The vaccine against Covid-19 from Pfizer and BioNTech (Comirnaty) has a "
possible role
" in the occurrence of rare cases of heart inflammation in young adults, the Medicines Agency (ANSM) said on Friday.
Read also: Covid-19: five cases of myocarditis detected in people vaccinated with Pfizer
The ANSM monitoring committee "
retains the hypothesis of a possible role for the Comirnaty vaccine in the occurrence of myocarditis
", indicates its weekly monitoring point for the adverse effects of anti-Covid vaccines. Last week, the same committee had indicated the "
need to continue monitoring the potential signal
".
The ANSM had classified at the end of April this undesirable effect as a “
potential signal
” of pharmacovigilance of the Pfizer / BioNTech vaccine after the report of a similar case in Israel. Out of 29 cases reported since the start of the follow-up in France, 14 were retained "
in view of the level of completeness of the clinical data collected
", and for nine of them, the clinical and pharmacological expertise concluded that the vaccine, details the ANSM. The majority are men (9 out of 14), median age of 28, the vast majority (93%) "
recovered or in the process of recovery
".
In total, since the start of vaccination with Pfizer / BioNTech, 25,983 cases of adverse effects have been analyzed, mostly “
expected and not serious
”
effects
such as pain at the injection site or headaches, out of more than 32.9 million injections performed as of June 10.
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.
"Potential signals"
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 vaccine (Vaxzevria), reserved for people over 55 years of age, 2 additional cases of atypical thrombosis were reported between June 4 and 10, presenting a profile similar to that of the previous cases (median age of 61 years, as many women as men), and no deaths.
This brings the total of these atypical thromboses in France to 52, including 13 deaths. 18,723 cases of adverse effects were analyzed for this vaccine, mostly flu-like syndromes, out of around 5.7 million doses injected in France on June 10.
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