France: Myocarditis cases should be watched after the Pfizer vaccine

Paris | On Friday, health authorities announced the discovery of five cases of myocarditis in France in people who were vaccinated with the Pfizer / BioNTech COVID-19 vaccine, without linking the vaccine at the moment.

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“So far, five cases have been reported in France” of myocarditis, which is an inflammation of the heart muscle, in people who received a dose of the vaccine from American and German laboratories (Commernate), according to the National Medicines Safety Agency (ANSM). ) At the Weekly COVID Vaccine Control Point.

The agency asserts that “the available data do not provide, at this stage, sufficient elements to conclude the role of the vaccine, but nonetheless constitute a possible indication” of pharmacovigilance that must be monitored.

It was “The report of myocarditis in young people in Israel after a second dose of the Commernate vaccine” that led the Regional Centers for Pharmacovigilance (CRPV) and the ANSM Monitoring Committee to analyze the relative data again. For cases of myocarditis and myocarditis that have been collected by CRPVs in France since the start of vaccination, “she explains.

These negative effects “will be the subject of specific surveillance and will be shared at European level” with the European Medicines Agency (EMA), ANSM adds. It asserts that it “does not question the positive benefit / risk ratio” of the vaccine.

Altogether, since the initiation of vaccination with Pfizer / BioNTech, 16,030 cases of adverse effects have been analyzed, most of which are “unexpected and not dangerous” effects, such as pain at the injection site or headache. The head, from “more than 13,660,000 injections carried out on April 22nd”.

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ANSM already included, in February, a “confirmed indication” regarding the Comirnaty vaccine: cases of hypertension, immediately after vaccination or on a late basis, of short duration and positive development.

D’autres effets indésirables constituent des “signaux potentiels” ou sont “sous surveillance”, notamment la survenue de troubles du rythme cardiaque, de zonas et de syndromes d’activation des macrophages, une maladie rare liée à la stimulation inappropriation de ces cells du immune system.

For the AstraZeneca (Vaxzevria) vaccine intended for people over 55 years of age, an additional case of atypical venous thrombosis was reported, representing a similar picture to previous cases (average age 60 years, number of women as of men), and no deaths.

This brings the total of these atypical clots in France to 28 cases, including eight deaths.

12,439 cases of adverse effects of this vaccine, most of them influenza-like syndromes, were analyzed from among the nearly 3.6 million doses injected in France on April 22.

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