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U.S. Restricts Use of J&J's COVID Vaccine Due to Risk of Blood Clots

Charlie Brooks

May 06, 2022 09:38

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The US Food and Drug Administration said on Thursday that it will restrict adult use of Johnson & Johnson's (NYSE:JNJ) COVID-19 vaccination owing to the danger of a rare blood clotting condition, the latest setback for the injection that has been supplanted by competitors.


The J&J shot, which was cleared for adult use in the United States in February 2021, may be used in situations when permitted or approved COVID-19 vaccinations are unavailable or if an user is averse to receiving the other two doses, the Food and Drug Administration said.


J&J is one of three vaccinations that are now in use in the United States. The remaining two are from Moderna (NASDAQ:MRNA) and Pfizer, respectively (NYSE:PFE).


The vaccine manufacturer said that it has amended the COVID-19 vaccination information sheet for the United States to include a warning regarding the risk of thrombosis associated with thrombocytopenia syndrome (TTS), an uncommon but potentially fatal illness.


In high-income nations, use of the J&J shot has been limited, owing to reports of rare, possibly fatal blood clots, manufacturing difficulties, including an unintentional component mix-up by a contract manufacturer, and doubts about effectiveness.


The manufacturer revised its projection for COVID-19 vaccine sales last month, citing a supply glut.


TTS, which is characterized by blood clots and a low platelet count, has previously been documented in recipients of the J&J vaccination.


The FDA changed the information sheet for the J&J vaccine in January to reflect the risk of immune thrombocytopenia, after months of similar action by the European Union's medicines authority.


The FDA stated Thursday that after conducting a study into reported instances, the risk of TTS justified restricting the use of the single-dose injection.


In December, the US Centers for Disease Control and Prevention suggested that Americans take mRNA doses from Pfizer or Moderna rather than J&J's vaccination owing to the possibility of blood clotting.


According to the CDC, about 18.7 million Americans got a J&J COVID-19 injection, compared to 217.5 million who received the Moderna vaccination and 340.6 million who received the Pfizer shot.