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EMA Finds Potential Blood Clot Link With JNJ COVID-19 Shot, Adds Safety Warning

EMA Finds Potential Blood Clot Link With JNJ COVID-19 Shot, Adds Safety Warning
  • The European Medicines Agency’s (EMA) safety committee said that the Johnson & Johnson’s (NYSE: JNJ) COVID-19 vaccine has possible links to rare blood clot incidents but reiterated, its benefits still outweighed the risk.
  • The agency did recommend the shot with an added warning regarding the rare but sometimes fatal blood clots with low blood platelets occurring within three weeks of vaccination.
  • Earlier this month, EMA started investigating the potential clotting risks from JNJ’s one-shot COVID-19 vaccine.
  • The committee reviewed all available evidence, including eight cases (with one being fatal) of the rare side effects among almost 8 million Americans vaccinated with the J&J vaccine.
  • The vaccine has yet to be administered in the EU.
  • The blood clots, which the committee said were “very similar” to clotting side effects linked to AstraZeneca’s Plc (NASDAQ: AZN) COVID-19 vaccine, occurred “mostly at unusual sites such as in veins in the brain (cerebral venous sinus thrombosis) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.”
  • As far as why the blood clots with low platelets are occurring, the EMA said one plausible explanation is an immune response leading to a condition similar to what can be seen sometimes in patients treated with heparin, called heparin-induced thrombocytopenia.
  • Meanwhile, earlier today, J&J reported $100 million in COVID-19 vaccine sales in the Q1 of 2021. 
  • Manufacturing issues at an Emergent BioSolutions Inc (NYSE: EBS) site in Baltimore also have raised questions about whether J&J, which has taken control of the facility, will produce enough vaccines for the US.
  • Emergent agreed not to initiate the manufacturing of any new material at its Bayview facility.
  • Earlier this month, EMA concluded that unusual blood clots should be listed as a “very rare side effect” of the Oxford/AstraZeneca COVID-19 vaccine.
  • Price Action: JNJ shares are up 2.87% at $167.36 in market trading hours on the last check Tuesday.

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Posted-In: Briefs COVID-19 VaccineBiotech Government News Health Care FDA General Best of Benzinga

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