The U.S. Food and Drug Administration is expected to issue a new warning for the COVID-19 vaccine from Johnson & Johnson, linking it to a rare autoimmune disorder, the Washington Post reported Monday.
The US Food and Drug Administration (FDA) is preparing to issue a new warning for a COVID-19 vaccine from Johnson & Johnson, linking it to a rare autoimmune disorder, the Washington Post reported Monday, citing four individuals familiar with the matter.
About 100 initial reports of Guillain-Barre syndrome — a disorder in which the immune system attacks nerves — have been discovered after 12.8 million doses of COVID-19, the US Centers for Disease Control and Prevention (CDC) said in a statement Monday. 19 jabs in the US.
Most cases of the rare disease have been reported in people aged 50 and over, usually two weeks after receiving the vaccination.
About 3,000 to 6,000 people in the United States develop Guillain-Barré syndrome each year. The disease, not fully understood, often follows a viral or bacterial infection.
The Washington Post reported that a slight increase in Guillain-Barré syndrome cases was associated with swine flu vaccines in the 1970s.
The new warning would be the latest blow to J&J’s COVID vaccine — which requires only one injection and can be stored more easily than the two-dose mRNA vaccines developed by Moderna and Pfizer/BioNTech.
In April, the Centers for Disease Control and Prevention and the Food and Drug Administration called for the use of J&J’s COVID-19 vaccine to be halted after it was linked to rare cases of severe blood clots, but they lifted the moratorium after determining that the vaccine’s benefits outweighed its risks.
J&J’s COVID-19 also experienced production problems earlier this year that led to 75 million doses of the vaccine being phased out.
Regulators in Europe also recommended a similar warning that the AstraZeneca COVID-19 vaccine may lead to an increased risk of Guillain-Barré syndrome.