The European Medicines Agency (EMA) said the Pfizer and Moderna vaccines may be associated with rare cases of heart inflammation after analyzing 321 cases of SARS-CoV-2 vaccinations.
Myocarditis and pericarditis are inflammatory heart conditions with symptoms such as shortness of breath, palpitations, and chest pain.
The Pharmacovigilance Risk Assessment Committee (PRAC) examined 145 cases of myocarditis and 138 cases of pericarditis following Pfizer vaccination, analyzing only 19 cases of each inflammation among those who were vaccinated with Moderna.
By the end of May, approximately 177 million doses of Pfizer vaccine and 20 million doses of Moderna had been administered into the European Economic Area (EEA).
PRAC recommended updating vaccine information to include side effects and raise awareness among healthcare teams and users.
ABOUT The committee also recommended that marketing of Johnson & Johnson vaccine be limited to people with a history of capillary leakage syndrome., Clarkson’s disease.
The PRAC recommends adding a warning for Clarkson’s disease, in which fluid seeps into small blood vessels, causing swelling, low blood pressure, blood clots, and low levels of albumin in the blood.
PRAC added that the product information used in AstraZeneca, include a warning to raise awareness of cases of Guillain-Barré syndrome (SBG) that may have been reported following 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 inflammation of the heart in adolescents and young adults could be related to the Pfizer and Moderna vaccines against SARS-CoV-2.
According to information released by this body, there are records of heart inflammation, albeit rare, in adolescents and young adults who received drugs developed by Pfizer (in partnership with BioNTech) and Moderna, two RNA-based vaccines. (Ribonucleic acid).
Researchers called by the Centers for Disease Control have re-examined these cases of myocarditis and pericarditis, that is, inflammation of the heart muscle or the lining of the heart.
