The Spanish Agency for Medicines and Health Products ( AEMPS ) has echoed this Monday the update issued by the Committee for the Evaluation of Risks in European Pharmacovigilance (PRAC) regarding the existing risk in the vaccines Comirnaty (BioNTech / Pfizer ) and Spikevax ( Modern ) of two cardiac complications, specifically pericarditis and myocarditis.
Specifically, the organism, based on the extracted from two large observational studies made from data from the French National Health System and Nordic registries respectively, concludes that the risk of suffering from these conditions is indeed slightly higher for young men after the administration of the second dose, something that was already included in the leaflets of both sera.
Data consistent with those already available
However, they also point out that the incidence of these complications is very low and that they tend to have a benign course, for which they argue that the benefits of vaccination (which considerably reduces hospitalizations and deaths from serious complications of covid-19) outweigh far beyond its risks, as has already been pointed out on numerous occasions.
More specifically, the French study shows that the additional incidence (that is, the difference from an unvaccinated population) of pericarditis or myocarditis as a whole in men between 12 and 29 years of age is three cases per 100,000 with the Pfizer vaccine and 13 cases per 100,000 with Moderna. Similarly, the Nordic study concludes that in the 28 days after the administration of the second dose of the vaccine, the additional incidence in men between 16 and 24 years of age is 6 cases per 100,000 for Pfizer serum and 19 per every 100,000 for Moderna.
All this, recalls the PRAC, is consistent with the information previously available and confirms the previous hypotheses regarding the risk of these complications after vaccination. Therefore, this update does not imply any change in the recommendations or in the technical specifications of these two vaccines.
The AEMPS concludes by emphasizing that the balance between the benefit and the risk of vaccination with these formulas continues to be favorable , since the decrease in mortality and serious illness due to the covid that it produces is very important and the appearance of the symptoms of myocarditis and pericarditis (usually benign course) is very rare.