FDA mandates warning of risk of blood clotting disorder with J&J COVID vaccine
Jon Cherry/Getty Images News


The FDA has ordered that a warning on the risk of immune thrombocytopenia ("ITP"), a blood clotting disorder, be added to the fact sheet given to healthcare providers that administer the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine.

ITP is a condition where the immune system mistakenly targets platelets that are needed for normal blood clotting, potentially leading to a dangerously low level of them.
Although rare, the warning states that the highest reporting rate (~1 case per 100,000 doses administered) is in females ages 30-49 years.
Both the J&J vaccine and the AstraZeneca (AZN
+0.3%) shot have come under scrutiny over potential links to ITP.

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