Last Updated on October 15, 2024 by The Health Master
The US Food and Drug Administration (USFDA) yesterday amended the fact sheet for Johnson & Johnson’s C-19 vaccine to include a rare risk of immune thrombocytopenia, a bleeding disorder.
The regulator said in a letter to J&J‘s arm, Janssen Biotech Inc., that “reports of adverse events following use of the Janssen C-19 vaccine under Emergency Use Authorization (EUA) suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination,”
The symptoms include easy bruising or tiny blood spots under the skin, or unusual or excessive bleeding, the USFDA said.
The amendment fact sheet follows similar moves for the vaccine by other regulators, including that of the European Medicines Agency (EMA), in October.
Both the J&J and AstraZeneca vaccines, which are based on a similar platform, have previously been associated with another very rare combination of blood clotting and low platelet counts, known as thrombosis with thrombocytopenia syndrome.
The US Centers for Disease Control and Prevention also last month recommended Americans choose to receive one of two other authorized C-19 vaccines from Pfizer-BioNTech over J&J’s single-dose shot, due to the rare but sometimes fatal risk.
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