EMA Says Heart Inflammation Likely Linked To mRNA-Based COVID-19 Vaccines

  • European Medicines Agency (EMA) has established a probable link between heart inflammation and mRNA-based COVID-19 vaccines made by Pfizer Inc PFE and Moderna Inc MRNA.
  • The EMA said that heart conditions myocarditis and pericarditis must be listed as possible side effects of the two mRNA vaccines.
  • This included an in-depth review of 145 cases of myocarditis and 138 cases of pericarditis in Europe among people who received BioNTech SE's BNTX Comirnaty and 19 cases in those who received Moderna's Spikevax.
  • No causal relationship with myocarditis or pericarditis could be established with Johnson & Johnson JNJ and AstraZeneca's Plc AZN COVID-19 shots.
  • The committee has requested additional data from the companies marketing these vaccines.
  • The EMA panel has also advised that people with a history of capillary leak syndrome should avoid Johnson & Johnson's single-shot coronavirus vaccine.
  • Three cases of capillary leak syndrome (CLS) were reviewed who had received a J&J shot. One of those affected had a history of CLS, and two of them subsequently died.
  • A couple of weeks back, the FDA added a warning to patient and provider fact sheets for the Pfizer and Moderna COVID-19 vaccines to indicate a rare risk of heart inflammation.
  • Price Action: PFE stock +1.03% at $39.65, BNTX shares are +4.05% at $216.35, AZN stock +1% at $59.85 and JNJ stock +0.4% at $169.77, while MRNA stock -0.15% at $232.45 during the market session on the last check Friday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 Vaccineinflammatory diseases
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