Posted on 05/23/2021 7:51:40 AM PDT by Cathi
Temporal_Relation_Between_Second_Dose_BNT162b2_mRN.pdf
file:///C:/Users/Owner/Downloads/Temporal_Relation_Between_Second_Dose_BNT162b2_mRN.pdf
This case highlights a potential relation between the second dose of a COVID-19 vaccine and mild cardiac involvement, compatible with acute myocarditis in an otherwise healthy patient with a previous exposure to SARS-COV-2 infection. Pharmacovigilance on cardiac injury is of paramount importance in this initial phase of massive COVID-19 campaigns with the aim to identify specific populations at increased risk and the target organs of adverse events. Even if no causal relationship can be demonstrated in this case report between the second dose of BNT162b2 mRNA COVID-19 vaccination and acute myocarditis, the timing of the onset and the inflammatory nature of the event make the relationship plausible. Of interest, among the 4 related serious events in the BNT162b2 vaccine trial, a paroxysmal ventricular arrhythmia was observed [5]. Ventricular arrhythmias can occur as consequence of an inflammatory cardiac injury [8, 9], and they were frequently observed in patients with COVID19 and cardiac injury [3]. Two deaths were documented during the trial and were judged as unrelated, although in one case a cardiac arrest occurred [5]. No reports of acute myocarditis were observed in the BNT162b2 mRNA and mRNA1273 trials. Acute myocarditis can be underestimated in clinical trials. Myocarditis must be actively searched as observed in anticancer agent studies involving immune checkpoints inhibitors [10, 11].
_______________________________
PRAC assessing reports of myocarditis with Comirnaty and COVID-19 Vaccine Moderna EMA is aware of cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) mainly reported following vaccination with Comirnaty. There is no indication at the moment that these cases are due to the vaccine. However, PRAC has requested the marketing authorisation holder to provide further detailed data, including an analysis of the events according to age and gender, in the context of the next pandemic summary safety report and will consider if any other regulatory action is needed. Additionally, the PRAC has requested the marketing authorisation holder for COVID-19 Vaccine Moderna β also an mRNA vaccine β to monitor similar cases with their vaccine and to also provide a detailed analysis of the events in the context of the next pandemic summary safety report. EMA will communicate further when new information becomes available.
_______________________________
Gretchen Bronson @gebronson Critical Care RN, Patient Advocate, 25yr Logistician & Policy Expert, Emergency Management/Response,
My unit has been seeing ~2-3 admits/week w/post pfizer/moderna myocarditis in young patients (<45) w/those <30 Upwards arrow critical Sx
Cardiologists & hospitalists who round are freaked out. As are the nurses.
Hospital system is now capturing data on anyone coming in post vaccination
π
see also ; 5/23/21 posting by FReeper Cathi at:
https://freerepublic.com/focus/f-chat/3961777/posts
(Title) : βThe BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and innate immune responses β
Exactly! Well said
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.