The U.S. FDA is expected to issue a new warning for Johnson & Johnson’s COVID-19 vaccine, linking it to a rare autoimmune disorder, the Washington Post reported Monday.
The U.S. Food and Drug Administration (FDA) is preparing to issue a new warning for Johnson & Johnson’s COVID-19 vaccine, linking it to a rare autoimmune disorder, the Washington Post reported Monday. which cites four people familiar with the matter.
The U.S. Centers for Disease Control and Prevention (CDC) said Monday in a statement that about 100 preliminary reports of Guillain-Barre syndrome have been detected, a disorder in which the immune system attacks the nerves, after of 12.8 million doses of J&J COVID. 19 times in the US.
Most cases of rare disease were reported in people 50 years of age or older, usually two weeks after receiving the vaccination.
In the US, between 3,000 and 6,000 people develop Guillain-Barre syndrome each year. The disease, which is not fully understood, often follows a viral or bacterial infection.
An increase in Guillain-Barre syndrome cases was related to swine flu vaccinations in the 1970s, the Washington Post reported.
A new warning would be the latest hit from J&J’s COVID vaccine, which only requires a punch and can be stored more easily than the two-dose mRNA vaccines developed by Moderna and Pfizer / BioNTech.
In April, the CDC and the FDA called for a pause in the use of J&J’s COVID-19 vaccine after linking it to rare cases of severe blood clots, but lifted the temporary stop after determining that the benefits of the vaccine outweighed its risks.
J&J’s COVID-19 jab also suffered production problems earlier this year that resulted in the release of 75 million doses of the vaccine.
European regulators have also recommended a similar warning that AstraZeneca’s COVID-19 vaccine could increase the risk of Guillain-Barre syndrome.