the Janssen vaccine to South Korea. The U.S. also provided Janssen vaccines free of charge to Mexico.

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