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 (NYSE: PFE) / BioNTech SE (NASDAQ: BNTX) and Moderna Inc (NASDAQ: 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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