Covid-19: cases of myocarditis to watch out for after the Pfizer vaccine

Five cases of myocarditis have been detected in France in people vaccinated with the Covid-19 vaccine from Pfizer / BioNTech, without the link with the vaccine being able to be established for the moment, health authorities announced on Friday.

“To date, five cases have been declared in France” of myocarditis, an inflammation of the heart muscle, in people who have received a dose of the vaccine from the American and German laboratories (Comirnaty), indicates the National Medicines Safety Agency ( ANSM) in its weekly Covid vaccine monitoring point.

“The available data do not provide, at this stage, enough elements to conclude on a role of the vaccine, but nevertheless constitute a potential signal” of pharmacovigilance, which must be monitored, underlines the agency.

It is “the report of myocarditis in young men in Israel after a second dose of the Comirnaty vaccine” that led the regional pharmacovigilance centers (CRPV) and the ANSM monitoring committee “to analyze the relative data again. to cases of myocarditis and myopericarditis collected by CRPVs in France since the start of vaccination, ”she explains.

These adverse effects “will be the subject of specific monitoring and will be shared at European level” with the European Medicines Agency (EMA), adds the ANSM. They “do not call into question the favorable benefit / risk ratio” of the vaccine, she emphasizes.

In total, since the start of vaccination with Pfizer / BioNTech, 16,030 cases of adverse effects have been analyzed, mostly “expected and not serious” effects such as pain at the injection site or headaches, on “more than 13,660,000 injections carried out on April 22”.

The ANSM already listed in February a “confirmed signal” concerning the Comirnaty vaccine: cases of increase in blood pressure, immediately after vaccination or in a delayed manner, of short duration and of favorable evolution.

Other side effects are “potential signals” or are “being watched”, including the occurrence of cardiac arrhythmias, zonas and macrophage activation syndromes, a rare disease associated with inappropriate stimulation of these blood cells. immune system.

For the AstraZeneca (Vaxzevria) vaccine, reserved for people over 55 years of age, an additional case of atypical thrombosis has been reported, presenting a profile similar to that of the previous cases (median age 60 years, as many women as men ), and no deaths.

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

12,439 cases of adverse effects were analyzed for this vaccine, mostly flu-like syndromes, out of around 3.6 million doses injected in France on April 22.

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