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Coronavirus Update: EMA To Update Comirnaty And Spikevax Labels On Cardiac Safety

Plus, New REGEN-COV Filing And Novel Vaccine Progress

 
• By Scrip Team

Comirnaty and Spikevax to get EU label update on cardiac safety, Japanese filing for REGEN-COV, plus vaccine progress for ReiThera and Genexine.  

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EU regulators add cardiac safety statements for mRNA vaccines • Source: Alamy

The European Medicines Agency is to join the US Food and Drug Administration in adding details of rare cardiac adverse events associated to the product information of two mRNA-based vaccines for COVID-19.

The EMA’s safety committee (PRAC) has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with Pfizer Inc./BioNTech SE's Comirnaty and Moderna, Inc.’s...

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