PARIS | France has identified five cases of myocarditis in people vaccinated with the Pfizer / BioNTech COVID-19 vaccine, with no link to the vaccine currently available, health authorities said Friday.
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“To date, five cases have been reported in France” of myocarditis, an inflammation of the heart muscle, in people who received a dose of the vaccine from American and German laboratories (Comirnaty), according to the National Agency for the Safety of Medicines (ANSM). ) at the weekly COVID vaccine monitoring station.
“The available data do not provide sufficient elements at this stage to draw conclusions about the role of the vaccine, but nevertheless represent a potential signal” from pharmacovigilance that needs to be monitored, the agency said.
It was “the report of myocarditis in young men in Israel after the second dose of Comirnaty vaccine” that prompted the Regional Centers for Pharmacovigilance (CRPV) and the ANSM Monitoring Committee “to re-analyze the relevant data. CRPV has been in France since the beginning of vaccination, ”she explains.
These side effects “will be specifically monitored and reported at European level” to the European Medicines Agency (EMA), adds ANSM. She emphasizes that they “do not question the favorable benefit / risk ratio” of the vaccine.
A total of 16,030 adverse events have been analyzed since the start of Pfizer / BioNTech vaccination, mostly “expected and not serious” such as pain at the injection site or headaches. Out of “more than 13,660,000 injections on April 22nd”.
In February, the ANSM already listed a “confirmed signal” for the Comirnaty vaccine: cases of high blood pressure immediately after vaccination or in a delayed form, short-term and with a favorable development.
Other side effects are “potential signals” or “observed”, including the occurrence of cardiac arrhythmias, macrophage activation zones and syndromes, a rare disease associated with inappropriate stimulation of these blood cells.
An additional case of atypical thrombosis has been reported for the AstraZeneca (Vaxzevria) vaccine for people over 55 years of age, with a profile similar to that of previous cases (mean age 60 years, as many women as men). and no deaths.
This brings the total number of atypical thrombosis in France to 28, including eight deaths.
For this vaccine, 12,439 cases of side effects, mainly influenza-like syndromes, were analyzed from the approximately 3.6 million doses administered in France on 22 April.