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FDA expected to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorde
Source: Washington Post
FDA expected to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder
The agency plans to cite a link to a small number of Guillain-Barré cases after vaccination but will say the shot’s benefits outweigh the risk
By Laurie McGinley and Lena H. Sun
July 12, 2021|Updated today at 2:05 p.m. EDT
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.
Most people fully recover, but some have permanent nerve damage, according to the CDC. People older than 50 are at greatest risk. In addition, about two-thirds of people who develop the syndrome experience symptoms several days or weeks after they have fallen ill with diarrhea or a lung or sinus illness.
Officials are expected to emphasize that the Johnson & Johnson vaccine is safe and that its benefits clearly outweigh the potential risks, according to the people familiar with the situation.
-snip-
The agency plans to cite a link to a small number of Guillain-Barré cases after vaccination but will say the shot’s benefits outweigh the risk
By Laurie McGinley and Lena H. Sun
July 12, 2021|Updated today at 2:05 p.m. EDT
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.
Most people fully recover, but some have permanent nerve damage, according to the CDC. People older than 50 are at greatest risk. In addition, about two-thirds of people who develop the syndrome experience symptoms several days or weeks after they have fallen ill with diarrhea or a lung or sinus illness.
Officials are expected to emphasize that the Johnson & Johnson vaccine is safe and that its benefits clearly outweigh the potential risks, according to the people familiar with the situation.
-snip-
Read more: https://www.washingtonpost.com/health/2021/07/12/johnson-and-johnson-warning/
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