FDA to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder [View all]

[former9thward]

Source: Washington Post

The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect — Guillain-Barré syndrome, in which the immune system attacks the nerves, according to four individuals familiar with the situation.

About 100 preliminary reports of Guillain-Barré have been detected after 12.8 million doses of Johnson & Johnson vaccine were administered, the Centers for Disease Control and Prevention said in a statement. These cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older. Available data do not show a pattern suggesting a similar increased risk with the Pfizer-BioNTech and Moderna vaccines, after more than 321 million doses of those vaccines have been administered in the United States. The Guillain-Barré cases will be discussed as part of an upcoming meeting of CDC advisers, the agency said.

Guillain-Barré syndrome usually occurs at a rate of about 60 to 120 cases each week, according to CDC data. While the cause of the syndrome is not fully understood, it often follows infection with a virus, including influenza, or bacteria. Each year in the United States, an estimated 3,000 to 6,000 people develop the illness.

Read more: https://www.washingtonpost.com/health/2021/07/12/johnson-and-johnson-warning/?wpmk=1&wpisrc=al_news__alert-hse--alert-national&utm_source=alert&utm_medium=email&utm_campaign=wp_news_alert_revere&location=alert&pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJjb29raWVuYW1lIjoid3BfY3J0aWQiLCJpc3MiOiJDYXJ0YSIsImNvb2tpZXZhbHVlIjoiNTk2ZDViYWFhZGU0ZTIwN2QyOTZhYmVlIiwidGFnIjoid3BfbmV3c19hbGVydF9yZXZlcmUiLCJ1cmwiOiJodHRwczovL3d3dy53YXNoaW5ndG9ucG9zdC5jb20vaGVhbHRoLzIwMjEvMDcvMTIvam9obnNvbi1hbmQtam9obnNvbi13YXJuaW5nLz93cG1rPTEmd3Bpc3JjPWFsX25ld3NfX2FsZXJ0LWhzZS0tYWxlcnQtbmF0aW9uYWwmdXRtX3NvdXJjZT1hbGVydCZ1dG1fbWVkaXVtPWVtYWlsJnV0bV9jYW1wYWlnbj13cF9uZXdzX2FsZXJ0X3JldmVyZSZsb2NhdGlvbj1hbGVydCJ9.qTGCvc2H8GNOx--pYNX5S-ocTJmiGofQL2p7ZoWYqSs