Myocarditis and Pericarditis following mRNA COVID-19 Vaccines
Professor Saad Shakir
During the first 18 months of the pandemic, pharmacovigilance focussed on the immediate urgent tasks for assessing the benefit/risks (B/R) of vaccines and treatments for COVID-19 with the available (limited) data at the time. The world was lucky that COVID-19 vaccines and treatments were mostly effective with few very rare short term adverse drug reactions (ADRs). The main advantages of both vaccines and treatments were that they reduced serious morbidity and mortality for COVID-19 significantly with an acceptable (B/R) balance.
Like other communicable diseases COVID-19 (with its successive variants) will not go. Therefore, pharmacovigilance has moved to a different phase. Pharmacovigilance now is trying to improve our understanding (compared to the original urgent evaluations) of the nature, risk factors, preventability, frequency and other characteristics of serious ADRs.
Further studies and reviews facilitate better understanding of the ADRs and B/R balance of the COVID-19 vaccines and treatment. This will allow better public health decisions, clinical management and direct better research.
The DSRU has conducted a systematic review of spontaneous reports in the UK, EU and the US (included 18,204 reports) and 32 observational studies. The results of the studies were consistent with the spontaneous reports. Both are in line with the earlier findings, that younger vaccinees more frequently reported myocarditis and pericarditis following mRNA COVID-19 vaccines than older vaccinees. The majority were young men below the age of 40 years who had the ADRs after the second jab. The frequency of these events is yet to be determined accurately.
However, some questions remain unanswered. People are keen to know is whether the COVID-19 vaccines are associated with long-term effects or whether all serious ADRs people who develop more serious ideas with vaccines are reversible totally of partly.
The full text of this systematic review has been published in BMJ Open and is available here.
The contents of this article have not been peer-reviewed; it should not replace individual clinical judgement, and the sources cited should be checked. The views expressed in this commentary represent the views of the authors. These views are not a substitute for professional medical advice.