The European Medicines Agency (EMA) reported that the Pfizer and Moderna vaccines may be associated with rare cases of inflammation in the heart, after analyzing 321 cases of those vaccinated against SARS-CoV-2.
Myocarditis and pericarditis are inflammatory heart diseases that present with symptoms such as shortness of breath, heart palpitations, and chest pain.
The Pharmacovigilance Risk Assessment Committee (PRAC) studied 145 cases of myocarditis and 138 cases of pericarditis, after being vaccinated with Pfizer, after analyzing only 19 cases of each inflammation, among those vaccinated with Moderna.
By the end of May, approximately 177 million doses of the Pfizer vaccine and 20 million doses of Moderna had been administered in the European Economic Area (EEA).
PRAC advised updating vaccine information to include side effects and to raise awareness among health teams and users.
a The committee also recommended limiting marketing of the Johnson & Johnson vaccine to people with a history of capillary leak syndromeClarkson’s disease.
According to PRAC, it is advised to add a warning for Clarkson’s disease, in which fluid leaks into small blood vessels causing swelling, low blood pressure, thickening of the blood, and low levels of blood albumin.
PRAC added that the product information used In AstraZeneca it includes a warning to raise awareness about cases of Guillain-Barré (SBG) syndrome, which may have been reported after vaccination.
The syndrome causes inflammation of the nerves and can lead to pain, numbness, muscle weakness, and difficulty walking.
In June, the US Centers for Disease Control and Prevention (CDC) announced that heart inflammation in adolescents and young adults could be linked to the Pfizer and Moderne vaccines against SARS-CoV-2.
According to information from this body, there is a record of heart infections, although rare, in adolescents and young adults who received drugs developed by Pfizer (in partnership with BioNTech) and by Moderna, two vaccines focused on the RNA (ribonucleic acid) method.
The investigators met by the CDC re-examined cases of myocarditis and pericarditis, that is, inflammation of the myocarditis or pericarditis.
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