No serious adverse effects were observed in France during this second week of vaccination with the Pfizer / BioNTech vaccine.
A case of a non-serious effect was recorded, the drug agency said.
No serious adverse effects were observed in France during this second week of vaccination with Pfizer / BioNTech's vaccine against Covid-19, the ANSM drug agency said on Friday.
"A case of non-serious adverse effect has been recorded in the national pharmacovigilance database. It concerns a temporary decrease in certain immune cells (lymphocytes)", specifies the health agency in an information point.
Although already observed in clinical trials, this non-serious side effect has not yet been included in the package leaflet.
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"Possible to vaccinate patients with severe allergy"
The ANSM says it is "also attentive to the reports of adverse effects that have occurred in other countries" in which this vaccine marketed under the name of Comirnaty is used.
The analysis of allergic reaction cases that she requested from a pharmacovigilance center "confirms the extremely rare occurrence of serious allergic reactions".
This vigilance on cases of serious allergies continues with the aim of better identifying possible people at risk of allergic reactions.
The day after the start of the vaccination campaign with the Pfizer / BioNTech vaccine in the United Kingdom, two cases of severe allergy had marked the spirits.
But "it is possible to vaccinate with the Pfizer / BioNTech vaccine patients who have a serious drug or food allergy," the French Allergology Federation stressed on Monday.
The contraindication only concerns patients who are allergic to one or other of the ingredients contained in this vaccine, she continued, mentioning in particular polyethylene glycol (PEG) which could be implicated.