During its weekly Covid vaccine monitoring update, the National Medicines Safety Agency (ANSM) indicated that five cases of myocarditis have been detected in France in people vaccinated with the Covid-19 vaccine from Pfizer / BioNTech .
For the time being, no link between this inflammation of the heart muscle and the vaccine has been established.
"The available data do not provide, at this stage, sufficient elements to conclude on a role of the vaccine, but nevertheless constitute a potential signal" of pharmacovigilance, which must be monitored, underlines the agency.
No questioning of the benefit / risk ratio of the vaccine
It was "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.
Mostly "expected and not serious" effects
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 increased 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.
28 cases of thrombosis with AstraZeneca
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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