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USFDA warns against rare bleeding risk of JnJ COVID vaccine
![USFDA warns against rare bleeding risk of JnJ COVID vaccine USFDA warns against rare bleeding risk of JnJ COVID vaccine](https://medicaldialogues.in/h-upload/2020/09/07/750x450_134179-johnson2.webp)
New Delhi: The U.S. Food and Drug Administration on Tuesday amended the fact sheet for Johnson & Johnson's COVID-19 vaccine to include a rare risk of immune thrombocytopenia, a bleeding disorder.
"Reports of adverse events following use of the Janssen COVID-19 vaccine under emergency use authorization suggest an increased risk of immune thrombocytopenia during the 42 days following vaccination," the regulator said in a letter to J&J's arm, Janssen Biotech Inc.
The symptoms include easy bruising or tiny blood spots under the skin, or unusual or excessive bleeding, the FDA said.
The amendment fact sheet follows similar moves for the vaccine by other regulators, including that of European Medicines Agency in October.
Read also: Janssen Pharma seeks USFDA nod for Teclistamab to treat multiple myeloma
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 U.S. Centers for Disease Control and Prevention had also last month recommended Americans choose to receive one of two other authorized COVID-19 vaccines from Pfizer-BioNTech, over J&J's single-dose shot, due to the rare but sometimes fatal risk
Read also: J&J says its single dose protects against breakthrough COVID-19 for up to 6 months
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751