Myocarditis and pericarditis after COVID-19 vaccine: risks and information for those who get vaccinated
The European Medicines Agency (EMA) has published thereport of thePharmacovigilanceRisk AssessmentCommitteewhich would seem to confirm the correlation between some rare cases ofmyocarditis and pericarditisand the administration of the anti-COVID vaccines ofPfizer-BioNTechandModerna. In the past, hypotheses had already been advanced about the correlation between the administration ofmRNA vaccinesand the occurrence of these cardiac inflammations as very rare cases. At the time, however, there was not yet sufficient data to be able to affirm the existence of a correlation. By virtue of what has been ascertained, now the EMA will order the modification of the “leaflet” of the two vaccines and the introduction of the necessary warnings.
mRNA vaccines: what link with myocarditis and pericarditis?
EMA has been carefully investigating a number of suspected cases of myocarditis and pericarditis following vaccination againstCOVID-19using theComirnaty (Pfizer-BioNTech) andSpikevax (Moderna) vaccines.
As of 31 May 2021, approximately 177 million doses of Comirnaty and 20 million doses of Spikevax had been administered in the European Economic Area. There were145reports regarding the occurrence ofmyocarditisin subjects who had been vaccinated with the Pfizer-BioNTech preparation. The subjects vaccinated with the Moderna vaccine who developed this inflammation were instead 19. Speaking instead ofpericarditisamong those vaccinated with the Pfizer-BioNTech vaccine, the reported cases were138, while among those who received the Moderna vaccine there were19 cases.
Most of these adverse reactions occurred within14 daysof administration of thesecond dose. Cardiac inflammation would affect male subjects more frequently, while there are already 5 deaths attributable to myocarditis, among people of advanced age or with concomitant diseases.
EMA sources then specified that inflammatory cardiac episodes attributable to mRNA vaccines have a course similar to that normally observed for myocarditis and pericarditis, with improvement with rest and pharmacological treatment.
Myocarditis and pericarditis: risk data with Janssen and Vaxzevria vaccines
At the end of May 2021, compared to 40 million doses administered of Vaxzevria vaccine and 2 million doses for Janssen vaccine, thereported cases of myocarditiswere: 38 for Vaxzevria and 0 for the Janssen COVID-19 vaccine.
Cases of pericarditiswere: 47 for Vaxzevria and 1 for the Janssen vaccine.
Pericarditis and myocarditis: indications for those who get vaccinated
According to the new provisions, those who undergo vaccination should be informed that very rare cases of myocarditis and pericarditis have occurred in people who have received Comirnaty (Pfizer) and Spikevax (formerly known as the Modern Vaccine).
Although the risk is very low, vaccinated people must know the symptoms associated with these heart inflammations, in order to be able to resort to medical treatment and avoid further complications.
If symptoms such as:
- wheezing or shortness of breath
- palpitations and/or a Strong heartbeat which may be irregular
- pain (acute and persistent) in the chest
the vaccinated must urgently seek medical attention.
US data reinforces correlation hypotheses
According to the ” Vaccine Adverse Events Reporting System ” published in the USA , the cases of myocarditis reported for every million second doses inoculated would have been between 39 and 47 in men and between 4 and 5in women. These data refer tothe 12-29 age grouptags. In the over 30s, the incidence of reports of heart inflammation was between4 and 5 for men and only 1 for women (data always calculated on a million doses administered).
All reports in the study date back to the time period prior to June 11, 2021.
However it’s good to remember that both EMA and the US authorities continue to recognize the validity of these mRNA vaccines in the fight against COVID-19. In particular, the EMA clarified through a note thatat the moment the benefits outweigh the risks .
The incidence of myocarditis in COVID patients
Myocarditis is already on the list of complications in people who get sick with COVID-19.
An Indian study conducted by researchers at Sampurnanand Medical College and published in the scientific journal ” The International Journal of Clinical Practice ” showed how much myocarditis affected predominantly male subjects.
In fact, 71.4%of those who develop this inflammation are men with an average age of 43.4 years. For women, the incidence is only29.6%tags. Of the 42 patients observed,57% (24 patients) developed feverish symptoms, while in the remaining cases symptoms of a different nature were observed.
Of the patients who developed severe fever, 8 died, while the remaining 16 recovered. The percentage of deaths is therefore equal to33% among individuals who developed fever, but drops to 19%if calculated on the total number of patients analysed. The percentage of those recovered was instead equal to67% of the total of those who had a high fever.
She defines herself as curious by nature. In 2006 she graduated with honors in Biotechnology at the Sapienza University of Rome. Between 2005 and 2009, she carried out a university internship and research activity in the field of tumor immunotherapy. She is a co-author of three scientific publications. Since 2007 you have associated your passion for science with that for the web, starting the management of the FitnessEquilibrium.com project.