EMA's Committee To Assess Further Data On Risk Of Heart Inflammation With mRNA COVID-19 Vaccines

EMA's safety committee is assessing further data on the risk of myocarditis and pericarditis after vaccination with COVID-19 shots from Pfizer Inc PFE / BioNTech SE BNTX and Moderna Inc MRNA.
Myocarditis and pericarditis are inflammatory conditions of the heart.
Related LInk: EMA Says Heart Inflammation Likely Linked To mRNA-Based COVID-19 Vaccines.
The committee has now asked the companies to perform an in-depth review of all published data on the association of myocarditis and pericarditis, including data from the clinical trial, literature, and public domain.
Additionally, the committee concluded that there is currently insufficient evidence on a possible link between COVID-19 vaccines and sporadic cases of multisystem inflammatory syndrome.
The assessment is based on the available spontaneous reports and currently does not warrant an update of the product information.
The PRAC has also started a review of a safety signal to assess capillary leak syndrome reports in people vaccinated with Moderna's COVID-19 vaccine.
Six cases of the syndrome, characterized by fluid leakage from blood vessels causing tissue swelling and drop in blood pressure, were reported in the EudraVigilance database.
PRAC said that it is not yet clear whether there is a causal association between vaccination and the reports of capillary leak syndrome.
Price Action: PFE stock is down 0.32% at $43.04, BNTX shares are down 0.66% at $282.10, and MRNA shares are down 0.87% at $344.89 during the premarket session on the last check Friday.

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