The European Medicines Agency (EMA) has issued a warning that two of the main Covid-19 vaccines in use in Europe carry a risk of side-effects affecting the heart.
The warning, which concerns the Pfizer/BioNTech and Moderna vaccines, is to be included in the document delivered with the drugs to inform users of the possible dangers.
The two problems concern inflammation of the heart muscle, or myocarditis, and inflammation of the sac which surrounds the heart, known as pericarditis.
Symptoms include shortness of breath, irregular heart rhythm and chest pain.
At the same time, the EMA is also recommending not to use the Johnson & Johnson vaccine for people who have a history of systemic capillary leak syndrome (SCLS), a rare disorder that leads to recurrent attacks associated with a rapid fall in blood pressure when fluid leaks from the smaller blood vessels or capillaries.
Last month the EMA issued a similar warning regarding SCLS patients in respect to the AstraZeneca vaccine.
In all of these cases, the likelihood of side-effects such as described is vanishingly small. However the responsibility of the EMA is to study evidence of side-effects, and if they appear linked to the use of the medication in question, to bring that to the attention of the medical and pharmaceutical professions.
Prescription drugs (and many OTC medications) contain a document inside the packaging setting out in great detail the applications of the drug as well as side effects. Most people do not read them, nor indeed would it mean much if they did.
But the inclusion of the information is a legal requirement, and the information should in any case be known to prescribing doctors and the pharmacists who deliver the drugs. They should be the people to turn to for more information, either as a precaution or in the case a side-effect is suspected.
The EMA’s conclusions are based on examination of 145 cases of myocarditis following a Pfizer vaccination, and 19 following Moderna, as well as 138 cases of pericarditis after Pfizer and 19 after Moderna.
The samples were taken in the European Economic Area, which saw 177 million doses of Pfizer and 20 million Moderna being administered.
