The EMA assesses the possible link between Moderna and capillary leakage

This content was published on October 29, 2021 – 2:22 PM

The Hague, Oct 29 (EFE) .- The European Medicines Agency (EMA) announced this Friday that it has begun to study with the available data if there is a link between Moderna’s covid-19 vaccine and several registered cases of syndrome capillary extravasation.

The European institution has begun the review of what is known as a “safety signal” of this “very rare” disorder in six people who received an injection of Moderna (Spikevax, as a trade name).

This syndrome causes a loss of fluid from the small blood vessels (capillaries), resulting in swelling mainly in the arms and legs, as well as low blood pressure, thickening of the blood and low levels of albumin in the blood (an important blood protein ).

The information on these cases was reported in the European database of possible side effects (EudraVigilance) by countries of the European Economic Area (EEA), which includes the 27 of the European Union (EU), in addition to Iceland, Liechtenstein and Norway.

The beginning of this research does not necessarily mean that there is a cause-effect relationship with the vaccine, since a “safety signal” occurs after health professionals have reported adverse effects that occurred coinciding with the use of a drug or a vaccine, which warrants an investigation.

On the other hand, the agency explained this Friday that its safety committee (PRAC) does not have enough evidence linking covid-19 vaccines with several very rare cases of multisystemic inflammatory syndrome (MIS).

It is a rare, serious inflammatory disease that affects many parts of the body, and symptoms can include tiredness, persistent severe fever, diarrhea, vomiting, stomach, headache, and chest pain, as well as shortness of breath.

The PRAC will continue to monitor any new reports of this syndrome in people who received the vaccine and urges health workers to report any new cases.

The EMA is also evaluating more data on the risk of developing myocarditis and pericarditis, both inflammatory heart conditions, after receiving one of the mRNA vaccines (Pfizer and Moderna).

The PRAC had already reviewed cases of myocarditis and pericarditis in an evaluation that concluded in July and then recommended that both conditions be noted as a possible side effect in the package insert for the two vaccines.

But this committee has now asked the pharmaceutical companies that developed both preparations to “conduct an in-depth review of all published data on the association with myocarditis and pericarditis, including data from clinical trials, data from the (scientific) literature, and available information. in the public domain ”. EFE

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